» 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 not more than 0.15 percent of sulfur dioxide, and may contain a suitable concentration of sodium lauryl sulfate and suitable antimicrobial agents.
Packaging and storage— Preserve in well-closed containers in a dry place.
A: Dissolve 1 g of Gelatin in 100 mL of hot water. To this solution add about 20 mL of a mixture of 0.2 M potassium dichromate and 3 N hydrochloric acid (4:1): a yellow precipitate is formed.
B: To a hot solution (0.2 mg per mL) add tannic acid TS: turbidity is produced.
Microbial enumeration tests 61 and Tests for specified microorganisms 62 The total bacterial count does not exceed 1000 cfu per g, and the tests for Salmonella species and Escherichia coli are negative.
Residue on ignition 281 Incinerate 5.0 g without the use of sulfuric acid, but with the addition of 1.5 to 2.0 g of paraffin to avoid loss due to swelling, then finish ashing in a muffle furnace at 550 for 15 to 20 hours: the weight of the residue does not exceed 2.0%.
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.
Sulfur dioxide— 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.] 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. The precipitate of barium sulfate, if any, when filtered, washed, and ignited, weighs not more than 3 mg, corresponding to not more than 0.004% 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 not more than 109.3 mg of barium sulfate, corresponding to not more than 0.15% of sulfur dioxide.
Arsenic, Method I 211
Pepsin solution— Dissolve 0.5 g of pepsin in 80 mL of 0.1 N hydrochloric acid, dilute with 0.1 N hydrochloric acid to 100 mL, and mix.
Standard preparation— Transfer 3.0 mL of Standard Arsenic Solution to an arsine generator flask, and dilute with Pepsin solution to 52 mL. Add 3 mL of hydrochloric acid and 4 mL of isopropyl alcohol, and mix.
Test preparation— Mix 3.75 g with 40 mL of Pepsin solution in an arsine generator flask. Heat cautiously to a temperature between 65 and 70, and, while maintaining this temperature for 30 minutes, sonicate the solution for 2 minutes at each 10-minute interval of heating time. Cool, wash down the sides of the generator with Pepsin solution, and dilute with Pepsin solution to 52 mL. Add 3 mL of hydrochloric acid and 4 mL of isopropyl alcohol, and mix.
Procedure— Proceed as directed for Procedure except omit the addition of 20 mL of 7 N sulfuric acid and 1 mL of isopropyl alcohol to the Standard preparation and to the Test preparation. The resulting solution obtained from the Test preparation meets the requirements of the test: the limit is 0.8 ppm.
Heavy metals 231 To the residue obtained in the test for Residue on ignition 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 minutes. Filter, and wash with water to make the filtrate measure 100 mL. Dilute 8 mL of the solution with water to 25 mL: the limit is 0.005%.
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Monograph Kevin T. Moore, Ph.D.
(EM205) Excipient Monographs 2
61 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
62 Radhakrishna S Tirumalai, Ph.D.
Senior Scientist
(MSA05) Microbiology and Sterility Assurance
USP32–NF27 Page 1240