Packaging and storage—
Preserve in single-dose glass or plastic containers. Glass containers are preferably of Type I or Type II glass.
Labeling—
The label states the total osmolar concentration in mOsmol per L. Where the contents are less than 100 mL, or where the label states that the Injection is not for direct injection but is to be diluted before use, the label alternatively may state the total osmolar concentration in mOsmol per mL. The label includes also the warning: “Not for use in the treatment of lactic acidosis.”
Identification—
A:
Overlay 2 mL of Injection on 5 mL of a 1 in 100 solution of catechol in sulfuric acid: a deep red color is produced at the zone of contact.
B:
To 2 mL of Injection add 5 mL of 2 N sulfuric acid and 2 mL of
potassium permanganate TS, and heat: the odor of acetaldehyde is evolved.
pH 
791
:
between 6.0 and 7.3, the Injection being diluted with water, if necessary, to approximately 0.16
M (20 mg per mL).
Heavy metals 231—
Evaporate a volume of Injection, equivalent to 2.0 g of sodium lactate, to 5 mL, and dilute with 1 N acetic acid to 25 mL: the limit is 0.001%.
Other requirements—
It meets the requirements under
Injections 1.
Assay—
Pipet into a small beaker a volume of Injection, equivalent to about 300 mg of sodium lactate, and evaporate to dryness. Add to the residue 60 mL of a 1 in 5 mixture of acetic anhydride in glacial acetic acid, and stir until the residue is completely dissolved. Titrate with 0.1 N perchloric acid VS, determining the endpoint potentiometrically. Perform a blank determination, and make any necessary correction. Each mL of 0.1 N perchloric acid is equivalent to 11.21 mg of C3H5NaO3.
Auxiliary Information—
Staff Liaison :
Daniel K. Bempong, Ph.D., Scientist
Expert Committee : (MDPS05) Monograph Development-Pulmonary and Steroids
USP29–NF24 Page 1984
Pharmacopeial Forum : Volume No. 31(5) Page 1402
Phone Number : 1-301-816-8143
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