Product Portfolio with regulatory compliance

Meloxicam

Bulk Active : Meloxicam
MOLECULAR FORMULA : C14H13N3O4S2
MOLECULAR WEIGHT : 351.4
Pharmacologic Activity : NSAID
CAS No : 71125-38-7
Specifications : BP
Regulatory compliance : eDMF(CTD)

TEST USP 36 BP 2013/EP 7.4
     
CHARACTERS Pale yellow powder. Pale yellow powder.
     
SOLUBILITY Soluble in dimethylformamide; slightly soluble in acetone; very slightly soluble in methanol and in alcohol; practically insoluble in water Practically insoluble in water, soluble in dimethylformamide, very slightly soluble in ethanol (96 per cent). It shows polymorphism.
     

IDENTIFICATION
INFRARED ABSORPTION



LIGHT ABSORPTION







Infrared absorption spectrum of sample should
be concordant with the reference spectrum of Meloxicam working reference standard

Infrared absorption spectrophotometry to compare with spectrum obtained with Lidocaine Hcl reference standard




Infrared absorption spectrum of sample should be concordant with the reference spectrum of Meloxicam reference standard






     
RELATED SUBSTANCE
IMP A
IMP B
IMP C
IMP D
UNSPECIFIED
IMPURITIES
TOTAL IMPURITIES

-----
Not more than 0.1%
Not more than 0.1%
Not more than 0.1%
Not more than 0.1%
Not more than 0.3%

Not more than 0.1%
Not more than 0.1%
Not more than 0.05%
Not more than 0.05%
Not more than 0.10%
Not more than 0.3%
     
LOSS ON DRYING Not more than 0.5% w/w Maximum 0.5% w/w
     
SULPHATED ASH
----- Maximum 0.1% w/w
     
RESIDUE ON IGNITION Not more than 0.1 % w/w -----
     
HEAVY METALS Not more than 10 ppm Maximum 20 ppm
     
ASSAY NLT 99.0% and NMT 100.5% Between 99.0% and 101.0% w/w