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生产环境中激素类药物残留量检测验证

Verification on the Detection of Hormone Medicine Residues in the Factory Environments
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摘要 目的:论述生产环境中激素类药物残留量检测方法。方法:以醋酸氟轻松为例说明生产环境中激素类药物残留量的检测验证。结果:通过验证确认,环境中激素残留量低于验证标准。结论:生产环境中激素类药物醋酸氟轻松的残留量不会影响其他品种的产品质量和安全性。 Objective: To study the detecting method of hormone medicine residues in the factory environments. Methods: Taking Fluocinonide for example,to illustrate the verification on the detection of hormone medicines residues in the factory environments. Results: By confirming, the hormone medicine residues were lower than validation values. Conclusion: Hormone medicine residues in the factory environments had no effects on the product quality and security of other varieties.
出处 《黑龙江医药》 CAS 2009年第3期330-331,共2页 Heilongjiang Medicine journal
关键词 生产环境 激素类药物 残留量 检测验证 Factory environments Hormone medicines Residues Detecting verification
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  • 1Herbert J. Kaiser,Ph. D. & Bruce Ritts,M. S. Validation of Analytical Methods Used in Cleaning Validation [J]. Journal of Validation Technology, 2004,10 ( 3 ): 219.
  • 2Food and Drug Administration "Guide to Inspections,Validation of Cleaning Processes" Office of Regulatory Affairs,FDA,Rockville,MD,1993.
  • 3ICH "Guidance for Industry Q2B Validation of Analytical Procedures:Methodology"FDA, Rockville, MD 1996.

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