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Home > Products > Active Pharmaceutical Ingredients > Enrofloxacin Base Cpv2010 GMP Approved

Enrofloxacin Base Cpv2010 GMP Approved

Payment Type: L/C, D/P

Basic Info

Model No.:  CPV 2010

Product Description



Model NO.: CPV 2010


Classification: API


Appearance: Powder


MOQ: 100kgs


Trademark: SINOCHEM


Specification: CPV2010


HS Code: 2933599090




Efficacy: API


Type: API


Color: White


GMP Approved: Yes


Transport Package: 25kg/Drum


Origin: China


Appearance : Light yellow or light orange yellow crystalline powder .



Solubility : Easily soluble in chlorofonn, sparingly soluble in DMF, slightly soluble in methanol, very slightly soluble in water and sodium hydroxide test solution.



Clarity and color of Solution: The solution should be clear. If the solution is turbid, it's not more thickness than 1 turbidity standard solution. If the solution has color, it's not deeper than yellow 4 or yellow-green 4 standard color solution.



Identification:

A. The retention time of major peak in the chromatogram obtained from sample corresponds to that in the chromatogram obtained from reference standard, as obtained in Assay.

B. Infrared absorption: Infrared spectrum obtained from sample corresponds to the spectrum obtained from reference standard.



Fluoroquinolonic acid: Not more than 0.2%

Melting range: Between 221 'C and 226'C

Loss on drying : Not more than 0.5%

Heavy metals: Not more than 20ppm

Residual on ignition: Not more than 0.2%

Related substance:



Any other single impurity: Not more than 0.3%

Total impurity: Not more than 0.7%

Assay(on the dried basis) : Not less than 99.0%



Storage conditions : In airtight containers, in dry place, protected from light.

Recommended storage: 10°C~30°C



Specs:

TEST ITEM SPECIFICATIONS
Appearance Yellowish or light orange-yellow, crystalline powder
Melting rage Between 221ºC - 226ºC
Identification (1) HPLC: The retention time of the major peak of the sample solution corresponds to that of the standard solutions, as obtained in the assay
(2)IR: The spectrum of sample conforms to that of the reference spectrum.
Appearance of solution The solution is not more opalescent than reference suspension I and not more intensely coloured than reference solution Y4 or GY4.
Fluoroquinolonic acid Not more than 0.2%
Related substances

Any other single impurities
Total impurities
Not more than 0.4%
Not more than 0.3%
Not more than 0.7%
Loss on drying Not more than 0.5%
Heavy metals Not more than 20 ppm
Residue on ignition Not more than 0.2%
Assay (on the dried basis) Not less than 99.0%







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