BP / USP grado farmacéutico Ciprofloxacin Hcl / Ciprofloxacin Hcl en polvo

Descripción del producto BP / USP grado farmacéutico Ciprofloxacin Hcl / Ciprofloxacin Hcl en polvo. \ n \ n ANÁLISIS SEGÚN USP 34 \ n \ n

Items of Test	Standard	Result of Test
Appearance	White or light yellow crystalline powder	conform
Identification
(a)   IR	IR spectrum of sample corresponds to that of reference standard.	Conform
	The intensity and RF value of the principal band obtained from the test solution corresponds to that obtained from the standard solution.
(b)   TLC	A solution of IIresponds to the tests of chloride	Conform
(c) the reaction of chloride		Conform
Related substances HPLC	Chromatographic purity ≤ 0.2%	0.15%
	Ciprofloxacin ethylenediamine analog ≤ 0.2%	<0.11%
	Unspecified impurity ≤ 0.50%	0.40%
	Total impurities ≤ 0.5%
Ph	3.0-4.5	3.7
Heavy metals	≤20ppm	<20ppm
Fluoroquinolonic acid	≤0.2%	Conform
Sulphated ash	≤0.04%	<0.04%
Water	4.7%-6.7%	5.90%
Residue of ignition	≤0.1%	0.05%
Residual solvent	ethanol ≤ 5000ppm	560ppm
	Isoamyl alcohol≤ 4000ppm	Not found
Assay (HPLC)	98.0%-102%	99.80%

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Grupos de Producto : API humana > Ciprofloxacina Hcl