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 90.0 percent and not more than 120.0 percent 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.
USP Reference standards 11
A: Proceed as directed in the test for Related compounds under Amitraz, except to prepare a test solution by diluting the Concentrate with toluene to obtain a solution containing about 5 mg of amitraz per mL and to prepare a Standard solution of USP Amitraz RS in toluene containing 5 mg per mL: the RF value 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 solution corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay.
Water, Method I 921: not more than 0.15%, anhydrous pyridine being used in place of methanol in the titration vessel.
Internal standard solution, Standard preparation, and Chromatographic system Proceed as directed in the Assay under Amitraz.
Assay preparation Transfer an accurately measured volume of Concentrate, equivalent to about 80 mg of amitraz, to a 10-mL volumetric flask, dilute with Internal standard solution to volume, and mix.
Reference solution Transfer an accurately measured volume of Concentrate, equivalent to about 80 mg of amitraz, to a 10-mL volumetric flask, dilute with methyl acetate to volume, and mix.
Procedure Proceed as directed for Procedure in the Assay under Amitraz. Calculate the quantity, in mg, of amitraz (C19H23N3) in each mL of the Concentrate taken by the formula:
10(C / V)(RU / RS)in which V is the volume, in mL, of Concentrate taken to prepare the Assay preparation; and the other terms are as defined therein.
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USP35NF30 Page 2183