Packaging and storage— Preserve in tight containers. No storage requirements specified.

Labeling— Label it to indicate that it is not intended for use in preparations for infants under one year of age, unless it meets the requirement for Clostridium species.

USP Reference standards 11— USP L-Proline RS.

Identification— To a 0.5-mL aliquot of a solution (1 in 20) in a reaction vial add 0.25 mL of formic acid and 1.0 mL of freshly prepared 3% solution of ninhydrin in peroxide-free ethylene glycol monomethyl ether. Cap the reaction vial tightly, shake well, and place in boiling water for 15 minutes. Cool for 5 minutes in a 22 water bath, remove the cap, and add 5.0 mL of 5% aqueous isopropanol solution. The solution shows a purple color similar to, or more intense than, that of a similarly treated 7.5-µg per mL solution of USP L-Proline RS. If necessary, scan the solutions being compared using a suitable spectrophotometer against a water blank. The two solutions each exhibit a maximum at the same wavelength, at about 520 nm. The absorbance of the sample solution should be at least as high as that of the similarly treated 7.5-µg per mL solution of USP L-Proline RS.

Specific gravity 841: between 1.400 and 1.435 at 20.

Refractive index 831: between 1.4900 and 1.4992 at 20.

Microbial limits 61— The total bacterial count does not exceed 1000 cfu per g, the total combined molds and yeasts count does not exceed 100 cfu per g.

Clostridium species— Where it is intended for use in preparations for infants under one year of age, it meets the requirements for absence of Clostridium species in Microbiological Procedures for Absence of Specified Microorganisms—Nutritional and Dietary Supplements 2022.

Water, Method I 921: between 15.0% and 18.6%.

Chloride 221— A 1-g portion shows no more chloride than corresponds to 0.5 mL of 0.020 N hydrochloric acid (0.035%).

Sulfate 221— A 2-g portion shows no more sulfate than corresponds to 0.5 mL of 0.020 N sulfuric acid (0.024%).

Total ash 561: not more than 0.3%.

Residual solvents 467: meets the requirements.

Expert Committee : (EM105) Excipient Monographs 1

USP29–NF24 Page 3345

Phone Number : 1-301-816-8262