Packaging and storage
Preserve in tight,light-resistant,single-dose or multiple-dose
Containers for Injectionsas described under
Injections á1ñ,preferably of Type Iglass,and store at controlled room temperature.
Labeling
Label it to indicate that it is for veterinary use only.
USP Reference standards á11ñ
USP Acepromazine Maleate RS.
NOTEThroughout the following procedures,protect test or assay specimens,the Reference Standard,and solutions containing them,by conducting the procedures without delay,under subdued light,or using low-actinic glassware.
Identification
A:
Infrared Absorption á197Kñ
Test specimen
To a volume of Injection,equivalent to about 20mg of acepromazine maleate,add 2mLof water and 3mLof 2Nsodium hydroxide,and extract with two 5-mLportions 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 preparationcorresponds to that in the chromatogram of the
Standard preparation,as obtained in the
Assay.
Assay
Mobile phase,Standard preparation,andChromatographic system
Proceed as directed in the
Assayunder
Acepromazine Maleate.
Assay preparation
Transfer an accurately measured volume of Injection,equivalent to about 100mg of acepromazine maleate (C19H22N2OS·C4H4O4),to a 100-mLvolumetric flask,dilute with 0.05Nhydrochloric acid to volume,and mix.Transfer 5.0mLof this solution to a 50-mLvolumetric flask,dilute with water to volume,and mix.
Procedure
Proceed as directed for
Procedurein the
Assayunder
Acepromazine Maleate.Calculate the quantity,in mg,of acepromazine maleate (C
19H
22N
2OS·C
4H
4O
4)in each mLof the Injection taken by the formula:
1000(C/V)(rU/rS),
in which
Vis the volume,in mL,of Injection taken;and the other terms are as defined therein.