Acepromazine Maleate Injection
» Acepromazine Maleate Injection is a sterile solution of Acepromazine Maleate in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of acepromazine maleate (C19H22N2OS·C4H4O4).
Packaging and storage Preserve in tight, light-resistant, single-dose or multiple-dose Containers for Injections as described under Injections 1, preferably of Type I glass, and store at controlled room temperature.
Labeling Label it to indicate that it is for veterinary use only.
USP Reference standards 11
USP Endotoxin RS
[noteThroughout the following procedures, protect test or assay specimens, the USP Reference Standard, and solutions containing them, by conducting the procedures without delay, under subdued light, or using low-actinic glassware. ]
Test specimen To a volume of Injection, equivalent to about 20 mg of acepromazine maleate, add 2 mL of water and 3 mL of 2 N sodium hydroxide, and extract with two 5-mL portions of cyclohexane. Combine the cyclohexane extracts, and evaporate to dryness under vacuum, using gentle heat, if necessary.
B: The retention time of the major peak for acepromazine in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Bacterial endotoxins 85: not more than 4.5 USP Endotoxin Units per mg of acepromazine maleate.
Sterility 71 It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: between 4.5 and 5.8.
Other requirements It meets the requirements under Injections 1.
Mobile phase, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Acepromazine Maleate.
Assay preparation Transfer an accurately measured volume of Injection, equivalent to about 100 mg of acepromazine maleate (C19H22N2OS·C4H4O4), to a 100-mL volumetric flask, dilute with 0.05 N hydrochloric acid to volume, and mix. Transfer 5.0 mL of this solution to a 50-mL volumetric flask, dilute with water to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Acepromazine Maleate. Calculate the quantity, in mg, of acepromazine maleate (C19H22N2OS·C4H4O4) in each mL of the Injection taken by the formula:
1000(C/V)(rU / rS)in which V is the volume, in mL, of Injection taken; and the other terms are as defined therein.
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USP35NF30 Page 2029Pharmacopeial Forum: Volume No. 30(4) Page 1161