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 |