Packaging and storage
Preserve in tight containers.
Labeling
Label it to indicate whether it is levorotatory or racemic.
Identification
It meets the requirements of the test for
Lactate 191.
Specific rotation 781A:
between
0.05
and +0.05
, for racemic Lactic Acid.
Readily carbonizable substances
Rinse a test tube with
sulfuric acid TS, and allow to drain for 10 minutes. Add 5 mL of
sulfuric acid TS to the test tube, carefully overlay it with 5 mL of Lactic Acid, and maintain the tube at a temperature of 15
: no dark color develops at the interface of the two acids within 15 minutes.
Sugars
To 10 mL of hot alkaline cupric tartrate TS add 5 drops of Lactic Acid: no red precipitate is formed.
Chloride
To 10 mL of a solution (1 in 100) acidified with nitric acid add a few drops of
silver nitrate TS: no opalescence is produced immediately.
Sulfate
To 10 mL of a solution (1 in 100) add 2 drops of hydrochloric acid and 1 mL of
barium chloride TS: no turbidity is produced.
Heavy metals, Method II 231:
0.001%.
Limit of citric, oxalic, phosphoric, or tartaric acid
To 10 mL of a solution (1 in 10) add 40 mL of
calcium hydroxide TS, and boil for 2 minutes: no turbidity is produced.
Assay
To about 2.5 mL of Lactic Acid, accurately weighed in a tared 250-mL flask, add 50.0 mL of 1 N sodium hydroxide VS, and boil the mixture for 20 minutes. Add
phenolphthalein TS, and titrate the excess alkali in the hot solution with 1 N sulfuric acid VS. Perform a blank determination (see
Residual Titrations under
Titrimetry 541). Each mL of 1 N sodium hydroxide is equivalent to 90.08 mg of C
3H
6O
3.
Auxiliary Information
Staff Liaison :
Lawrence Evans, III, Ph.D., Scientist
Expert Committee : (DSN05) Dietary Supplements - Non-Botanicals
USP29NF24 Page 1223
Pharmacopeial Forum : Volume No. 28(6) Page 1817
Phone Number : 1-301-816-8389