By Myra L. Weiner, Lois A. Kotkoskie
This ebook reports the heritage, regulatory prestige, pharmacopeial necessities, and harmonization of pharmaceutical excipients within the usa and Europe, and gives a finished knowing of the present medical foundation for defense review and hazard overview. Examines excipients as a special category of goods and explores new strategies for choosing toxicity! A well timed and exact addition to the pharmaceutical literature, containing over 570 citations that help and improve the textual content, Excipient Toxicity and security ·identifies the variations among excipients (inactive ingredients), meals parts, and drug items ·evaluates problems with dose management, species choice, and learn layout for numerous routes of publicity ·provides targeted details at the historic makes use of of excipients in drug formulations ·clarifies the protection Committee of the foreign Pharmaceutical Excipients Council's (IPEC) guidance and technical requisites for engaging in exams for every direction of publicity ·explains how info generated in toxicity versions are utilized to spot dangers in drug formulations ·details publicity review to hyperlink probability id with hazard ·considers the necessities and value of purity requirements ·and even more! Excipient Toxicity and protection is a blue-ribbon reference perfect for pharmacists; toxicologists; pharmacologists; analytical chemists; qc, caliber insurance, and regulatory compliance managers; and upper-level undergraduate and graduate scholars in those disciplines.
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Additional info for Excipient Toxicity and Safety (Drugs and the Pharmaceutical Sciences)
2% (determined by a titrimetric method) and, in the framework of international harmonization, has been changed for toxicological reasons to maximum 10 ppm, determined by high-performance liquid chromatography (HPLC). Besides residual monomer, povidones can also contain hydrazine as a side product from the chemical reaction; its formation and concentration depend on the process conditions. Pharmacopeias limit this toxic impurity at maximum 1 ppm. Cross-linked variants (crospovidone) and variants manufactured by copolymerization with vinyl acetate (copolyvidone) are also widely used as excipients.
140 ppm Ϫ Not detectable Ϫ Max. 1% Ϫ Ϫ Max. 500 Ϫ Max. 5% Ϫ Ϫ Ϫ Max. 2% Ϫ Ϫ Ϫ Ϫ Ϫ Ϫ Ϫ Ϫ Ϫ Ϫ Ϫ Ϫ Max. 0% Max. 2% Max. 1% Max. 1% Neutral Neutral Not detectable Not detectable Max. 3 ppm Ϫ Ϫ Ϫ Ϫ Ϫ Max. 40 ppm Max. 10 ppm Max. 4 ppm Ϫ Ϫ Purity of Excipients 29 1. Ethanol Because of a state monopoly for alcohol in many countries, harmonization of pharmacopeial monographs for ethanol has not been realized yet at the European Union (EU) level. A comparison, including the British Pharmacopoeia (BP), the German Pharmacopoeia (DAB), the French Pharmacopoeia (FP), the Swiss Pharmacopoeia (Ph.
Acetaldehyde or diacetal); and the differentiation between pure and denatured grades. A highly effective GC method, together with testing of the substance by ultraviolet (UV) and infrared (IR) spectroscopy are the core elements for such a monograph. 0 µm) provided the best selectivity. This GC system was applied to 28 samples of pure ethanol from different sources all over the world, stemming from different source materials and production processes. 4 Wine Brandy Isopropyl tert-Butyl n-Propyl sec-Butyl iso-Butyl tert-Amyl n-Butyl iso-Amyl n-Amyl 3-Hexyl 1-Hexyl Acetaldehyde Methanol Acetone alcohol alcohol alcohol alcohol alcohol alcohol alcohol Acetaldehydetdiacetal alcohol alcohol alcohol Furfurol alcohol Unknown Ethanol No.