Business Type:Trading Company
Product Certification&
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Country: China (Mainland)
Business Type:Trading Company
CAS NO.73590-58-6
A(1-2)Kilogram
Items |
Standard |
Results |
Appearance |
White or almost white powder |
Conforms |
Identification A.Thin-layer chromatography B. IR spectrophotometry |
Rf value of the principal spot observed in the chromatogram of test solution corresponds to that of the pricipal spot observed in the chromatogram of standard solution IR spectrum of omeprazole sample corresponds to that of omeprazole RS. |
Conforms Conforms |
Completeness of solution |
Clear |
Conforms |
Color of solution |
The absorbance at 440 nm is not greater than 0.10 |
0.01 |
Loss on drying |
≤0.5% |
0.03% |
Residue on ignition |
≤0.1% |
0.09% |
Heavy metals |
0.002% |
<0.002% |
Residual solvents Methylene chloride Methanol Acetone |
≤600ppm ≤3000ppm ≤5000ppm |
76ppm 164ppm 130ppm |
Chromatographic purity Any individual impurity Total impurities |
≤0.3% ≤1.0% |
0.04% 0.11% |
Microbial limits Bacteria Total molds and yeasts Controlled bacteria |
≤500 CFU/g ≤50 CFU/g Absence |
<10 CFU/g <10 CFU/g Undetectable |
Assay |
98.0%-102.0% |
100.9% |
Partical size |
≥85%(≤15um) |
96.1% |
Conclusion |
Conforming to USP 36 and in-house requirements. . |