Biperiden Lactate Injection
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 IdentificationOrganic 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.
Other requirements It meets the requirements under Injections 1.
Phosphate bufferbromocresol 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.
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USP32NF27 Page 1681