Product Portfolio with regulatory compliance

Carisoprodol

Bulk Active : Carisoprodol
MOLECULAR FORMULA :C₁₂H₂₄N₂O₄
MOLECULAR WEIGHT : 260.3
Pharmacologic Activity : Skeletal muscle relaxant
CAS No : 78-44-4
Specifications : BP/USP
Regulatory compliance : Under preparation

TEST	USP 36	BP 2013/EP 7.4

CHARACTERS	White crystalline powder having characteristic odor and bitter taste	White or almost white, fine powder

SOLUBILITY	Very slightly soluble in water, freely soluble in acetone, in alcohol and in chloroform	Very slightly soluble in water, freely soluble in acetone, in alcohol and in methylene chloride.

IDENTIFICATION MELTING POINT INFRARED ABSORPTION TEST C TEST D	----- IR spectra concordant with reference sample The retention time of the major peak in the Sample solution corresponds to that in the Standard solution as obtained in the Assay. ------	92 °C to 95 °C. Infrared absorption spectrophotometry Comparison carisoprodol CRS. Examine the chromatograms obtained in the test for related substances. The principal spot in the chromatogram obtained with test solution (b) is similar in position, colour and size to the principal spot in the chromatogram obtained with reference solution (d). An intense blue colour develops

OPTICAL ROTATION	-----	- 0.10° to + 0.10°.

RELATED SUBSTANCE IMP D Carisoprdol related compound A Meprobamate Carisoprodol monocarbamate Any other unknown individual impurity Total impurities	----- 0.1 0.5 0.1 0.1 1.0	0.5 % ----- ----- ----- 0.2% -----

LOSS ON DRYING	NMT 0.5%	NMT 0.5 % w/w

SULPHATED ASH	-----	NMT 0.10%

RESIDUE ON IGNITION	NMT 0.1 per cent,	---------

HEAVY METALS	NMT 10PPM	NMT 10PPM

ASSAY	NLT 98.0% and NMT 102.0% of C₁₂H₂₄N₂O₄ , calculated on the dried basis.	98.0 per cent to 102.0 per cent (dried substance)