1.own factory (GMP) in this line over 30years. 2.good quality obtained EP 3.enjoy good reputation in a competitive price CertificationOur products have DMF certification through the European UnionPackaging & DeliveryPackaging Detail 15KG per Drum( 60cm*40cmDelivery Detail ASAP upon order from China main portSpecifications
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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veterinary drugs/medicine food grade EP/USP/FDA/GMP Animal Pharmaceutical injectable oxytetracycline dihydrate