Business Type:Trading Company
Product Certification&
Enterprise Certification
Country: China (Mainland)
Business Type:Trading Company
CAS NO.130693-82-2
A(1-2)Kilogram
Items | Specification | Results |
Description | White or almost white crystalline powder | Complies |
Identification | a) IR spectrum | Complies |
b) By HPLC | ||
c) Chlorides | ||
Water | Not more than 0.5% (Using 0.4g) | 0.18% |
Residue on ignition | Not more than 0.1% | 0.01% |
Heavy metals | Not more than 0.001% | Complies |
Limit of Dorzolamide | Not more than 0.5% | 0.10% |
Hydrochloride related compound "A" | ||
Chromatographic purity | ||
Individual impurity: | Not more than 0.1% | 0.10% |
Total imurities: | Not more than 0.5% | 0.20% |
Organic volatile | ||
impurities | ||
Acetone : | Not more than 5000ppm | Complies |
Acetonitrile : | Not more than 410ppm | Complies |
Ethyl acetate : | Not more than 5000ppm | Complies |
Hexane : | Not more than 290ppm | Complies |
Methanol : | Not more than 3000ppm | Complies |
Tetrahydrofuran : | Not more than 720ppm | Complies |
Toluene : | Not more than 890ppm | Complies |
Isopropyl alcohol: | Not more than 5000ppm | Complies |
Chloroform: | Not more than 60ppm | Complies |
1,4 - dioxane: | Not more than 380ppm | Complies |
Trichloroethene: | Not more than 80ppm | Complies |
Dichloromethane: | Not more than 600ppm | Complies |
Assay (On anhydrous basis) | 99.0% ~ 101.0% (C10H16N2O4S3.HCl) | 99.40% |
Conclusion | The results conform to USP31 |
Hypertansion