Packaging and storage
Preserve in tight containers. No storage requirements specified.
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.
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
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.
A 1-g portion shows no more chloride than corresponds to 0.5 mL of 0.020 N hydrochloric acid (0.035%).
A 2-g portion shows no more sulfate than corresponds to 0.5 mL of 0.020 N sulfuric acid (0.024%).
: Catherine Sheehan, B.Sc., Scientist
Expert Committee : (EM105) Excipient Monographs 1
USP29NF24 Page 3345
: Volume No. 31(2) Page 496
Phone Number : 1-301-816-8262