Active Pharmaceutical Ingredients

White crystalline powder, hygroscopic, soluble in water. Used as a contraceptive (uterotonic) Appearance White or almost white powder Dissolubility Very soluble in water. It dissolves in diluteSolutions of acetic acid and of ethanol (96%) HPLC Retention time conforms to that of reference Ph 3.0-6.0 Water (KF) ≤5.0% Related substances(by HPLC) Individual ≤1.5%Together ≤5.0% Amino acids Asp 0.90~1.10Glu 0.90~1.10Pro 0.90~1.10Gly 0.90~1.10Leu 0.90~1.10Ile 0.90~1.10Tyr 0.70~1.05Half-Cys 1.40~2.10 Acetic acid (by HPLC) 6%-10% Bacterial endotoxin <300 IU/mg Total bacterial count ≤100 CFU/g Assay (by HPLC) 93.0%~102.0% Activity Potency≥480 IU/mg Conclusion It conforms to EP 8.0 and USP 37. Storage Protection to light, at a temperature of 2 °C to 8 °C. Package: 10G/bag; 1KG/bag . Storage: Protection to light, at a temperature of 2 °C to 8 °C. Avoid to moisture.,Disclaimer: The above content is for reference and communication only among industry insiders, and does not guarantee its accuracy or completeness. According to relevant laws and regulations and the regulations of this website, units or individuals who purchase related items should obtain valid qualifications and qualification conditions.