Biperiden Lactate Injection
C21H29NO·C3H6O3 401.54

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

a-5-Norbornen-2-yl-a-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 95.0percent and not more than 105.0percent of the labeled amount of C21H29NO·C3H6O3.
Packaging and storage— Preserve in single-dose containers,preferably of Type Iglass,protected from light.
Identification— Using a volume of Injection,equivalent to about 50mg of biperiden lactate,and using a solution of 50mg of USP Biperiden RSin 25mLof 0.01Nhydrochloric acid,proceed as directed under Identification—Organic Nitrogenous Bases á181ñ,beginning with “Transfer the liquid to a separator”:the Injection meets the requirements of the test.
Bacterial endotoxins á85ñ— It contains not more than 83.3USP Endotoxin Units per mg of biperiden lactate.
pHá791ñ: between 4.8and 5.8.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Phosphate buffer–bromocresol purple solution— Prepare as directed in the Assayunder Biperiden Hydrochloride Tablets.
Standard preparation— Transfer about 80mg of USP Biperiden RS,accurately weighed,to a 100-mLvolumetric flask,add methanol to volume,and mix.Transfer 5.0mLof this solution to a second 100-mLvolumetric flask,add 25mLof water,dilute with methanol to volume,and mix to obtain a Standard preparationhaving a known concentration of about 40µg per mL.
Assay preparation— Transfer an accurately measured volume of Injection,equivalent to about 5mg of biperiden lactate,to a 100-mLvolumetric flask,add 25mLof water,dilute with methanol to volume,and mix.
Procedure— Proceed as directed in the Assayunder Biperiden Hydrochloride Tablets.Calculate the quantity,in mg,of C21H29NO·C3H6O3in each mLof the Injection taken by the formula:
(401.55/311.47)(0.1C/V)(AU/AS),
in which 401.55and 311.47are the molecular weights of biperiden lactate and biperiden,respectively;Cis the concentration,in µg per mL,of USP Biperiden RSin the Standard preparation;Vis the volume,in mL,of Injection taken;and AUand ASare the absorbances of the solutions from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Salvador C.Salado,M.S.,Scientist and Latin American Liaison
Expert Committee:(PA3)Pharmaceutical Analysis 3
USP28–NF23Page 262
Phone Number:1-301-816-8165