[PDF.05lr] Handbook of Isolation and Characterization of Impurities in Pharmaceuticals, Volume 5 (Separation Science and Technology)

Handbook of Isolation and Characterization of Impurities in Pharmaceuticals, Volume 5 (Separation Science and Technology)

[PDF.oo87] Handbook of Isolation and Characterization of Impurities in Pharmaceuticals, Volume 5 (Separation Science and Technology)

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 | #5588290 in Books |  2003-08-01 | Original language:English | PDF # 1 |  10.00 x.99 x6.90l,2.28 | File type: PDF | 430 pages

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The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized.

Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an...

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