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 |