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Econazole Nitrate EP8

Product Name: Econazole Nitrate EP8

CAS No.: 24169-02-6

CAS NO: 24169-02-6

Molecular Formula: C18H16Cl3N3O4

Properties: White or almost white crystalline powder

Usage: It is used for the treatment of cutaneous candidiasis, and also for the treatment of tinea corporis, tinea corporis, tinea cruris, tinea pedis, tinea versicolor, etc.

Package: 25KG/DRUM

Storage:  Keep containers closed and stored in cool and well ventilated places

Product Standard: USP

 

SPECIFICATION:

ITEMS

STANDARDS

Appearance

White or almost white crystalline powder

Identification

A. Infrared Absorption

B. The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the Assay

C. An intense blue color develops

Organic Impurities

Related compound A:NMT 0.375%

Related compound B:NMT 0.375%

Related compound C:NMT 0.375%

Econazole : absent

Any Individual unspecified impurity :

NMT 0.10%

Total impurity: NMT 2.0%

Loss on drying

Not more than 0.5%

Residue on ignition

Not more than 0.1%

Residual Solvent

Acetone: NMT 0.5%

Ethanol: NMT 0.5%

Assay

98.0%-102.0%(C18H15Cl13N2O.HNO3),

calculated on dried basis

Microorganism

TPC<1000cfu/g

Y and M <100cfu/g

E-coli - absent

Staphylococcus Aureus-Absent

Pseudomonas Aeruginosa-Absent

Albicans Saccharomyces-Absent

Remark:

Particle size: 90% pass 10 micron

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