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| Product Name | Doxycycline HCL BP | ||||
| Quanlity Standard: | BP2007 | ||||
| ITEM | SPECIFICATION | ||||
| Characters: | Yellow crystalline powder | ||||
| Identification: | A.tR of HPLC test | ||||
| B.Sulphuric acid yellow color reaction | |||||
| C.Chloride's reaction | |||||
| PH: | 2.0 to 3.0 | ||||
| Specific Optical Rotation | .-105° to -120°,calculated on the anhydrous,ethanol-free substance. | ||||
| Specific Absorbance: | 300-335 at 349nm,calculated on the anhydrous,ethanol-free substance. | ||||
| Light-absorbing Impurities: | Not more than 0.07 at 490nm,calculated on the anhydrous,ethanol-free substance | ||||
| Related Substances | |||||
| Metacycline: | Not more than 2.0% | ||||
| 6-epidoxycycline: | Not more than 2.0% | ||||
| Any individual impurities: | Not more than 0.5% | ||||
| Disregard limit: | Not more than 0.1% | ||||
| Ethanol: | 4.3 to 6.0% | ||||
| Heavy Metals: | Less than 50ppm | ||||
| Water: | 1.4% to 2.8% | ||||
| Sulphated Ash: | Not more than 0.4% | ||||
| Assay: | 95.0-102.0% of C22H25CIN2O8 calculated on the anhydrous,ethanol-free substance. | ||||
DOXYCYCLINE HCL BP