By Myra L. Weiner, Lois A. Kotkoskie
Examines excipients as a distinct category of goods and explores new methods for settling on toxicity! A well timed and targeted 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), meals constituents, and drug items evaluates problems with dose management, species choice, and research layout for varied routes of publicity, offers distinctive details at the ancient makes use of of excipients in drug formulations, clarifies the security Committee of the overseas Pharmaceutical Excipients Councils (IPEC) instructions and technical standards for carrying out checks for every path of publicity, explains how facts generated in toxicity types are utilized to spot dangers in drug formulations, information publicity evaluation to hyperlink possibility id with possibility considers the necessities and significance of purity necessities and masses extra! 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 resources for Excipient Toxicity and Safety
Acetaldehyde (GC): max 10 ppm (v/v) 5. Acetaldehyde diethyl acetal (GC): max 30 ppm (v/v) 6. Acetaldehyde—equivalents (sum 4 ϩ 5) (GC) :max 10 ppm 7. Benzene (BP UV-method) : max 2 ppm (v/v) 8. UV-absorbing compounds 235–340 nm, 5 cm cell (modified USP method) : Absorption 240 nm: max. 40; 250 nm: max. 30; 260 nm: max. 30; 270– 340 nm: max. 10 9. 0025% (m/v) Ja¨kel and Keck 36 IV. SPECIFIC IMPURITIES A. Inorganic Impurities 1. Heavy Metals If we consider the frequency of the heavy metal test (8) in pharmacopeial monographs, it is the most important test for inorganic impurities in excipients and active ingredients, together with the test for sulfated ash.
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. ), the JP, and the USP is compiled in Table 4.
02 Max. 01 N HCl/15 mL a Bromocresyl green Ϫ Max. 3 (kg m Ϫ3) Max. 2 ppm Ͻ Color standard Ϫ Max. d. Max. 5 ppm a Ϫ Ϫ Ϫ ϭ Max. 100 ppm acetaldehyde Max. 02% methanol Max. 03 area% Other impurities 1 cm 240 nm max. 10 250–260 nm max. 06 270 nm max. 03 Ϫ Ϫ Ϫ Ϫ Clear Colorless Max. 25 ppm Max. 25 ppm Ϫ Clear Purity of Excipients 27 Ja¨kel and Keck 28 to the question: What is a reliable quality standardization from the scientific and technical point of view? Simultaneously, they highlight the problems associated with legally binding standards in different world regions and emphasize the necessity and importance of the International Harmonization of Excipient Quality Standards initiated by the EP, JP, and USP Commission (for more details, see Chapter 14).