Tolnaftate Usp

SR.NOTESTSPECIFICATIONOBSERVATION
1.DescriptionWhite or creamy white, fine powder, having a slight odourCreamy white powder, odourless
2.SolubilityPractically insoluble in water, freely soluble in acetone & chloroform, very slightly soluble in alcoholComplies
3.Identificationa cInfrared absorption (197K)
a cThe UV absorption maxima and minima for the solution prepared for assay should match USP. Tolnaftate reference standard.
a cThe Rf value of sample to match with the Rf value of USP Tolnaftate RS by TLCPositive
Complies

Complies
4.Melting PointBetween 110au C - 113au C112au C
5.Loss on drying Not more than 0.5% w/w0.20% w/w
6.Residue on ignitionNot more than 0.1% w/w0.032% w/w
7.Heavy MetalsNot more than 0.002% (Method II)In limit
8.AssayNLT 98.00 percent & NMT 102.00 percent calculated with respected to the dried substances99.57% w/w