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Biperiden Lactate Injection
C21H29NO·C3H6O3 401.54

1-Piperidinepropanol, -bicyclo[2.2.1]hept-5-en-2-yl--phenyl-, compd. with 2-hydroxypropanoic acid (1:1).

-5-Norbornen-2-yl--phenyl-1-piperidinepropanol lactate (salt) [7085-45-2].
» Biperiden Lactate Injection is a sterile solution of biperiden lactate (C21H29NO·C3H6O3) in Water for Injection, prepared from Biperiden with the aid of Lactic Acid. It contains not less than 95.0 percent and not more than 105.0 percent of the labeled amount of C21H29NO·C3H6O3.
Packaging and storage— Preserve in single-dose containers, preferably of Type I glass, protected from light.
Identification— Using a volume of Injection, equivalent to about 50 mg of biperiden lactate, and using a solution of 50 mg of USP Biperiden RS in 25 mL of 0.01 N hydrochloric acid, proceed as directed under Identification—Organic Nitrogenous Bases 181, beginning with “Transfer the liquid to a separator”: the Injection meets the requirements of the test.
Bacterial endotoxins 85 It contains not more than 83.3 USP Endotoxin Units per mg of biperiden lactate.
pH 791: between 4.8 and 5.8.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1.
Assay—
Phosphate buffer–bromocresol purple solution— Prepare as directed in the Assay under Biperiden Hydrochloride Tablets.
Standard preparation— Transfer about 80 mg of USP Biperiden RS, accurately weighed, to a 100-mL volumetric flask, add methanol to volume, and mix. Transfer 5.0 mL of this solution to a second 100-mL volumetric flask, add 25 mL of water, dilute with methanol to volume, and mix to obtain a Standard preparation having a known concentration of about 40 µg per mL.
Assay preparation— Transfer an accurately measured volume of Injection, equivalent to about 5 mg of biperiden lactate, to a 100-mL volumetric flask, add 25 mL of water, dilute with methanol to volume, and mix.
Procedure— Proceed as directed in the Assay under Biperiden Hydrochloride Tablets. Calculate the quantity, in mg, of C21H29NO·C3H6O3 in each mL of the Injection taken by the formula:
(401.55 / 311.47)(0.1C / V)(AU / AS),
in which 401.55 and 311.47 are the molecular weights of biperiden lactate and biperiden, respectively; C is the concentration, in µg per mL, of USP Biperiden RS in the Standard preparation; V is the volume, in mL, of Injection taken; and AU and AS are the absorbances of the solutions from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Ravi Ravichandran, Ph.D., Senior Scientist
Expert Committee : (MDPP05) Monograph Development-Psychiatrics and Psychoactives
USP29–NF24 Page 285
Phone Number : 1-301-816-8330