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The use of high-speed differential scanning calorimetry (Hyper-DSC) in the study of pharmaceutical polymorphs.

Abstract：

:The thermal properties of two polymorphs (A and C) of a Merck development compound were studied using high-speed differential scanning calorimetry (Hyper-DSC). The utility of this novel technique as a fast analytical tool for studying the polymorphic behaviour of metastable polymorphs has previously been demonstrated successfully for Carbamazepine. Accelerated heating rates can alter the kinetics of the melting transition of metastable polymorphs such that concurrent exothermic recrystallisation is inhibited. Here it is demonstrated that at heating rates of 400 degrees C/min concurrent recrystallisation of Polymorph A of the Merck development compound is inhibited allowing the enthalpy of fusion for the lower melting Polymorph C to be determined. The utility of the technique as a qualitative tool to detect the presence of polymorphic impurities was confirmed for levels much lower than 10% (w/w). However, seeding effects consistent with those reported previously for Carbamazepine were also observed for this structurally distinct molecule limiting the utility of the technique for accurate quantification of low levels of polymorphic impurities.

journal_name

Int J Pharm

journal_title

International journal of pharmaceutics

authors

McGregor C,Bines E

doi

10.1016/j.ijpharm.2007.08.015

subject

Has Abstract

pub_date

2008-02-28 00:00:00

pages

48-52

issue

1-2

eissn

0378-5173

issn

1873-3476

pii

S0378-5173(07)00698-9

journal_volume

350

pub_type

杂志文章

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