Analysis of Drug Impurities (Sheffield Analytical Chemistry by Richard J. Smith, Michael L. Webb

By Richard J. Smith, Michael L. Webb

Show description

Read Online or Download Analysis of Drug Impurities (Sheffield Analytical Chemistry Series) PDF

Best chemistry books

Biochemical Targets of Plant Bioactive Compounds: A Pharmacological Reference Guide to Sites of Action and Biological Effects

This completely listed publication summarizes a wealth of data at the biochemical pursuits of plant shielding compounds, and is an a useful reference for all biomedical pros.

Hydrogeochemische Stoffflussmodelle: Leitfaden zur Modellierung der Beschaffenheitsentwicklung von Grund- und Rohwassern (German Edition)

Leichter Einstieg: Bei Grundwasservorkommen, die zur Trinkwasserversorgung genutzt werden, gewinnen Aspekte der Wasserbeschaffenheit zunehmend an Bedeutung. Wer geochemische Prozesse versteht, kann diese bewerten und managen. Der lehrbuchartige Aufbau stellt Grundlagen und Hintergrundinformationen in shape kurzer Exkurse vor.

The Biological Chemistry of Iron: A Look at the Metabolism of Iron and Its Subsequent Uses in Living Organisms Proceedings of the NATO Advanced Study Institute held at Edmonton, Alberta, Canada, August 13 – September 4, 1981

The result of a NATO complex research Institute (ASI) entitled "Coordination Chemistry Environments in Iron-Containing Proteins and Enzymes - together with Smaller Molecules and version structures" are summarized during this publication. The ASI used to be held within the Province of Alberta, Canada, from August 23 to September four, 1981.

Extra info for Analysis of Drug Impurities (Sheffield Analytical Chemistry Series)

Example text

Webb Copyright © 2007 Blackwell Publishing 2 Organic impurities in drug products: origin, control and measurement David P. 1 Introduction Drug products contain both drug substance (sometimes referred to as the Active Pharmaceutical Ingredient [API]) and excipients. The resultant biological, chemical and physical properties of the drug product are directly dependent on the excipients chosen, their concentration and interactions with the API [1]. Excipients are sub-divided into various functional classifications, depending on the role that they are intended to play in the resultant formulation, for example, fillers, disintegrants, binders, lubricants and glidants.

Excipients, and the impurities present therein, can stabilise and/or destabilise drug products. The allowable level of any given impurity or impurities that are permitted in drug products, without explicit non-clinical safety testing, are defined by ICH Q3B (R) [4]. Synthetic impurities per se are covered by separate guidelines, ICH Q3A (R) [5]. The amounts of impurities that are allowable are based on the total daily intake of the drug product. There are separate limits (or thresholds) for reporting, identification and qualification of drug product impurities, sometimes referred to as degradants or degradation products.

The authors showed clear superiority of the opacified topical formulation containing 4% titanium dioxide versus the standard clear gel. An elegant publication from Aman and Thoma [84] outlined the various options open to the stabilisation of photolabile oral products. The addition of lightabsorbing agents is a well-established approach to stabilising photolabile products [85]. 3 Source: Derived from [86]. molsidomine tablets. Pigments were superior to colorants or UV absorbers. However, they warned that the use of titanium dioxide (an opacifier) needs to be considered carefully.

Download PDF sample

Rated 4.69 of 5 – based on 13 votes