API CIPROFLOXACIN HCL

It is used for urogenital system infection caused by sensitive bacteria, treatment of typhoid bone and joint infection, skin soft tissue infection, sepsis and other systemic infections.

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Description

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Description

Product Name : CIPROFLOXACIN HCL
Appearance : Light White Crystalline Powder
Storage: Cool Dry Place
CAS No. : 86393-32-0
Origin: China

COA

Tests		Acceptance Criteria		Results
Characters	Appearance	Faintly yellowish to light yellow crystalline powder		Faintly yellowish crystalline powder
	Solubility	Sparingly soluble in water; slightly soluble in acetic acid and methanol; very slightly soluble in dehydrated alcohol; practically insoluble in acetone, in acetonitrile, in ethylacetate, in hexane, and in methylene chloride.		/

Identification	(1)IR:Conforms to the spectrum of Ciprofloxacin Hydrochloride RS. (2)HPLC:The retention time of major peak of the Sample solution corresponds to that of the Standard solution,as obtained in the Assay. (3)Responds to the tests for chloride			Confroms

pH	3.0 to 4.5(25mg/ml water)			3.8
Water	4.7% ~6.7%			6.3%
Residue on ignition	≤0.1%			＜0.01%
Heavy metals	≤20ppm			＜20ppm
Sulphates	≤400ppm			＜400ppm
(HPLC)Organic impurities	Ciprofloxacin ethylenediamine analog		≤ 0.2%	0.08%
	Fluoroquinolonic acid		≤ 0.2%	0.05%
	Any other Individual impurity		≤ 0.2%	0.05%
	The sum of all impurities		≤ 0.5%	0.13%
(HPLC)ASSAY	98.0%~102.0% of C₁₇H₁₈FN₃O₃·HCL(On the anhydrous substance)			100.0%
Residual solvents	Ethanol		≤5000ppm	173ppm
	Toluene		≤890ppm	Not detected
Conclusion:	The product above complies with the standard of USP42.

Application

Some of the most common uses of ciprofloxacin HCl include the treatment of urinary tract infections, bacterial prostatitis, and respiratory tract infections such as bronchitis and pneumonia. It is also commonly used to treat skin and soft tissue infections, as well as bone and joint infections.
In addition to these uses, it can also be used to treat more serious infections such as sepsis or meningitis, which are caused by bacteria that may be resistant to other types of antibiotics. It can also be used in conjunction with other antibiotics to treat certain types of infections that are particularly difficult to treat.

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