Complaint
Product Name | Tetracycline hydrochloride |
Appearance | White powder |
Assay | 10%,20%,40% water soluble,98% fat-soluble Tetracycline hydrochloride |
CAS No. | 64-75-5 |
Molecular Formula | C22H25ClN2O8 |
Molecular Weight | 480.896 |
Melting point | 220-223 °C(lit.) |
Grade | Medicine Grade |
Test Method | HPLC |
Storage | Store in cool and dry place,keep away from strong light. |
Shelf life | 2 years when properly stored. |
| Item of Analysis | Specification | Results | Test Methods |
| Assay(on the anhydrous basis ) | 98%~101% | 99.20% | HPLC |
| Appearance | White powder | Conform | Visual |
| Identification | |||
| A: IR | Corresponds qualitatively to the reference | Complies | USP41-NF36 |
| B: Color Reaction | A blue color appears | Positive | USP41-NF36 |
| Water(KF) | ≤0.2% | 0.03% | USP41-NF36 |
| Residue on ignition | ≤0.1% | 0.02% | USP41-NF36 |
| Mesh size | Not less than 90% pass 80 mesh | Complies | 80 mesh screen |
| Residual Solvents | Ethanol ≤1000ppm | 18ppm | USP41-NF36 |
| Heavy metals | Inorganic arsenic ≤3μg/g | 0.06μg/g | USP41-NF36 |
| Total Hg ≤3μg/g | <0.01μg/g | USP41-NF36 | |
| Lead ≤1μg/g | 0.09μg/g | USP41-NF36 | |
| Chromatographic purity | Test 1: Coenzyme Q7,Q8,Q9,Q11 and related impurities:≤1.0% Test 2: 2Z isomer and related impurities:≤1.0% Test 1 & Test 2: ≤1.5% Test 3: The single related impurities≤0.3% | 0.37% 0.05% 0.42% 0.25% | USP41-NF36 |
| Total Plate Count | ≤1000cfu/g | <10 cfu/g | USP41-NF36 |
| Yeast & Mold | ≤100cfu/g | <15 cfu/g | USP41-NF36 |
| E. Coli. | Negative | Negative | USP41-NF36 |
| Salmonelle | Negative | Negative | USP41-NF36 |
| S.aureus | Negative | Negative | USP41-NF36 |
