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

By Richard J. Smith, Michael L. Webb

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The degree of crystal damage could be directly correlated with the energy of the milling process. Using flow microcalorimetry (ITC), the authors showed that this could also be correlated by increases in enthalpy of water vapour adsorption, consistent with increases in amorphicity. 7 Hydrolysis One of the most common pathways of drug product degradation is hydrolysis. Flutamide, a non-steriodal anti-androgen, is an acetanilide derivative and undergoes both acid- and base-catalysed amide hydrolysis [51], at the extremes of pH to form 4-nitro-3-trifluoromethylaniline (NTMA).

The understanding of some photodegradation pathways appears to be still in its infancy. Photostability studies on a new ester of methylprednisolone ORGANIC IMPURITIES IN DRUG PRODUCTS 35 identified two unknown degradation products, in addition to the well-established oxidation (17-keto and 11-keto) and hydrolytic (methylprednisolone) pathways [77]. 0] hex-3-en-2-one intermediate and subsequent rearrangement of the cross-conjugated dienones. Surprisingly, one of the new degradation products (1, 11-epoxy) was formed in high yields.

5 h grinding in a ‘mixer’ mill. The formation of the pyridine photodegradation product was monitored on the surface of tablets using FT-IR. The authors indicated that as solid-state photodegradation is a surface phenomenon, FT-IR was more appropriate than HPLC. 046 per day). 5 times). 061 per day). These findings were in accord with those of Qin and Frech [89], who reported that the photodegradation rate of the amorphous form of the development drug, MK-912, was approximately 40 times greater than its crystalline counterpart, under ICH irradiation conditions.

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