结合雌激素原料药的重金属检查

Limit test of heavy metal in conjunctive estrones drug substance

目的:对结合雌激素原料药中的重金属进行限量检查。方法:以《中国药典》磷酸氢钙的重金属检查法第一法代替(中国药典)附录重金属检查Ⅱ法测定。结果:三批用《中国药典》附录重金属检查Ⅱ法无法测定的结合雌激素原料药以该方法测定.专属性较好,重金属含量均小于20 ppm。结论:该方法能用于结合雌激素原料药中重金属的限量检查,测定结果可靠。

Objective: To develop a method for the limit test of heavy metal in conjunctive estrones drug substance. Methods: The heavy metal in conjunctive estrones was determined by the ChP method I of heavy metal limit test in calcium hydrogen phosphate. Results: Three batches of cnjunctive etrones drug substance were determined by the new established method and showed good specification, which ChP methods of heavy metal limit test in Appendix VIII H can not determine. Conclusion: This method is reliable and applicable to the limit test of heavy metal in conjunctive estrones drug substance.