Cetyl Pyridinium Chloride

MELOXICAM BP

MOLECULAR WEIGHT: 351.4

MOLECULAR FORMULA: C₁₄H₁₃N₃O₄S₂

MELOXICAM BP

TEST	BP (Standard grade)	BP (Injectible grade)
DESCRIPTION	A pale yellow powder	A pale yellow powder
SOLUBILITY	Practically insoluble in water, slightly soluble in acetone, soluble in dimethyl formamide; very slightly soluble in ethanol (96%) and in methanol.	Practically insoluble in water, slightly soluble in acetone, soluble in dimethyl formamide; very slightly soluble in ethanol (96%) and in methanol.
IDENTIFICATION	A] The infrared absorption spectrum is concordant with the reference spectrum of Meloxicam. B] light absorption in the range 240 nm to 450 nm of a 0.0015% w/v solution in methanol exhibits a maximum at 354 nm. The absorbance at 354 nm is about 0.8.	A] The infrared absorption spectrum is concordant with the reference spectrum of Meloxicam. B] light absorption in the range 240 nm to 450 nm of a 0.0015% w/v solution in methanol exhibits a maximum at 354 nm. The absorbance at 354 nm is about 0.8.
LOSS ON DRYING	NMT 0.5% of its weight	NMT 0.5% of its weight
CLARITY OF SOLUTION	The solution is clear	The solution is clear
RELATED SUBSTANCE	0.1% of impurity A 0.1% of impurity B 0.05% for impurity C The nominal total content of any such impurities is not greater than 0.3%.	0.1% of impurity A 0.1% of impurity B 0.05% for impurity C The nominal total content of any such impurities is not greater than 0.3%.
HEAVY METALS	Not more than 10ppm	Not more than 10ppm
LOSS ON DRYING	Not more than 0.5%	Not more than 0.5%
SULPHATED ASH	Not more than 0.1%	Not more than 0.1%
ASSAY TITRIMETRY HPLC	99.0% to 100.5% w/w	99.0% to 100.5% w/w 98.0 to 102.0 % w/w
RESIDUAL SOLVENTS a) O-XYLENE b) METHANOL	-----	Not more than 2170 ppm Not more than 3000 ppm
TOTAL AEROBIC MICROBIAL COUNT	-----	Not more than 1000 cfu
BACTERIAL ENDOTOXIN LIMIT	-----	To comply
PARTICLE SIZE:	-----	100% less than 20µ

MELOXICAM EP6.3

MOLECULAR WEIGHT: 351.4

MOLECULAR FORMULA: C₁₄H₁₃N₃O₄S₂

MELOXICAM BP

TEST	EP 6.3 (Standard grade)	EP 6.3 (Injectible grade)
DESCRIPTION	A pale yellow powder	A pale yellow powder
SOLUBILITY	Practically insoluble in water, slightly soluble in acetone, soluble in dimethyl formamide; very slightly soluble in ethanol (96%) and in methanol.	Practically insoluble in water, slightly soluble in acetone, soluble in dimethyl formamide; very slightly soluble in ethanol (96%) and in methanol.
IDENTIFICATION	A] The infrared absorption spectrum is concordant with the reference spectrum of Meloxicam.	A] The infrared absorption spectrum is concordant with the reference spectrum of Meloxicam.
LOSS ON DRYING	NMT 0.5% of its weight	NMT 0.5% of its weight
CLARITY OF SOLUTION	The solution is clear	The solution is clear
RELATED SUBSTANCE	0.1% of impurity A 0.1% of impurity B 0.05% for impurity C The nominal total content of any such impurities is not greater than 0.3%.	0.1% of impurity A 0.1% of impurity B 0.05% for impurity C The nominal total content of any such impurities is not greater than 0.3%.
HEAVY METALS	Not more than 10ppm	Not more than 10ppm
LOSS ON DRYING	Not more than 0.5%	Not more than 0.5%
RELATED SUBSTANCES (BY HPLC) IMPURITY A IMPURITY B IMPURITY C,D IMPURITY E IMPURITY F UNSPECIFIED IMPURITY TOTAL IMPURITY	Not more than 0.1% Not more than 0.1% Not more than 0.05% Not more than 0.10% Not more than 0.3%	Not more than 0.1% Not more than 0.1% Not more than 0.05% Not more than 0.10% Not more than 0.3%
HEAVY METALS	Not more than 20ppm	Not more than 20ppm
LOSS ON DRYING	Not more than 0.5%	Not more than 0.5%
SULPHATED ASH	Not more than 0.1%	Not more than 0.1%
ASSAY TITRIMETRY HPLC	99.0% to 101.0% w/w -----	99.0% to 101.0% w/w 98.0 to 102.0 % w/w
RESIDUAL SOLVENTS a) O-XYLENE b) METHANOL	-----	Not more than 2170 ppm Not more than 3000 ppm
TOTAL AEROBIC MICROBIAL COUNT	-----	Not more than 1000 cfu
BACTERIAL ENDOTOXIN LIMIT	-----	To comply
PARTICLE SIZE:	-----	100% less than 20µ

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