CAS number： 64-75-5;1170-81-6
Molecular formula： C22H25ClN2O8
molecular weight： 480.8955
Chemical structure：
| Product name: | Tetracycline hydrochloride | ||
| Expiry Date: | Four years | ||
| Inspection Standard: | BP | ||
| Tests | BP Specification | EP Specification | Results |
| Characters | Yellow crystalline powder | Yellow crystalline powder | Yellow crystalline powder |
| Soluble in water, slightly soluble in ethanol(96 percent), practically insoluble in acetone | Soluble in water, slightly soluble in ethanol(96 percent). Practically insoluble in acetone | Positive reaction | |
Identification: A. TLC B. Color Reaction C. Chlorides | Conform to the reference | Positive reaction(pass) | |
| To about 2mg add 5ml of sulphuric add the solutio to 2.5ml of water. The color becomes yellow. | Positive reaction(pass) | ||
| Reaction of chlorides | Positive reaction(pass) | ||
| Acidity(pH): | 1.8～2.8 | 1.8～2.8 | 2.39 |
| Specific optical rotation( dried substance): | -240°～-255° | -240°～-255° | -246 |
| Loss on drying | ≤2.0% | ≤2.0% | 0.13% |
| Heavy metals | ≤50 ppm | ≤50 ppm | ＜40 ppm |
| Sulphated ash | ≤0.5% | ≤0.5% | 0.03% |
| Related substances: | |||
| 4-Epitetracycline | ≤3.0% | ≤3.0% | 1.53% |
| 4-Epianhydrotetracycline | ≤0.5% | ≤0.5% | ND |
| Anhydrotetracycline | ≤0.5% | ≤0.5% | 0.15% |
| 2-Acetyl-2-decarbamoyltetracycline | ≤1.5% | ≤1.5% | 0.53% |
| Assay | 95.0%～102.0% | 95.0%～102.0% | 97.5% |
| Residual solvent | Acetone (G.C) ≤100 ppm | ＜0.62 ppm | |
| n-Butanol(G.C) ≤3000 ppm | 2734 ppm | ||
| Microbiological examination | TAMC ≤1000 cfu/g | Corresponds | |
| TYMC ≤100 cfu/g | Corresponds | ||
| E.coli Absence | Corresponds | ||
| Conclusion : The product conforms to standard of EP/BP | |||
