Doxycycline HCl

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0 Metric Ton	Negotiable

0 Metric Ton

Negotiable

API

GMP certificate

Item	Standard	Result
Character	Yellow crystalline Powder	Complies
Solubility	Freely soluble in water and in methanol, sparingly soluble in ethanol ( 96 per cent ). It dissolves in solutions of alkali hydroxides and carbonates.	Complies
Identification	a) HPLC	Complies
	b) Sulphurie acid reaction a yellow colour develops	Complies
	c) It gives reaction of chlorides	Complies
PH	2.0-3.0	2.5
Specific Absorbance	At 349 nm E ( 1% ) 300-335 ( anhydrous and ethanol-free substance )	323
Specific Optical Rotation	-120°~-105° ( anhydrous and ethanol-free substance )	-111°
Heavy Metal	≤50ppm	<50ppm
Light-absorbing Impurities	At 490nm≤0.07 ( anhydrous and ethanol-free substance )	0.02
	a) 6-epidoxycycline ≤2.0%	1.9%
	b) metacycline ≤2.0%	0.3%
	c) 4-epidoxycycline ≤ 0.5%	not found
	d) 4-epi-6-epidoxycycline≤ 0.5%	not found
	e) oxytetracycline≤ 0.5%	not found
	f) 2-acety-2-decarbamoyldoxycycline ADOT ≤ 0.5%	0.4%
	g) any other impurity≤ 0.5%	not found
Ethanol	4.3-6.0% ( m/m )	4.7%
Sulphated Ash	≤ 0.4%	0.05%
Water	1.4-2.8%	1.9%
Assay	95.0%-102.0% ( C₂₂H₂₅CIN₂O₈ ) ( anhydrous and ethanol-free substance )	96.90%
Conclusion: This product fulfills EP7.4, BP2010.