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By Myra L. Weiner, Lois A. Kotkoskie
Examines excipients as a different type of goods and explores new systems for selecting toxicity! A well timed and exact addition to the pharmaceutical literature, containing over 570 citations that aid and increase the textual content, Excipient Toxicity and protection identifies the variations among excipients (inactive ingredients), nutrition elements, and drug items evaluates problems with dose management, species choice, and learn layout for numerous routes of publicity, offers targeted details at the old makes use of of excipients in drug formulations, clarifies the security Committee of the overseas Pharmaceutical Excipients Councils (IPEC) directions and technical standards for engaging in exams for every course of publicity, explains how facts generated in toxicity versions are utilized to spot dangers in drug formulations, information publicity review to hyperlink risk id with hazard considers the necessities and value of purity requirements and lots more and plenty extra! Excipient Toxicity and safeguard is a blue-ribbon reference perfect for pharmacists toxicologists pharmacologists analytical chemists quality controls, caliber coverage, and regulatory compliance managers and upper-level undergraduate and graduate scholars in those disciplines.
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Proteins Among the potential impurities in excipients requiring special attention because of health reasons, the following two proteins need specific discussion: gluten and prion protein. 42 Ja¨kel and Keck a. Gluten. Gluten is the protein fraction from certain cereals that causes celiac disease, a severe degeneration of the intestinal mucosa associated with malabsorption of food. The frequency of this disease is, on average, approximately 1: 1500 individuals (12); however, the incidence can be considerably higher or lower in certain local regions (13,14).
5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 5 N HCl, 100°C, 30 min) Arsenic acid-soluble (H 2 SO 4 10%, 100°C ca. 1 min) Heavy metals, acid-soluble Lead acid-soluble Ph. II ϩ ϩ ϩ Ϫ Ϫ Max. 250 ppm Max. 4% USP XXII/ NF XVII JP XII Ϫ ϩ Ϫ ϩ Ϫ Ϫ ϩ Ϫ Ϫ ϩ Ϫ Ϫ Max. 6% Ϫ Max. 500 ppm Ϫ Not detectable Ϫ Max. 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.
The degradation pattern is usually oxidation following a free radical mechanism. Products of degradation are mole- 48 Ja¨kel and Keck cules with a high reactivity (mainly peroxides, aldehydes, and acids) that can easily interact with other substances in a formulation, including the active ingredient. The excess of excipients in a formulation can cause significant stability problems (as outlined in Sec. 1, of this chapter) even if the concentration of the degradation product of the excipient is low.