Gelatin
(jel' a tin).
DEFINITION
Gelatin is a product obtained by the partial hydrolysis of collagen derived from the skin, white connective tissue, and bones of animals. Gelatin derived from an acid-treated precursor is known as Type A, and Gelatin derived from an alkali-treated precursor is known as Type B.
Gelatin, where being used in the manufacture of capsules, or for the coating of tablets, may be colored with a certified color, may contain NMT 0.15% of sulfur dioxide, and may contain a suitable concentration of sodium lauryl sulfate and suitable antimicrobial agents.
IDENTIFICATION
• A. Procedure
Sample:
1 g
Analysis:
Dissolve the Sample in 100 mL of hot water. To this solution add 20 mL of a mixture of 0.2 M potassium dichromate and 3 N hydrochloric acid (4:1).
Acceptance criteria:
A yellow precipitate is formed.
• B. Procedure
Sample solution:
0.2 mg/mL
Analysis:
Heat until hot, and add tannic acid TS.
Acceptance criteria:
Turbidity is produced.
OTHER COMPONENTS
• Content of Sulfur Dioxide
Sample solution:
Dissolve 20.0 g in 150 mL of hot water in a flask having a round bottom and a long neck, add 5 mL of phosphoric acid and 1 g of sodium bicarbonate, and at once connect the flask with a condenser. [Note—Excessive foaming can be alleviated by the addition of a few drops of a suitable antifoaming agent. ]
Analysis:
Distill 50 mL, receiving the distillate under the surface of 50 mL of 0.1 N iodine. Acidify the distillate with a few drops of hydrochloric acid, add 2 mL of barium chloride TS, and heat on a steam bath until the liquid is nearly colorless.
Acceptance criteria:
The precipitate of barium sulfate, if any, when filtered, washed, and ignited, weighs NMT 3 mg, corresponding to NMT 40 ppm of sulfur dioxide, correction being made for any sulfate that may be present in 50 mL of the 0.1 N iodine.
Gelatin used in the manufacture of capsules or for the coating of tablets yields NMT 109.3 mg of barium sulfate, corresponding to NMT 0.15% of sulfur dioxide.
IMPURITIES
Inorganic Impurities
• Residue on Ignition 
281
281
Sample:
5.0 g
Analysis:
Incinerate without the use of sulfuric acid, but with the addition of 1.5–2.0 g of paraffin to avoid loss due to swelling, then finish ashing in a muffle furnace at 550
for 15–20 h.
for 15–20 h.
Acceptance criteria:
The weight of the residue does not exceed 2.0%.
• Arsenic, Method I 211
211
Solution A:
5 mg/mL of pepsin in 0.1 N hydrochloric acid
Standard solution:
Transfer 3.0 mL of Standard Arsenic Solution to an arsine generator flask, and dilute with Solution A to 52 mL. Add 3 mL of hydrochloric acid and 4 mL of isopropyl alcohol.
Sample solution:
Mix 3.75 g with 40 mL of Solution A in an arsine generator flask. Heat cautiously to a temperature between 65 and 70, and, while maintaining this temperature for 30 min, sonicate the solution for 2 min at each 10-min interval of heating time. Cool, wash down the sides of the generator with Solution A, and dilute with Solution A to 52 mL. Add 3 mL of hydrochloric acid and 4 mL of isopropyl alcohol.
and 70, and, while maintaining this temperature for 30 min, sonicate the solution for 2 min at each 10-min interval of heating time. Cool, wash down the sides of the generator with Solution A, and dilute with Solution A to 52 mL. Add 3 mL of hydrochloric acid and 4 mL of isopropyl alcohol.
Analysis:
Proceed as directed in the chapter, except omit the addition of 20 mL of 7 N sulfuric acid and 1 mL of isopropyl alcohol to the Standard solution and Sample solution.
Acceptance criteria:
The resulting solution from the Sample solution meets the requirements of the test (NMT 0.8 ppm).
• Heavy Metals 231
231
Sample:
Residue obtained in the test for Residue on Ignition
Analysis:
To the Sample add 2 mL of hydrochloric acid and 0.5 mL of nitric acid, and evaporate on a steam bath to dryness. To the residue add 1 mL of 1 N hydrochloric acid and 15 mL of water, and warm for a few min. Filter and wash with water to make the filtrate measure 100 mL. Dilute 8 mL of the solution with water to 25 mL.
Acceptance criteria:
NMT 50 ppm
Organic Impurities
• Procedure: Odor and Water-Insoluble Substances:
A hot solution (1 in 40) is free from any disagreeable odor, and when viewed in a layer 2-cm thick, is only slightly opalescent.
SPECIFIC TESTS
• Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62:
The total bacterial count does not exceed 1000 cfu/g, and the tests for Salmonella species and Escherichia coli are negative.
61 and Tests for Specified Microorganisms 62:
The total bacterial count does not exceed 1000 cfu/g, and the tests for Salmonella species and Escherichia coli are negative.
ADDITIONAL REQUIREMENTS
• Packaging and Storage:
Preserve in well-closed containers in a dry place.
Auxiliary Information—
Please check for your question in the FAQs before contacting USP.
| Topic/Question | Contact | Expert Committee |
|---|---|---|
| Monograph | Robert H. Lafaver, M.S.
Scientific Liaison 1-301-816-8335 |
(EXC2010) Monographs - Excipients |
| 61 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
| 62 |
Radhakrishna S Tirumalai, Ph.D.
Principal Scientific Liaison 1-301-816-8339 |
(GCM2010) General Chapters - Microbiology |
USP35–NF30 Page 1808