Oxytétracycline Hcl

Oxytétracycline HCL Spécifications de haute qualité \ n

Item	Index					Result
Description	Yellow crystalline powder,hygroscopic, freely soluble in water,Solution in water become turbid on standing.Owing to the precipitation of oxytetracycline					Conform
Identification	a) TLC testformed					Conform
	b) Color reaction with sulfuric acid					Conform
	c) Chloride reaction with silver nitrate					Conform
Ph	2.3-2.9					2.49
Specific optical rotation	Between –188° and –200°					-193º
Absorbance: (353nm,E1%, 1cm)	Between 270 and 290					275
Light absorbing impurity:	a) The absorbance at 430nm should not be greater than 0.50					less than10
	b) The absorbance at 490nm should not be greater than 0.20
Related substances:	a) 4-epioxytetracycline≤0.5%					less than0.05
	b) Tetracycline:≤2.0%
	c) Total mixture of α,ß–apo-oxytetracycline ≤2.0%
	d) Peak on the tail of the main peak:2.0%
Heavy metals	Not more than 50ppm					less than1
Suphated ash	Not more than 0.5%					0.01
Water	Not more than 2.0%					30.62
Endotoxin	Not more than 0.4I.E./mg					12.09
Assay	Between 95.0% and 100.5% based on anhydrous substance					less than10

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Groupes de Produits : Matières premières pharmaceutiques