By Jann Hau; G L Van Hoosier
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Additional resources for Handbook of Laboratory Animal Science [Vol 2 - Animal Models]
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.