Aminopentamide Sulfate Injection
»Aminopentamide Sulfate Injection is a sterile solution of Aminopentamide Sulfate in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of aminopentamide sulfate (C19H24N2O·H2SO4).
Packaging and storage— Preserve in tight,single-dose or multiple-dose Containers for Injections,as described under Injections á1ñ.Store at controlled room temperature.
Labeling— Label Injection to indicate that it is for veterinary use only.
Identification— Transfer 10mLof the Injection to a separator,add sodium hydroxide TSuntil alkaline to litmus,and extract with 25mLof chloroform.Transfer a few drops of the chloroform extract to a KRS-5plate,and allow to dry.Record the IRabsorption spectrum by the attenuated total reflectance technique (see Spectrophotometry and Light-Scattering á851ñ).The spectrum thus obtained exhibits maxima only at the same wavelengths as that of a similar preparation of USP Aminopentamide Sulfate RS,concomitantly measured.
Bacterial endotoxins á85ñ— It contains not more than 25USP Endotoxin Units per mg of aminopentamide sulfate.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: between 2.5and 4.5.
Other requirements— It meets the requirements under Injections á1ñ.
Assay—
Mobile phase— Transfer 14.4g of sodium lauryl sulfate to a 500-mLvolumetric flask,add 100mLof glacial acetic acid,dilute with water to volume,mix,and pass through a filter having a 0.5-µm or finer porosity.Transfer 50mLof this solution to a 1000-mLvolumetric flask,add 350mLof methanol and 350mLof acetonitrile,dilute with water to volume,and mix.Filter and degas before use.Make adjustments if necessary (see System Suitabilityunder Chromatography á621ñ).
Standard preparation— Quantitatively dissolve an accurately weighed quantity of USP Aminopentamide Sulfate RSin water to obtain a solution having a known concentration equivalent to the labeled concentration of aminopentamide sulfate in the Injection.
Assay preparation— Use the undiluted Injection.
Chromatographic system (see Chromatography á621ñ)— The liquid chromatograph is equipped with a 254-nm detector and a 3.9-mm ×30-cm column that contains packing L1and is maintained at a constant temperature of about 40.The flow rate is about 1mLper minute.Chromatograph the Standard preparation,and record the peak responses as directed for Procedure:the tailing factor is not more than 2.5;and the relative standard deviation for replicate injections is not more than 2%.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the areas for the major peaks.Calculate the quantity,in mg,of aminopentamide sulfate (C19H24N2O·H2SO4)in each mLof the Injection taken by the formula:
C(rU/rS),
in which Cis the concentration,in mg per mL,of USP Aminopentamide Sulfate RSin the Standard preparation;and rUand rSare the aminopentamide peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 127
Pharmacopeial Forum:Volume No.27(1)Page 1748
Phone Number:1-301-816-8178