GMP Standard Active Pharmaceutical Ingredient Cephalexin Monohydrate

Model NO.: Compacted, Powder


Classification: API


Appearance: Powder


API: API


Transport Package: 25kgs/20kgs Drum


Origin: China




Efficacy: API


Type: API


Color: White


Trademark: SINOCHEM QINGDAO


Specification: USP


HS Code: 29419052




BASIC INFORMATION:



CAS NO.: 15686-71-2

Molecular Formula: C16H17N3O4S

Molecular Weight: 347.39

Standard: USP36

Test Items	Specification
Appearance	White to off-white, crystalline powder
Solubility	Slightly soluble in water; practically insoluble in alcohol, in chloroform, in ether.
Identification	IR spectrum of sample must be complies with that of reference standard. The retention time of the major peak of the sample solution corresponds to that of the Standard solution, asobtained in the Assay
Crystallinity	Complies
pH	3.0~5.5
Water	4.0%~8.0%
Optical Rotation (anhydrous substance )	+149°~+158°
Assay (anhydrous substance)	950µg/mg ~1030µg/mg
Related Substances
Individual Impurities	≤1.0%
Total Impurities	≤5.0%
Dimethylaniline	Not more than 20 ppm

APPLICATION:

API




PACKING:

25kg/20kg net weight in drum.





SHELF LIFE:

3 years





STORAGE:

Kept in tightly closed containers, it should be stored in a dry and ventilative warehouse, kept away from moisture and heat. Furthermore, it should be stored separately from poisonous substances.

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Product Categories : Active Pharmaceutical Ingredients