Pharmaceuticals

Aadi Global has grown steadily and has been recognized as an established player in manufacturing of Pharmaceutical APIs, Excipients and Intermediates. Over the years, Aadi Global has built an undeniable reputation for its specialization in early identification, development and introduction of new molecules, in a continuous assessment. We invest thoroughly in generic R&D activities, both for process development for API as well as formulation development for dosage forms. Our facilities are in a state of constant & continuous upgrade, to keep pace and achieve constant growing demands of the dynamic International scenario. Blending of human skills and innovative expertise of Aadi Global often acts as a catalyst for development of desired modern technology and setting up of world class facilities. Our philosophy of sustained growth and consolidation is achieved by strategic tie-ups with several globally renowned players. Today, we can boast of having tie-ups with market leaders in almost all the strategically important emerging markets.

Gelatin

Gelatin
Technical Details
Product Bone Gelatin
Grade RC-240 & RC-210
CAS No 9000-70-8
Mol. Formula Not applicable
Mol. Weigh Not applicable

 

 

Specification
Description Light amber to faintly yellow, translucent flakes, sheets, shreds, powder or granules; odour, slight.
Identification:

A. Addition of 0.05 ml of CuSO4solution and 0.5 ml of 2 M NaOH to 2 ml pf 1% w/w substance solution

B. Heating at 60 0C and then cooling at 0 0C of 5 % w/w solution

 

– Gives violet colour

 

 

– Gives very viscous solution

Appearance of solution To comply with test of Pharmacopoeia
pH (1% w/v) 3.8 – 7.6
Arsenic Not more than 2 ppm
Heavy metals Not more than 50 ppm
Sulphur dioxide Not more than 200 ppm
Microbial contamination:

A. TAMC

B. E. Coli

C. Salmonellae

 

– Not more than 1000 CFU/gm

– Absent in 1.0 gm

– Absent in 10.0 gm

Ash Not more than 3.25 % w/w
Loss on drying (105 0C for 2 hr) Not more than 16.0 % w/w
Jelly strength > 200
Viscosity > 40
Technical Details
Product Bone Gelatin
Grade RC-180 & RC-150
CAS No 9000-70-8
Mol. Formula Not applicable
Mol. Weigh Not applicable

 

Specification
Description Light amber to faintly yellow, translucent flakes, sheets, shreds, powder or granules; odour, slight.
Identification:

A. Addition of 0.05 ml of CuSO4solution and 0.5 ml of 2 M NaOH to 2 ml pf 1% w/w substance solution

B. Heating at 60 0C and then cooling at 0 0C of 5 % w/w solution

 

– Gives violet colour

 

 

– Gives very viscous solution

Appearance of solution To comply with test of Pharmacopoeia
pH (1% w/v) 3.8 – 7.6
Arsenic Not more than 2 ppm
Heavy metals Not more than 50 ppm
Sulphur dioxide Not more than 200 ppm
Microbial contamination:

A. TAMC

B. E. Coli

C. Salmonellae

 

– Not more than 1000 CFU/gm

– Absent in 1.0 gm

– Absent in 10.0 gm

Ash Not more than 3.25 % w/w
Loss on drying (105 0C for 2 hr) Not more than 16.0 % w/w
Jelly strength < 200
Viscosity < 40
Technical Details
Product Bone Gelatin
Grade RP-240 & RP-180
CAS No 9000-70-8
Mol. Formula Not applicable
Mol. Weigh Not applicable

 

 

Specification
Description Light amber to faintly yellow, translucent flakes, sheets, shreds, powder or granules; odour, slight.
Identification:

A. Addition of 0.05 ml of CuSO4solution and 0.5 ml of 2 M NaOH to 2 ml pf 1% w/w substance solution

B. Heating at 60 0C and then cooling at 0 0C of 5 % w/w solution

 

– Gives violet colour

 

 

– Gives very viscous solution

Appearance of solution To comply with test of Pharmacopoeia
pH (1% w/v) 3.8 – 7.6
Arsenic Not more than 2 ppm
Heavy metals Not more than 50 ppm
Sulphur dioxide Not more than 200 ppm
Microbial contamination:

A. TAMC

B. E. Coli

C. Salmonellae

 

– Not more than 1000 CFU/gm

– Absent in 1.0 gm

– Absent in 10.0 gm

Ash Not more than 3.25 % w/w
Loss on drying (105 0C for 2 hr) Not more than 16.0 % w/w
Jelly strength ~ 200
Viscosity ~ 35
Technical Details
Product Bone Gelatin
Grade RE-120 & Technical grade
CAS No 9000-70-8
Mol. Formula Not applicable
Mol. Weigh Not applicable

 

Specification
Description Light amber to faintly yellow, translucent flakes, sheets, shreds, powder or granules; odour, slight.
Identification:

A. Addition of 0.05 ml of CuSO4solution and 0.5 ml of 2 M NaOH to 2 ml pf 1% w/w substance solution

B. Heating at 60 0C and then cooling at 0 0C of 5 % w/w solution

 

– Gives violet colour

 

 

– Gives very viscous solution

Appearance of solution To comply with test of Pharmacopoeia
pH (1% w/v) 3.8 – 7.6
Arsenic Not more than 2 ppm
Heavy metals Not more than 50 ppm
Sulphur dioxide Not more than 200 ppm
Ash Not more than 3.25 % w/w
Loss on drying (105 0C for 2 hr) Not more than 16.0 % w/w

Active Pharmaceutical Ingredients

APIs can be manufactured as per pharmacopoeia guidelines of various countries, as well as per customer specifications. They will be produced according to client requirements without infringing patent laws and with all pertinent documentations.

Uses of Product:

It acts as anamebicidal and so used in the treatment of amoebiasis, Balantidiasis (an infection caused by protozoa).

 

Technical Details
CAS No 83-73-8
Mol. Formula C9H5I2NO
Mol. Weigh 396.95
Category Antiamoebic

 

Specification
Description Light yellowish to yellowish brown, microcrystalline powder; odourless or with a faint odour
Solubility Sparingly soluble in alcohol and in ether; practically insoluble in water
Acidity or Alkalinity Passes as per Pharmacopoeia
Free Iodine & Iodine Passes as per Pharmacopoeia
Related Substance Passes as per Pharmacopoeia
Residue on ignition/Sulphated ash Not more than 0.1 % w/w
Loss on drying Not more than 0.5 % w/w
Assay Between 97.0 and 100.5 % w/w

Uses of Product:

It has primarily been used as an anti-diarrheal medication. It is used in the treatment of acute and chronic amoebic dysentery, colitis, in GItrack infections like amoebiasis, in dermatophytosis, mycosis barbae. seborrhoeicdermatitis, infected eczema, furunculosis and pityriasis versicoior {athlete’s foot}, ermatitis, Impetigo, monilial and trichomonas vaginitis, Giardiasis.

 

Technical Details
CAS No 130-26-7
Mol. Formula C9H5ClINO
Mol. Weigh 305.5
Category Antiamoebic & Topical Anti-infective

 

Specification
Description Yellowish white to brownish yellow powder; odour, faint and characteristic
Solubility Practically insoluble in water, sparingly soluble in methylene chloride, soluble in hot ethyl acetate and in hot glacial acetic acid, Freely soluble in dimethylformamide and in pyridine
Melting Point About 180 째C
Acidity or Alkalinity Passes as per Pharmacopoeia
Halides Not more than 140 PPM
Free Iodine & Iodine Passes as per Pharmacopoeia
Related Substance Passes as per Pharmacopoeia
Residue on ignition/Sulphated ash Not more than 0.1 % w/w
Loss on drying Not more than 0.5 % w/w
Assay Between 97.0 and 100.5 % w/w

Uses of Product:

  • It is often used to prevent surgical skin infection in any major operations. As a surgical scrub, it is broadly applicable for pre and post operative skin cleansing.
  • It works like antibacterial in dental procedures.
  • Works great as antiseptic cleanser for surgeons before surgery.
  • Most suitable for the treatment and prevention against infection in ulcers, burns and cuts.
  • Effective against the treatment of wounds, yeasts, molds, fungi, protozoans, viruses, etc.
  • It is used as a dispersing and suspending agent in drugs and as a plasma volume expander

 

Technical Details
CAS No 25655-41-8
Mol. Formula (C6H9NO)n•xI
Category Antiamoebic & Topical Anti-infective

 

Specification
Description Yellowish brown or reddish brown amorphous powder; odour slight and characteristic of iodine
Solubility Soluble in water and in alcohol, practically insoluble in chloroform, in carbon tetrachloride, in ether, in solvent hexane, and in acetone
pH of 10% solution 1.5 to 5.0
Iodide Not more than 6.0 % w/w
Nitrogen Between 9.5 and 11.5 % w/w
Heavy metals Passes as per Pharmacopoeia
Loss on drying Not more than 8.0 % w/w
Residue on ignition/Sulphated ash Not more than 0.025 % w/w
Assay Between 9 and 12 % w/w

Uses of Product:

Potassium iodide salt is suitable against yeasts, molds, fungi, viruses, and protozoan. It is good for treating skin infections and other wound treatments. The other use of potassium iodide salts is as a cosmetic agent. It is suitable for pre- and post-operative skin cleansing and can also be used a surgical scrub. Potassium Iodide salts are good for treating ulcers, cuts, bumps etc. It is better to use this products under expert’s advice only.

 

Technical Details
CAS No 7681-11-0
Mol. Formula KI
Mol. Weigh 166
Category Antithyroid & Antifungal

 

Specification
Description White or almost white powder or colourless crystals; odourless
Solubility Very soluble in water and even more soluble in boiling water, freely soluble in glycerol, soluble in ethanol
Appearance of solution 10 % aqueous solution is clear and colourless
Alkalinity Passes as per Pharmacopoeia
Iodates Passes as per Pharmacopoeia
Sulphates Passes as per Pharmacopoeia
Thiosulphates Passes as per pharmacopoeia
Heavy metals Passes as per Pharmacopoeia
Potassium Passes as per pharmacopoeia
Barium Passes as per pharmacopoeia
Nitrate, Nitrite & Ammonia Passes as per pharmacopoeia
Iron Passes as per pharmacopoeia
Loss on drying Not more than 1.0 % w/w
Assay Between 99.0 and 100.5 % w/w

Uses of Product:

It is used to treat and prevent iodine deficiency. It is used in thyroid function tests and thyroid imaging and to treat hyperthyroidism and thyroid carcinoma.

 

Technical Details
CAS No 7681-82-5
Mol. Formula NaI
Mol. Weigh 149.89
Category Expectorant & Iodine Supplement

 

Specification
Description White or almost white, crystalline powder or colourless crystals; odourless; hygroscopic
Solubility Very soluble in water, freely soluble in alcohol and in glycerin
Appearance of solution 10 % aqueous solution is clear and colourless
Alkalinity Passes as per Pharmacopoeia
Iodates Passes as per Pharmacopoeia
Sulphates Passes as per Pharmacopoeia
Thiosulphates Passes as per pharmacopoeia
Heavy metals Passes as per Pharmacopoeia
Potassium Passes as per pharmacopoeia
Barium Passes as per pharmacopoeia
Nitrate, Nitrite & Ammonia Passes as per pharmacopoeia
Iron Passes as per pharmacopoeia
Loss on drying Not more than 2.0 % w/w
Assay Between 99.0 and 100.5 % w/w

Uses of Product:

It is used as a dough conditioner.
It is an oxidant added to lotions and ointments as an antiseptic, disinfectant and deodorant.
It is used in animal feed to correct iodine deficiency and prevent various animal diseases.
In food industry it is used for iodization of table salt.

 

Technical Details
CAS No 41372-10-5
Mol. Formula (C4H10N2)3,2C6H8O7
Mol. Weigh 642.7
Category Anthelmintic

 

Specification
Description A white or almost white granular powder, almost odourless
Melting Point About 190 ºC
Solubility Freely soluble in water, practically insoluble in alcohol and in ether
Appearance of solution 5% aqueous solution is clear and colourless
pH of 5% solution Between 5.0 and 6.0
Heavy metals Passes as per Pharmacopoeia
Related substances / Chromatographic purity Passes as per Pharmacopoeia
Sulphated ash Not more than 0.1 % w/w
Water Not more than 12 % w/w
Assay Between 98.0 and 100.5 % w/w

Uses of Product:

It is used to effectively eliminate threadworms (pinworms) and roundworms from the bowel of children, dogs, and cats.

 

Technical Details
CAS No 18534-18-4
Mol. Formula C4H10N2•H3PO4•H2O
Mol. Weigh 202.15
Category Anthelmintic

 

Specification
Description White crystalline powder; odourless or almost odourless
Solubility Sparingly soluble in water; practically insoluble in ethanol
pH of 5% solution Between 6.0 and 6.5
Heavy metals Passes as per Pharmacopoeia
Chromatographic purity Passes as per Pharmacopoeia
Water Between 8.0 % and 9.5 % w/w
Assay Between 98.5 and 100.5 % w/w

Uses of Product:

Piperazine adipate is used to treat intestinal roundworms or pinworm infection found inside both humans and farm animals.

 

Technical Details
CAS No 142-88-1
Mol. Formula C4H10N2•C6H10O4
Mol. Weigh 232.28
Category Anthelmintic

 

Specification
Description White or almost white crystalline powder
Melting Point About 250˚C
Solubility Soluble in water, practically insoluble in alcohol
Appearance of solution 5% aqueous solution is clear and colourless
pH of 5% solution Between 5.0 and 6.0
Heavy metals Passes as per Pharmacopoeia
Related substances / Chromatographic purity Passes as per Pharmacopoeia
Sulphated ash / Residue on ignition Not more than 0.1 % w/w
Water Not more than 0.5 % w/w
Assay Between 98 and 101 % w/w

Uses of Product:

Piperazine Hexahydrate is used for treating common roundworms and pinworms infection.

 

Technical Details
CAS No 142-63-2
Mol. Formula C4H10N2•6H2O
Mol. Weigh 194.23
Category Anthelmintic

 

Specification
Description Colourless, glassy deliquescent crystals
Melting Point About 43˚C
Solubility Freely soluble in water and in alcohol; slightly soluble in ether
Appearance of solution 5 % aqueous solution is clear and colourless
pH of 5% solution Between 10.5 and 12.0
Heavy metals Passes as per Pharmacopoeia
Related substances Passes as per Pharmacopoeia
Sulphated ash Not more than 0.1 % w/w
Assay Between 98.0 and 101.0 % w/w

Uses of Product:

It is used as a one-day wormer, either in water or feed, for the control of round worms in poultry, swine, and horses. It also controls nodular worms in swine, and small strongyles in horses.

 

Technical Details
CAS No 142-64-3
Mol. Formula C4H10N2•2HCl
Mol. Weigh 159.08
Category Anthelmintic

 

Specification
Description White crystalline powder
Solubility Soluble in water, practically insoluble in alcohol
pH of 5% solution Between 3.0 and 3.4
Residue on ignition Not more than 0.1 % w/w
Chromatographic purity Passes as per Pharmacopoeia
Heavy metals Passes as per the test
Water Not more than 10 % w/w
Assay Between 98.5 and 100.5 % w/w

Uses of Product:

  • Mainly used as food additive and preservative
  • The anticoagulant in blood transfusions
  • Used to relieve discomfort in urinary tract infections
  • It also works as buffering agent in food and acidity regulator as antacid
  • Used as a sequestrant – to improve the quality and stability of the food products
  • Used as an emulsifier – to stabilize processed foods like cheese

 

Technical Details
CAS No 6132-04-3
Mol. Formula C6H5Na3O7•2H2O
Mol. Weigh 294.1
Category Anticoagulant

 

Specification
Description White or almost white, crystalline powder or granular crystals
Solubility Freely soluble in water and very soluble in boiling water; insoluble in alcohol and in ether
Appearance of solution 10% aqueous solution is clear and colourless
Acidity or Alkalinity Passes as per the Pharmacopoeia
Chlorides Passes as per Pharmacopoeia
Sulphates Passes as per Pharmacopoeia
Heavy metals Passes as per Pharmacopoeia
Arsenic Passes as per Pharmacopoeia
Oxalates Passes as per Pharmacopoeia
Readily carbonisable substances Passes as per Pharmacopoeia
Tartrate Passes as per Pharmacopoeia
Pyrogens Passes as per Pharmacopoeia
Water Between 11.0 and 13.0 % w/w
Assay Between 99.0 and 100.5 % w/w

Uses of Product:

Used to make urine less acidic by helping the kidneys get rid of uric acid, thereby helping to prevent gout and kidney stones.

 

Technical Details
CAS No 6100-05-6
Mol. Formula C6H5K3O7•H2O
Mol. Weigh 324.42
Category Anticoagulant

 

Specification
Description White or almost white, granular powder or transparent crystals; odourless; hygroscopic
Solubility Very soluble in water, practically insoluble in alcohol
Appearance of solution 10% aqueous solution is clear and colourless
Acidity or Alkalinity Passes as per Pharmacopoeia
Sodium Not more than 0.3 % w/w
Chlorides Passes as per Pharmacopoeia
Sulphates Passes as per Pharmacopoeia
Heavy metals Passes as per Pharmacopoeia
Arsenic Passes as per Pharmacopoeia
Oxalates Passes as per Pharmacopoeia
Readily carbonisable substances Passes as per Pharmacopoeia
Tartrate Passes as per Pharmacopoeia
Loss on drying / Water Between 4.0 and 6.0 % w/w
Assay Between 99.0 and 100.5 % w/w

Uses of Product:

Used to treat various tissue diseases and other health problems. It is also good for intestinal treatment, chronic and acute amoebic dysentery.

 

Technical Details
CAS No 3736-81-0
Mol. Formula C14H11Cl2NO4
Mol. Weigh 328.15
Category Antiamoebic & Antiprotozoal

 

Specification
Description White or almost white, crystalline powder; odourless or almost odourless
Solubility Freely soluble in chloroform; slightly soluble in alcohol and in ether; very slightly soluble in water
Melting Point Between 114 and 116˚C
Free acidity Passes as per Pharmacopoeia
Related substances / Compounds Passes as per Pharmacopoeia
Sulphated ash / Residue on ignition Not more than 0.1 % w/w
Loss on drying Not more than 0.5 % w/w
Assay Between 98.0 and 102.0 % w/w

Uses of Product:

It is used as an anthelmintic against tapeworms and other intestinal fluke infections.

 

Technical Details
CAS No 50-65-7
Mol. Formula C13H8Cl2N2O4•H2O
Mol. Weigh 345.1
Category Anthelmintic

 

Specification
Description Yellowish fine crystals
Solubility Practically insoluble in water; sparingly soluble in acetone; slightly soluble in anhydrous ethanol
Melting Point 227 to 232 °C
Related substances Passes as per Pharmacopoeia
5-Chlorosalicylic acid Not more than 60 PPM
2-Chloro-4-nitroaniline Not more than 100 PPM
Chlorides Not more than 500 PPM
Sulphated ash Not more than 0.1 % w/w
Loss on drying Between 4.5 and 6.0 % w/w
Assay Between 98.0 and 101.0 % w/w

Uses of Product:

Used for the treatment, control, prevention, & improvement of blood coagulation and urinary bladder calculi.

Uses of Product:

Can be used in flavorings, cosmetics, candy, gelatin, jams, jellies, soft drinks and fruit. It has the ability to minimize discoloration and retain flavor and vitamins.

Uses of Product:

A powerful irritant and carminative used as counter irritant in lumbago and neuralgia. It can also be used to treat stomach ache that involves poorly functioning stomach muscles and as an antibacterial agent.

 

Technical Details
CAS No 8023-77-6
Category Stomachic and Carminative

 

Specification
Description Red to brownish red oily viscous liquid
Odor Pungent and characteristic of chillies
Taste Highly pungent
Solubility Soluble in alcohol, in acetone, in ether in chloroform and in volatile oils
Color 1000 c.u. to 10,000 c.u.
Residual Solvent Not more than 20 PPM
Capsaicin content Not less than 8 %(Other grade 2 % to 20 %)

Uses of Product:

Used to break up phlegm, to treat respiratory diseases related to excessive mucus.

 

Technical Details
CAS No 23828-92-4
Mol. Formula C13H18Br2N2O·HCl
Mol. Weigh 414.56

 

Specification
Description A White or yellowish crystalline powder
Solubility:

A. Methanol

B. Water

C. Methylene Chloride

 

– Soluble

– Sparingly soluble

– Practically insoluble

Identification:

A. UV Absorption (245 nm)

B. IR Spectrum

C. TLC

D. Test of chloride

 

– Ratio: 3.2 – 3.4

– To comply

– To comply

– To comply

Appearance of solution

(5% Methanolic solution)

Clear and colourless
pH (1 % w/v in water) 4.5 -6.0
Heavy metals Not more than 20 ppm
Loss on drying (105 0C) Not more than 0.5 % w/w
Sulphated ash Not more than 0.1 % w/w
Related substances To comply with test of pharmacopoeia
Residual solvent To comply with test of relevant pharmacopoeia
Assay 99.0 % w/w – 101.0 % w/w

Uses of Product:

Used as an expectorant to treat coughs and congestion.

 

Technical Details
CAS No 93-14-1
Mol. Formula C10H14O4
Mol. Weigh 198.2

 

Specification
Description White or almost white, crystalline powder; odourless or a slight characteristic odour
Solubility:

A. Water, Chloroform, Alcohol. Propylene glycol

B. Glycerin

 

– Soluble

 

– Sparingly soluble

Identification:

A. IR spectrum

B. UV Absorption

C. Chemical test

 

– To comply

– To comply

– Cherry-red to purple colour

Melting ranges 79 0C – 83 0C
Appearance of solution 2.0 % w/v solution is clear and colourless
Heavy metals Not more than 25 ppm
Loss on drying (60 0C for 3 hr) Not more than 0.5 % w/w
Assay (on dried basis) 98.0 % w/w – 101.5 % w/w

Intermediates

Intermediates can be manufactured as per pharmacopoeia guidelines of various countries, as well as per customer specifications. They will be produced according to client requirements without infringing patent laws and with all pertinent documentations.
Technical Details
CAS No 96-99-1

 

Specification
Description White crystalline powder.
Melting Point 178-1820C
Technical Details
CAS No 56107-02-9

 

Specification
Description Yellow crystalline powder.
Melting Point 102-1070C

 

Technical Details
CAS No 31431-19-3

 

Specification
Description Yellow amorphous powder.
Melting Point 141-1440C

 

 

 

Technical Details
CAS No 39070-63-8

 

Specification
Description Yellow crystalline powder.
Melting Point 114-1180C
Technical Details
CAS No 54965-21-8

 

Specification
Description Cream amorphous powder

TYPICAL CERTIFICATE OF ANALYSIS

 

Client Name: XYZ

Name of the Product: Disodium Edetate Dihydrate

 

Mfg. dt.: FEB 2018                                                             Batch No.: DSE/D/1718/001

Exp. dt.: JAN 2023                                                             A.R. No.: QC/180203/27

Release dt.: 03/02/2018                                                    Analysis dt.: 03/02/2018

IN-HOUSE TEST CARRIED OUT

 

Sr. No Tests Specifications Results
1 Description A white, crystalline powder; odorless Conforms to the specification
2 Solubility Soluble in water; practically insoluble in ethanol 95 % Conforms to the specification
3 Identification A Infrared absorption spectrophotometry  

Passes the test

Identification B No precipitate should be produced No precipitate is produced
Identification C No precipitate should be produced No precipitate is produced
Identification D Gives the reactions of sodium salts Passes the test
4 Appearance of solution 5.0 % w/v solution Clear and colorless Clear and colorless
5 pH of 5.0 % w/v solution 4.0 to 5.5 5.41
6 Impurity A As per the test Passes the test
7 Heavy metals Not more than 20 PPM Passes the test
8 Iron Not more than 80 PPM Passes the test
9 Loss on drying Between 8.7 and 11.4 % 9.53 %
10 Assay (on dry basis) Between 98.5 and 101 % 99.17 %

 

Remark: The product complies with the in-house standards of quality.

Uses of Product:

Used as anthelmintic for treatment of tapeworm infections.

 

Technical Details
CAS No 54965-21-8
Mol. Formula C12H15N3O2S
Mol. Weigh 265.33

 

Specification
Identification:

A. IR Spectrum

B. RF Value

 

– To comply

– To comply

Loss on drying (105 0C, 4 hr) Not more than 0.5 % w/w
Residue on ignition Not more than 0.2 % w/w
Chromatographic purity To comply
Residual solvent To comply with test of relevant pharmacopoeia
Assay 98.0 % w/w – 102.0 % w/w

Uses of Product:

Used as anthelmintic in treatment for infections of pinworm, whipworm, roundworm, hookworm.

 

Technical Details
CAS No 31431-39-7
Mol. Formula C16H13N3O3
Mol. Weigh 295.29

 

Specification
Identification (IR Spectrum) To comply
Loss on drying (105 0C, 4 hr) Not more than 0.5 % w/w
Residue on ignition Not more than 0.1 % w/w
Heavy metal Not more than 0.002 % w/w
Chromatographic purity To comply
Residual solvent To comply with test of relevant pharmacopoeia
Assay 98.0 % w/w – 102.0 % w/w

Excipients

Excipients (superdisintegrants) can be manufactured as per pharmacopoeia guidelines of various countries, as well as per customer specifications. They will be produced according to client requirements without infringing patent laws and with all pertinent documentations.

SPECIFICATION

 

Name of the Product: Croscarmellose Sodium U.S.P. / N.F.

 

No. TESTS SPECIFICATIONS

(U.S.P. 38 / N.F. 33)

1. Identification A. Settled as a blue, fibrous mass with methylene blue solution.
B. Reddish-violet colour developed at interface with1-naphthol solution and sulfuric acid
C. Gives test of Sodium.
2. Residue on ignition (%) (On dried basis) 14.0  to 28.0
3. Heavy metals (ppm) NMT 10.0 ppm
4. Sodium chloride and sodium glycolate (%) The sum of the percentages of sodium chloride and sodium glycolate is NMT  0.5%
5. Content of water soluble substances (%) NMT 10.0%
6. Degree of substitution 0.60 to 0.85, calculated with reference to the dried substance.
7. Loss on drying (%) NMT 10.0%
8. Microbial contamination:

a)    TAMC

b)   TYMC

c)    Escherichia coli   

 

NMT 1000 cfu/g

NMT 100 cfu/g

Absent

9. pH (1% w/v  in water) 5.0  to 7.0
10. Settling volume (ml) 10.0 to 30.0

 

 

TYPICAL CERTIFICATE OF ANALYSIS

 

Client Name: XYZ

Name of the Product: Croscarmellose Sodium U.S.P. / N.F. 

Mfg. dt.: MAR 2018                                                                    Batch No.: 01117/18

Exp. dt.: FEB 2023                                                                      Quantity: 25 kg

 

No. TESTS RESULTS SPECIFICATIONS

(U.S.P. 38 /N.F. 33)

1. Description White or greyish white powder. —-
2. Identification Complies with tests A, B & C. A. Settled as a blue, fibrous mass with methylene blue solution.
B. Reddish-violet colour developed at interface with1-naphthol solution and sulfuric acid
C. Gives test of Sodium.
3. Residue on ignition (%) (On dried basis) 15.8 % 14.0  to 28.0
4. Heavy metals (ppm) Below 10 NMT 10.0 ppm
5. Sodium chloride and sodium glycolate (%) Below 0.5 The sum of the percentages of sodium chloride and sodium glycolate is NMT  0.5%
6. Content of water soluble substances (%) Below 10 NMT 10.0%
7. Degree of substitution 0.67 % 0.60 to 0.85, calculated with reference to the dried substance.
8. Loss on drying (%) 4.9 % NMT 10.0%
9. Microbial contamination:

a)     TAMC

b)    TYMC

c)     Escherichia coli   

 

Below 1000

Below 100

Absent

 

NMT 1000 cfu/g

NMT 100 cfu/g

Absent

10. pH (1% w/v  in water) 6.3 5.0  to 7.0
11. Settling volume (ml) 20 ml 10.0 to 30.0

  

REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P.

SPECIFICATION

                                                                                                                                              

Name of the Product: Carboxymethylcellulose Calcium U.S.P. / N.F.  

 

No. TESTS SPECIFICATIONS  

(U.S.P.38 / N.F.33)                  

1. Identification A. Gives Red-purple color develops in Carboxymethylcellulose Calcium solution in Sodium Hydroxide with chromotorpic acid on heating.
B. Gives white, flocculent precipitate with acetone.
C. Gives white, flocculent precipitate with ferric chloride solution.
D. Test of Calcium.
2. Residue on Ignition 10.0 % – 20.0 %
3. Chloride And Sulphate Chloride : NMT 0.36%

Sulfate : NMT 1.0 %

4. Alkalinity No red colour develops with phelolphthalein
5. Loss on drying (%) (Dried at 1050 C for 3 hr) NMT 10.0 %

 

 

TYPICAL CERTIFICATE OF ANALYSIS

 

Client Name: XYZ

Name of the Product: Carboxymethylcellulose Calcium U.S.P. / N.F.

Mfg. dt.: MAR 2018                                                                    Batch No.: 12003/18

Exp. dt.: FEB 2023                                                                      Quantity: 25 kg

 

No. TESTS RESULT SPECIFICATIONS  

(U.S.P.38 / N.F.33)                  

1. Description White or yellowish-white powder, hygroscopic after drying. ______
2. Identification   A. Gives Red-purple color develops in Carboxymethylcellulose Calcium solution in Sodium Hydroxide with chromotorpic acid on heating.
Complies with Test A, B, C and D. B. Gives white, flocculent precipitate with acetone.
C. Gives white, flocculent precipitate with ferric chloride solution.
D. Test of Calcium.
3. Residue on Ignition 18.5 10.0 % – 20.0 %
4. Chloride And Sulphate Below 20.0 Chloride : NMT 0.36%

Sulfate : NMT 1.0 %

5. Alkalinity Complies No red colour develops with phelolphthalein
6. Loss on drying (%) (Dried at 1050 C for 3 hr) 5.6 NMT 10.0 %

 

REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P.

SPECIFICATION

 

Name of the Product:  Polacrilin Potassium U.S.P. / N.F.

  

No. TESTS SPECIFICATIONS

(U.S.P. 38 / N.F. 33)

1. Identification A. Infrared Absorption.
B. Potassium Test:

Aqueous phase of Sample solution A (1 gm  with 10 ml of water) doesn’t meet with the requirements of Potassium test while Aqueous phase of Sample solution B (1 gm  with 10 ml of 0.1 N hydrochloric acid) meets with the requirements of Potassium test

2. Assay (Content of Potassium) (%) 20.6% – 25.1%
3. Heavy metals (µg/g) NMT 20 µg/g
4. Iron (%) NMT 0.01%
5. Limit of Sodium (%) NMT 0.20%
6. Powder Fineness:

Retained on 100 No. sieve (%)

Retained on 200 No. sieve (%)

 

NMT 1.0%

NMT 30.0%

7. Loss on drying (%) (at 105°C for 6 hr) NMT 10.0%

SPECIFICATION

 

Name of the Product: Sodium Starch Glycolate (Type-A) U.S.P. / N.F.

 

No. TESTS SPECIFICATIONS  

(U.S.P. 38 / N.F. 33)                   

1. Identification A. IR Spectrum of Test specimen should complies with IR Spectrum of Reference Standard.
B.  Gives blue to violet color by addition of Iodine and Potassium iodide to acidified solution of sample.
C. A dense precipitate is formed with Potassium pyroantimonate solution.
D. Intense yellow colour to nonluminous flame.
2. Assay

(On dried basis) (%)

2.8 to 4.2
3. Sodium chloride (%) NMT 7.0%
4. Sodium Glycolate (%) NMT 2.0%
5. Heavy metals (ppm) NMT 20 ppm
6. Iron (%) NMT 0.002%
7. Microbial limits:

A.  Salmonella species

B.  Escherichia coli

 

Absent

Absent

8. pH (1g in 30 ml water) 5.5 to 7.5
9. Loss on drying.

(Dry at 1300 C) (%)

NMT 10.0%

 

TYPICAL CERTIFICATE OF ANALYSIS

 

Client Name: XYZ

Name of the Product: Sodium Starch Glycolate (Type A) U.S.P. / N.F.

Mfg. dt.: MAR 2018                                                                   Batch No.: 05008/18

Exp. dt.: FEB 2023                                                                     Quantity: 25 kg

 

No. TESTS RESULTS SPECIFICATIONS

(U.S.P. 38 /N.F. 33)

1. Description White or almost white, fine free-flowing powder, hygroscopic —-
2. Identification Complies with tests A, B, C & D. A. IR Spectrum of Test specimen should complies with IR Spectrum of Reference Standard.
B.  Gives blue to violet color by addition of Iodine and Potassium iodide to acidified solution of sample.
C. A dense precipitate is formed with Potassium pyroantimonate solution.
D. Intense yellow colour to nonluminous flame.
3. Assay

(On dried basis) (%)

3.5 2.8 to 4.2
4. Sodium chloride (%) Below 7.0 NMT 7.0%
5. Sodium Glycolate (%) Below 2.0 NMT 2.0%
6. Heavy metals (ppm) Below 20 NMT 20 ppm
7. Iron (%) Below 0.002 NMT 0.002%
8. Microbial limits:

A.  Salmonella species

B.  Escherichia coli

 

Absent

Absent

 

Absent

Absent

9. pH (1g in 30 ml water) 7.0 5.5 to 7.5
10. Loss on drying.

(Dry at 1300 C) (%)

4.5 NMT 10.0%

 

REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P.

SPECIFICATION

 

Name of the Product: Sodium Starch Glycolate (Type-B) U.S.P. / N.F.

 

No. TESTS SPECIFICATIONS  

(U.S.P. 38 / N.F. 33)                   

1. Identification A. IR Spectrum of Test specimen should complies with IR Spectrum of Reference Standard.
B.  Gives blue to violet color by addition of Iodine and Potassium iodide to acidified solution of sample.
C. A dense precipitate is formed with Potassium pyroantimonate solution.
D. Intense yellow colour to nonluminous flame.
2. Assay

(On dried basis) (%)

2.0 to 3.4
3. Sodium chloride (%) NMT 7.0%
4. Sodium Glycolate (%) NMT 2.0%
5. Heavy metals (ppm) NMT 20 ppm
6. Iron (%) NMT 0.002%
7. Microbial limits:

A.  Salmonella species

B.  Escherichia coli

 

Absent

Absent

8. pH (1g in 30 ml water) 3.0 to 5.0
9. Loss on drying.

(Dry at 1300 C) (%)

NMT 10.0%

 

 

TYPICAL CERTIFICATE OF ANALYSIS

 

Client Name: XYZ

Name of the Product: Sodium Starch Glycolate (Type B) U.S.P. / N.F.

Mfg. dt.: MAR 2018                                                                   Batch No.: 05009/18

Exp. dt.: FEB 2023                                                                     Quantity: 25 kg

 

No. TESTS RESULTS SPECIFICATIONS

(U.S.P. 38 /N.F. 33)

1. Description White or almost white, fine free-flowing powder, hygroscopic —-
2. Identification Complies with tests A, B, C & D. A. IR Spectrum of Test specimen should complies with IR Spectrum of Reference Standard.
B.  Gives blue to violet color by addition of Iodine and Potassium iodide to acidified solution of sample.
C. A dense precipitate is formed with Potassium pyroantimonate solution.
D. Intense yellow colour to nonluminous flame.
3. Assay

(On dried basis) (%)

2.8 2.0 to 3.4
4. Sodium chloride (%) Below 7.0 NMT 7.0%
5. Sodium Glycolate (%) Below 2.0 NMT 2.0%
6. Heavy metals (ppm) Below 20 NMT 20 ppm
7. Iron (%) Below 0.002 NMT 0.002%
8. Microbial limits:

A.  Salmonella species

B.  Escherichia coli

 

Absent

Absent

 

Absent

Absent

9. pH (1g in 30 ml water) 4.5 3.0 to 5.0
10. Loss on drying.

(Dry at 1300 C) (%)

5.5 NMT 10.0%

 

REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P.

Uses of Product:

Used as pharmaceutical excipient, texturizer, anti-caking agent, fat substitute, emulsifier, bulking agent.

 

Technical Details
CAS No 9004-34-6
Mol. Formula N/A
Mol. Weigh N/A

 

Specification
Identification:

A. Reaction with iodinated zinc chloride solution

B. Degree of polymerization

 

– Violet-blue color

 

– Not more than 350

Microbial limit:

A. TAMC

B. TYMC

C. Staphylococcus aureus

D. Pseudomonas aeruginosa

E. Escherichia coli

 

– 1000 CFU/gm

– 100 CFU/gm

– Absent

– Absent

– Absent

Conductivity Not more than 75 µS/cm of that of water
pH (of supernant of suspension) 5.0 – 7.5
Loss on drying (105 0C, 3 hr) Not more than 7.0 % w/w
Residue on ignition Not more than 0.1 % w/w
Water soluble substances Not more than 0.25 % w/w
Ether soluble substances Not more than 0.05 % w/w
Heavy metal Not more than 0.001 % w/w
Organic volatile impurities To comply with test of relevant pharmacopoeia
Residual solvent To comply with test of relevant pharmacopoeia

TYPICAL CERTIFICATE OF ANALYSIS

 

Client Name: XYZ

Name of the Product: Disodium Edetate Dihydrate

 

Mfg. dt.: FEB 2018                                                             Batch No.: DSE/D/1718/001

Exp. dt.: JAN 2023                                                             A.R. No.: QC/180203/27

Release dt.: 03/02/2018                                                    Analysis dt.: 03/02/2018

IN-HOUSE TEST CARRIED OUT

 

Sr. No Tests Specifications Results
1 Description A white, crystalline powder; odorless Conforms to the specification
2 Solubility Soluble in water; practically insoluble in ethanol 95 % Conforms to the specification
3 Identification A Infrared absorption spectrophotometry  

Passes the test

Identification B No precipitate should be produced No precipitate is produced
Identification C No precipitate should be produced No precipitate is produced
Identification D Gives the reactions of sodium salts Passes the test
4 Appearance of solution 5.0 % w/v solution Clear and colorless Clear and colorless
5 pH of 5.0 % w/v solution 4.0 to 5.5 5.41
6 Impurity A As per the test Passes the test
7 Heavy metals Not more than 20 PPM Passes the test
8 Iron Not more than 80 PPM Passes the test
9 Loss on drying Between 8.7 and 11.4 % 9.53 %
10 Assay (on dry basis) Between 98.5 and 101 % 99.17 %

 

Remark: The product complies with the in-house standards of quality.

Uses of Product:

  • Mainly used as food additive and preservative
  • The anticoagulant in blood transfusions
  • Used to relieve discomfort in urinary tract infections
  • It also works as buffering agent in food and acidity regulator as antacid
  • Used as a sequestrant – to improve the quality and stability of the food products
  • Used as an emulsifier – to stabilize processed foods like cheese

 

Technical Details
CAS No 6132-04-3
Mol. Formula C6H5Na3O7•2H2O
Mol. Weigh 294.1
Category Anticoagulant

 

Specification
Description White or almost white, crystalline powder or granular crystals
Solubility Freely soluble in water and very soluble in boiling water; insoluble in alcohol and in ether
Appearance of solution 10% aqueous solution is clear and colourless
Acidity or Alkalinity Passes as per the Pharmacopoeia
Chlorides Passes as per Pharmacopoeia
Sulphates Passes as per Pharmacopoeia
Heavy metals Passes as per Pharmacopoeia
Arsenic Passes as per Pharmacopoeia
Oxalates Passes as per Pharmacopoeia
Readily carbonisable substances Passes as per Pharmacopoeia
Tartrate Passes as per Pharmacopoeia
Pyrogens Passes as per Pharmacopoeia
Water Between 11.0 and 13.0 % w/w
Assay Between 99.0 and 100.5 % w/w

SPECIFICATION

 

Name of the Product:  MICOAT L-100 [METHACRYLIC ACID COPOLYMER U.S.P. (TYPE A) (L-100)]

 

No. TESTS SPECIFICATIONS  

(U.S.P. 38 / N.F. 33)                   

1. Description and Solubility White powder having a faint characteristic odor.

Freely soluble in ethanol, methanol, isopropanol, acetone. Soluble in dilute alkali. Insoluble in dilute acids.

 

2.

Identification A.             Infrared Absorption
B.              Assay
3. Assay [ Methacrylic Acid Units, Dried Basis (%) ] 46.0 to 50.6
4. Residue on Ignition (%) NMT 0.1
5. Heavy Metals (µg/g) NMT 20
6. Limit of Monomers (%) NMT 0.05
7. Viscosity – Rotational Method (mPa.s) 60 to 120
8. Loss on Drying (%) NMT 5.0
9. Organic Volatile Impurities Nil

 

 

TYPICAL CERTIFICATE OF ANALYSIS

 

Client Name: XYZ

Name of the Product: MICOAT L-100 [METHACRYLIC ACID COPOLYMER U.S.P. (TYPE A) (L-100)]

Mfg. dt.: MAR 2018                                                                  Batch No.: MAC-01/0318

Exp. dt.: FEB 2023                                                                    Quantity: 50 gm

 

No. TESTS RESULTS SPECIFICATIONS

(U.S.P. 38 /N.F. 33)

1. Description and Solubility White powder having a faint characteristic odor.

Freely soluble in ethanol, methanol, isopropanol, acetone. Soluble in dilute alkali. Insoluble in dilute acids.

White powder having a faint characteristic odor.

Freely soluble in ethanol, methanol, isopropanol, acetone. Soluble in dilute alkali. Insoluble in dilute acids.

2. Identification Complies with tests A, & B. C.   Infrared Absorption
D.   Assay
3. Assay [ Methacrylic Acid Units, Dried Basis (%) ] 48.7 46.0 to 50.6
4. Residue on Ignition (%) Below 0.1 NMT 0.1
5. Heavy Metals (µg/g) Below 20 NMT 20
6. Limit of Monomers (%) Below 0.05 NMT 0.05
7. Viscosity – Rotational Method (mPa.s) 109 60 to 120
8. Loss on Drying (%) 2.1 NMT 5.0
9. Organic Volatile Impurities Nil Nil

 

REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P.

SPECIFICATION

 

Name of the Product:  MICOAT S-100 [METHACRYLIC ACID COPOLYMER U.S.P. (TYPE B) (S-100)]

 

No. TESTS SPECIFICATIONS  

(U.S.P. 38 / N.F. 33)                   

1. Description and Solubility White powder having a faint characteristic odor.

Freely soluble in ethanol, methanol, isopropanol, acetone. Soluble in dilute alkali. Insoluble in dilute acids.

 

2.

Identification A.   Infrared Absorption
B.    Assay
3. Assay [ Methacrylic Acid Units, Dried Basis (%) ] 27.6 to 30.7
4. Residue on Ignition (%) NMT 0.1
5. Heavy Metals (µg/g) NMT 20
6. Limit of Monomers (%) NMT 0.05
7. Viscosity – Rotational Method (mPa.s) 50 to 200
8. Loss on Drying (%) NMT 5.0
9. Organic Volatile Impurities Nil

SPECIFICATION

 

Name of the Product: MICOAT L-30 D [METHACRYLIC ACID COPOLYMER U.S.P. (TYPE C) (L-30 D)]

 

No. TESTS SPECIFICATIONS  

(U.S.P. 38 / N.F. 33)                   

1. Description and Solubility White colored liquid of low viscosity, miscible with water in all proportions
2. Identification A.             Infrared Absorption: Matches the Infrared spectrum of working standard
B.              Film forming capability:   To form a clear film
3. pH  2.0 to 3.0
4. Loss on drying (1100C; 6 hrs) (%) 68.5 to 71.5
5. Residue on Ignition (%) Maximum 0.2
6. Limit of Heavy Metals (ppm) Maximum 20
7. Limit of monomers (A+B) (ppm) Maximum 100
8. Viscosity (cps) Maximum 15
9. Coagulum content (%) Maximum 1.0
10. Assay on dried basis (%) 46.0 to 50.6

 

 

TYPICAL CERTIFICATE OF ANALYSIS

 

Client Name: XYZ

Name of the Product  : MICOAT L-30 D [METHACRYLIC ACID COPOLYMER U.S.P. (TYPE C) (L-30 D)] 

Mfg. dt.: MAR 2018                                                                   Batch No.: MAC-03/0318

Exp. dt.: FEB 2023                                                                     Quantity: 50 Kg

 

No. TESTS RESULTS SPECIFICATIONS  

(U.S.P. 38 / N.F. 33)

1. Description and Solubility White colored liquid of low viscosity, miscible with water in all proportions White colored liquid of low viscosity, miscible with water in all proportions
2. Identification Complies with tests A, & B. C.   Infrared Absorption: Matches the Infrared spectrum of working standard
D.   Film forming capability:   To form a clear film
3. pH 2.61  2.0 to 3.0
4. Loss on drying (1100C; 6 hrs) (%) 69.5% 68.5 to 71.5
5. Residue on Ignition (%) 0.04 Maximum 0.2
6. Limit of Heavy Metals (ppm) Below 20 Maximum 20
7. Limit of monomers (A+B) (ppm) Below 100 Maximum 100
8. Viscosity (cps) 5.1 Maximum 15
9. Coagulum content (%) Below 1 Maximum 1.0
10. Assay on dried basis (%) 49.1 46.0 to 50.6

 

REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P.

SPECIFICATION

                                                                                                                                              

Name of the Product: Alginic Acid U.S.P. / N.F.

 

No. TESTS SPECIFICATIONS

(U.S.P. 38 / N.F. 33)

1 Description A white to yellowish-brown, amorphous powder.
2 Solubility Very slightly soluble or practically insoluble in ethanol, practically insoluble in organic solvent, soluble in alkali hydroxides.
3. Identification A. voluminous, gelatinous precipitate with calcium chloride solution
B. Heavy, gelatinous precipitate with 4N sulphuric acid.
C. Deeper bluish hue of upper layer with alcoholic 1,3-naphthalenediol & isopropyl ether.
4. Arsenic (ppm) Maximum 3.0
5. Lead ( ppm) Maximum 10.0
6. Heavy metal (ppm) Maximum 40.0
7. Microbial contamination:

A) TAMC (CFU/g)

B) Salmonella species

C) Escherichia coli

 

Maximum 200

Absent

Absent

8. pH (3% w/v  in water) 1.5 to 3.5
9. Loss on drying (%) Maximum 15.0
10. Total Ash (%) Maximum 4.0
11. Acid value Minimum 230

 

 

TYPICAL CERTIFICATE OF ANALYSIS

 

Client Name: XYZ

Name of the Product: Alginic Acid U.S.P. / N.F.

 

Mfg. dt.: MAR 2018                                                                    Batch No.: 11002/18

Exp. dt.: FEB 2023                                                                      Quantity:  25 kg

 

No. TESTS RESULT SPECIFICATIONS  

(U.S.P.38 / N.F.33)                  

1. Appearance A white to yellowish-brown, amorphous powder. ______
2. Solubility Very slightly soluble or practically insoluble in ethanol, practically insoluble in organic solvent, soluble in alkali hydroxides. ______
3. Identification Complies with Test A, B and C. A. voluminous, gelatinous precipitate with calcium chloride solution
B. Heavy, gelatinous precipitate with 4N sulphuric acid.
C. voluminous, gelatinous precipitate with calcium chloride solution
4. Arsenic (ppm) Below 3.0 Maximum 3.0
5. Lead (ppm) Below 10 Maximum 10.0
6. Heavy metal (ppm) Below 40 Maximum 40.0
7. Microbial contamination:

A) TAMC (CFU/g)

B) Salmonella species

C) Escherichia coli

 

Below 200

Absent

Absent

 

Maximum 200

Absent

Absent

8. pH (3% w/v in water) 2.8 1.5 to 3.5
9. Loss on drying (%) 5.6 Maximum 15.0
10. Total Ash (%) 2.6 Maximum 4.0
11. Acid value 254 Minimum 230

 

REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P./N.F.

SPECIFICATION

                                                                                                                                              

Name of the Product: Sodium Alginate U.S.P. / N.F.

 

No. TESTS SPECIFICATIONS

(U.S.P. 38 / N.F. 33)

1. Appearance White or pale yellowish-brown powder.
2. Solubility Soluble in water, practically insoluble in ethanol.
3. Identification A. Voluminous, gelatinous precipitate formed with calcium chloride solution.
B. Heavy, gelatinous precipitate formed with dilute sulfuric acid.
4. Assay (%) 90.8 to 106.0
5. Arsenic (ppm) Maximum 1.5
6. Lead (ppm) Maximum 10
7. Heavy metals (ppm) Maximum 40
8. Microbial limit:

A. Total bacterial count (CFU/g)

B. Salmonella species

C. Escherichia coli

 

Maximum 200

Absent

Absent

9. Loss on drying (%) Maximum 15.0
10. Total ash (%) (On dried basis) 18.0 to 27.0

 

 

TYPICAL CERTIFICATE OF ANALYSIS

 

Client Name: XYZ

Name of the Product: Sodium Alginate U.S.P. / N.F.

 

Mfg. dt.: MAR 2018                                                                      Batch No.: 06003/18

Exp. dt.: FEB 2023                                                                        Quantity:  kg

 

No. TESTS RESULT SPECIFICATIONS  

(U.S.P.38 / N.F.33)                  

1. Appearance White or pale yellowish-brown powder. ______
2. Solubility Soluble in water, practically insoluble in ethanol. ______
3. Identification Complies with Test A and B. A. Voluminous, gelatinous precipitate formed with calcium chloride solution.
B. Heavy, gelatinous precipitate formed with dilute sulfuric acid.
4. Assay (%) 99.8 90.8 to 106.0
5. Arsenic (ppm) Below 1.5 Maximum 1.5
6. Lead (ppm) Below 10 Maximum 10
7. Heavy metals (ppm) Below 40 Maximum 40
8. Microbial limit:

A. Total bacterial count (CFU/g)

B. Salmonella species

C. Escherichia coli

 

Below 200

Absent

Absent

 

Maximum 200

Absent

Absent

9. Loss on drying (%) 5.6 Maximum 15.0
10. Total ash (%) (On dried basis) 22.3 18.0 to 27.0

 

 REMARK: – This is to certify that the product complies with the prescribed standards of quality as per U.S.P./N.F.

Uses of Product:

Used as a pharmaceutical excipient (lubricant) and food additive.

 

Technical Details
CAS No 4070-80-8
Mol. Formula C22H39NaO4
Mol. Weigh 390.54

 

Specification
Identification (IR Spectrum) To comply
Water by KF Not more than 5.0 % w/w
Lead Not more than 0.001 % w/w
Heavy metals Not more than 0.002 % w/w
Saponification value (on anhydrous basis) 142.2 – 146.0
Limit of sodium stearyl maleate and stearyl alcohol To comply with test of Pharmacopoeia
Organic volatile impurities To comply with test of relevant Pharmacopoeia
Residual solvents To comply with test of relevant Pharmacopoeia
Assay (on anhydrous basis) 99.0 % w/w – 101.5 % w/w