Sell FLUOXETINE HCL BP/EP/USP/EP

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SPECIFICATION OF FLUOXETINE HCL(BP/USP/EP)

SR. NO TEST SPECIFICATION
1 Description White or almost White , crystalline powder.
2 Solubility Freely soluble in methanol, sparingly soluble in methylene chloride sparingly soluble in water.
3 Identification 1. IR absorption spectophotometry(2.2.24) . comparision :Fluoxetine Hcl CRS. Examine the substances prepared as discs.
4 Optical Rotation -0.050 to + 0.050
5 PH 4.5 to 6.5
6 Heavy Metal Not More than 0.002
7 Chloride Not Less Than 10 % & Not More Thane 10.5 % w/w
8 Sulphated Ash Not more then 0.1 % w/w
9 Related SubstancesA. by HPLC Impurity A : Not more than 0.24%Impurity B : Not more than 0.27%Impurity C : Not more than 0.94%
10 Water Not more than 0.5 % w/w
11 Assay Not Less Than 99% &Not more thane 101.0%