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Terazosin hydrochloride dihydrate is used to treat hypertension and prostatic hypertrophy.
| tem | Standard | |
| Identification | A.H-NMR:Comply with the structure | |
| B.LC-MS:Comply with the structure | ||
| C.The IR spectrum of sample should be identical with that of reference standard; | ||
| D.HPLC-ESI-MS The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in the Assay. | ||
| Crystallinity | meets the requirements. | |
| Loss on drying | ≤2.0% | |
| Heavy metals | ≤10 ppm | |
| Water | ≤1.0% | |
| Sulphated ash | ≤0.5%, determined on 1.0 g. | |
| Related substances | Unspecified impurities: for each impurity | ≤0.10% |
| Total Impurity | ≤0.5% | |
| Purity | ≥99.0% | |
| Assay | 99.0%~101.0% (anhydrous substance). | |
| Microbiological Analysis | ||
| Total plate count | ≤1000cfu/g | |
| Yeast and Moulds | ≤100cfu/g | |
| E. Coli. | Absent | |
| Salmonella | Absent | |
| S.aureus | Absent | |
| Product parameters | |
| Cas number: | 70024-40-7 |
| Appearance: | White crystalline powder |
| Purity: | 99%min |
| Package details: | 1kg/foil bag;25kg/drum |
| Brand: | Fortunachem |
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