- Fresh Citrus Fruit[6]
- Veterinary Medicine[6]
- Silk Fiber[4]
- 100% Silk Yarn[2]
- Carbonate[3]
- Contact Person : Ms. Liu Afra
- Company Name : Sichuan Lanyan Import & Export Co., Ltd.
- Tel : 0086-0833-2412124
- Fax : 0086-0833-2115333
- Address : Sichuan,Leshan,Huifengyuan, 32# Baiyang Road
- Country/Region : China
- Zip : 614000
API raw material oxytetracycline dihydrate injectable
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| TEST | EP7.0 | |
| ITEM | SPECIFICATION | RESULT |
Streptomycin sulphate Formula | ||
| Characters | Appearance:yellow,crystalline powder. Solubility:very slightly soluble in water.It dissolves in dilute acid and alkaline solutions. | Appearance: pale,yellow crystalline powder Solubility:complies |
| Identification | A.Thin-layer chromatogram meets the requirements B. Positive C.Positive | Complies Positive Positive
|
pH | 4.5-7.5 | 4.9 |
| Specific optical rotation | -203°— -216° | -212° |
| absorbance(353nm) | 290 — 310 | 301 |
Light-absorbing impurities | 430nm:NMT0.25 490nm:NMT0.20 | 0.11 0.02 |
| Related substances | Impurity A:4-epioxytetracycline NMT 0.5% Impurity B:Tetracycline NMT 2.0% Impurity C: Other substances NMT 2.0% | 0.17% 0.61% 1.10% |
| Heavy metals | NMT 50ppm | less than 50ppm |
| Water | 6.0—9.0% | 7.8% |
| Sterility | Meets the requirement | Complies |
| sulphate ash | NMT 0.5% | 0.1% |
| Assay(HPLC) | 95.0%-102.0%(anhydrous) | 100.3%(anhydrous) 92.5%(as is) |
| Conclusion | Complies with EP7.0 | |
| Remark | Bacterial endotoxins less than 0.4 IU/mg(internal) |
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API raw material oxytetracycline dihydrate injectable
