The occurrence of phthalic acid esters in various samples of commercially available sodium chloride injections (Indian Pharmacopoeia).
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.
D004051:Diethylhexyl Phthalate / Q000032:analysis*; D004340:Drug Contamination; D004349:Drug Packaging; D005898:Glass; D007194:India; D010602:Pharmacopoeias as Topic; D010795:Phthalic Acids / Q000032:analysis*; D011143:Polyvinyl Chloride; D011786:Quality Control; D012965:Sodium Chloride / Q000032:analysis*; D012996:Solutions / Q000032:analysis; D013055:Spectrophotometry, Infrared; D013056:Spectrophotometry, Ultraviolet
D010795:Phthalic Acids; D012996:Solutions; D012965:Sodium Chloride; D011143:Polyvinyl Chloride; D004051:Diethylhexyl Phthalate