Amitraz Concentrate for Dip
»Amitraz Concentrate for Dip contains Amitraz in a suitable vehicle.It may contain a suitable stabilizing agent.It contains not less than 90.0percent and not more than 120.0percent of the labeled amount of amitraz (C19H23N3).
Packaging and storage— Preserve in well-closed containers.
Labeling— Label it to indicate that it is for veterinary use only.The label states also that it is to be diluted before use and states the name and quantity of diluent to be used,the directions for dilution,and the conditions for storage of the constituted Dip.
Identification—
A: Proceed as directed in the test for Related compoundsunder Amitraz,except to prepare a test solution by diluting the Concentrate with toluene to obtain a solution containing about 5mg of amitraz per mLand to prepare a Standard solution of USP Amitraz RSin toluene containing 5mg per mL:the RFvalue of the principal spot in the chromatogram obtained from the test solution corresponds to that in the chromatogram obtained from the Standard solution.
B: The retention time of the major peak in the chromatogram of the Reference solutioncorresponds to that in the chromatogram of the Standard preparation,as obtained in the Assay.
Water,Method Iá921ñ: not more than 0.15%,anhydrous pyridine being used in place of methanol in the titration vessel.
Assay—
Internal standard solution,Standard preparation,and Chromatographic system— Proceed as directed in the Assayunder Amitraz.
Assay preparation— Transfer an accurately measured volume of Concentrate,equivalent to about 80mg of amitraz,to a 10-mLvolumetric flask,dilute with Internal standard solutionto volume,and mix.
Reference solution— Transfer an accurately measured volume of Concentrate,equivalent to about 80mg of amitraz,to a 10-mLvolumetric flask,dilute with methyl acetate to volume,and mix.
Procedure— Proceed as directed for Procedurein the Assayunder Amitraz.Calculate the quantity,in mg,of amitraz (C19H23N3)in each mLof the Concentrate taken by the formula:
10(C/V)(RU/RS),
in which Vis the volume,in mL,of Concentrate taken to prepare the Assay preparation;and the other terms are as defined therein.
Auxiliary Information— Staff Liaison:Ian DeVeau,Ph.D.,Senior Scientist
Expert Committee:(VET)Veterinary Drugs
USP28–NF23Page 135
Phone Number:1-301-816-8178