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PIROXICAM USP/BP/IP/EP

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TESTS SPECIFICATIONS REFERENCE
 
Description A white or slightly yellow crystalline powder A white or slightly yellow crystalline powder
Piroxicam
 
Inquir Us
Off-white to light tan or light yellow powder; odourless. IP
 
Solubility Practically insoluble in water, soluble in methylene chloride, slightly soluble in ethanol / Slightly soluble in ethanol and in aqueous alkaline solutions; very slightly soluble in water, in dilute acids and in most organic solvents USP/BP/IP/EP
 
Identification A. To comply IR test.
B. To comply light absorption test.
C. To comply TLC test.		 USP/BP/IP/EP
USP/IP
USP/IP
 
Related Substances Impurity – B – Not more than 0.20 %
Individual Impurity– Not more than 0.20 %
Sum of Impurity – Not more than 0.40 %
 BP/EP
 
Heavy Metals Not more than 50 ppm / Not more than 20 ppm USP/IP/BP/EP
 
Loss on Drying Not more than 0.5 % w/w BP/EP
 
Water Not more than 0.5 % w/w USP/IP
 
Sulphated Ash Not more than 0.3% / Not more than 0.1% IP/BP/EP
 
Organic Volatile Impurities To comply as per USP USP
 
Assay (By HPLC) NMT 97.0 % and NMT 103.0 % of Piroxicam, on dried basis. USP/IP
 
Assay (By Titration) NLT 98.5 % and NMT 101.0 % of Piroxicam, on dried basis. BP/EP