Product Quality and Compliance, FHI 360, 2810 Meridian Parkway, Suite 160, Durham, NC 27713, USA.
Product Development and Introduction, FHI 360, 359 Blackwell Street, Suite 200, Durham, NC 27701, USA.
J Pharm Biomed Anal. 2020 Aug 5;187:113352. doi: 10.1016/j.jpba.2020.113352. Epub 2020 May 5.
Medroxyprogesterone acetate (MPA) injectable products are a key commodity for reproductive health and are available in the global market from a variety of manufacturing sources. Depending on the climatic zone conditions of the destination country for product use, MPA injectables are at risk of exposure to adverse transport and storage conditions. Analytical methods are available that quantify impurity levels in MPA and MPA injectable products, but minimal information is publicly available on the source of impurity and degradation product generation or the safety risk of these compounds. Forced degradation studies were conducted on MPA and MPA injectables to gain a better understanding of potential sources of impurities and degradation products. Furthermore, QSAR analysis was conducted to assess the toxicity risk of known impurities. More impurities were generated under acidic, basic, light, and oxidative forced degradation conditions relative to thermal degradation, however thermal exposure is the most likely adverse condition to be experienced by these products. Even if impurities are present in MPA injectables, QSAR analysis found that known impurities for MPA are apparently no more of a safety risk than MPA.
醋酸甲羟孕酮（MPA）注射剂是生殖健康的重要商品，在全球市场上有多种制造来源。根据产品使用目的地国家的气候带条件，MPA 注射剂有暴露于不利的运输和储存条件的风险。目前已有可定量测定 MPA 和 MPA 注射剂中杂质水平的分析方法，但关于杂质和降解产物生成的来源或这些化合物的安全风险的信息很少公开。对 MPA 和 MPA 注射剂进行了强制降解研究，以更好地了解杂质和降解产物的潜在来源。此外，还进行了定量构效关系（QSAR）分析以评估已知杂质的毒性风险。与热降解相比，在酸性、碱性、光照和氧化强制降解条件下生成了更多的杂质，但热暴露是这些产品最有可能经历的不利条件。即使 MPA 注射剂中存在杂质，QSAR 分析也发现 MPA 的已知杂质显然没有比 MPA 更大的安全风险。
