کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
5551056 1402937 2017 8 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Identification of an exposure risk to heavy metals from pharmaceutical-grade rubber stoppers
ترجمه فارسی عنوان
شناسایی خطر قرار گرفتن در معرض فلزات سنگین از سوپاپ های لاستیکی درجه دارویی
موضوعات مرتبط
علوم زیستی و بیوفناوری علوم کشاورزی و بیولوژیک دانش تغذیه
چکیده انگلیسی

Exposure to low concentrations of heavy metals and metalloids represents a well-documented risk to animal and human health. However, current standards (European Pharmacopeia [EP], United States Pharmacopoeia [USP], International Organization for Standardization [ISO], YBB concerned with rubber closures) only require testing for Zn in pharmaceutical-grade rubber stoppers and then using only pure water as a solvent. We extracted and quantified heavy metals and trace elements from pharmaceutical-grade rubber stoppers under conditions that might occur during the preparation of drugs. Pure water, saline, 10% glucose, 3% acetic acid (w/v), 0.1 mol/L hydrochloric acid, and diethylenetriaminepentaacetic acid (4 mg/mL, 0.4 mg/mL, and 0.04 mg/mL) were used as extraction agents. We quantified the extracted arsenic, lead, antimony, iron, magnesium, aluminum, and zinc using inductively coupled plasma mass spectrometry. The concentration of extracted metals varied depending on the different extraction solutions used and between the different rubber stopper manufacturers. Rubber stoppers are ubiquitously used in the pharmaceutical industry for the storage and preparation of drugs. Extraction of heavy metals during the manufacturing and preparation of drugs represents a significant risk, suggesting a need for industry standards to focus on heavy metal migration from rubber stoppers.

161

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Food and Drug Analysis - Volume 25, Issue 3, July 2017, Pages 723-730
نویسندگان
, ,