Rathinam K, Fernandez A C, Vedanarayanan P V, Bhujle V V, Srinivasan K
Toxicol Lett. 1983 Mar;15(4):329-34. doi: 10.1016/0378-4274(83)90152-2.
Conclusive evidence for the presence of di(2-ethylhexyl) phthalate (DEHP) in 15 out of 17 commercially available sodium chloride injection (Indian Pharmacopoeia) samples was obtained and concentration levels as high as 11.0 mg/500 ml of saline were detected. The presence of such contaminants in i.v. fluids, avoidable by the institution of appropriate quality control measures before manufacturing and marketing, is a matter of serious concern. Stipulated specifications in different pharmacopoeias are meant only to ensure sterility and pyrogenicity, and it is advisable that cognisance be taken of the presence of toxic contaminants e.g. di(2-ethylhexyl) phthalate.
在17个市售氯化钠注射液（印度药典）样品中，有15个检测到确凿证据表明含有邻苯二甲酸二（2-乙基己基）酯（DEHP），检测到的浓度高达11.0毫克/500毫升生理盐水。静脉输液中存在此类污染物，在生产和销售前通过实施适当的质量控制措施本可避免，这是一个严重令人担忧的问题。不同药典规定的标准仅旨在确保无菌性和无热原性，建议关注有毒污染物如邻苯二甲酸二（2-乙基己基）酯的存在。
