Sodium Lactate Injection
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Propanoic acid,2-hydroxy-,monosodium salt.
Sodium lactate [72-17-3].
»Sodium Lactate Injection is sterile Sodium Lactate Solution in Water for Injection,or a sterile solution of Lactic Acid in Water for Injection prepared with the aid of Sodium Hydroxide.It contains not less than 95.0percent and not more than 110.0percent of the labeled amount of C3H5NaO3.
Packaging and storage—
Preserve in single-dose glass or plastic containers.Glass containers are preferably of Type Ior Type IIglass.
Labeling—
The label states the total osmolar concentration in mOsmol per liter.Where the contents are less than 100mL,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 2mLof Injection on 5mLof a 1in 100solution of catechol in sulfuric acid:a deep red color is produced at the zone of contact.
B:
To 2mLof Injection add 5mLof 2Nsulfuric acid and 2mLof potassium permanganate TS,and heat:the odor of acetaldehyde is evolved.
Bacterial endotoxins á85ñ—
It contains not more than 2.0USP Endotoxin Units per mEq.
pHá791ñ:
between 6.0and 7.3,the Injection being diluted with water,if necessary,to approximately 0.16M(20mg per mL).
Particulate matter á788ñ:
meets the requirements under small-volume injections.
Heavy metals á231ñ—
Evaporate a volume of Injection,equivalent to 2.0g of sodium lactate,to 5mL,and dilute with 1Nacetic acid to 25mL:the limit is 0.001%.
Other requirements—
It meets the requirements under Injections á1ñ.
Assay—
Pipet into a small beaker a volume of Injection,equivalent to about 300mg of sodium lactate,and evaporate to dryness.Add to the residue 60mLof a 1in 5mixture of acetic anhydride in glacial acetic acid,and stir until the residue is completely dissolved.Titrate with 0.1Nperchloric acid VS,determining the endpoint potentiometrically.Perform a blank determination,and make any necessary correction.Each mLof 0.1Nperchloric acid is equivalent to 11.21mg of C3H5NaO3.
Auxiliary Information—
Staff Liaison:Karen A Russo,Ph.D.,Scientist
Expert Committee:(PA1)Pharmaceutical Analysis 1
USP28–NF23Page 1787
Phone Number:1-301-816-8379