NDLI: Investigation of the solid state properties of amoxicillin trihydrate and the effect of powder pH

Content Provider	Springer Nature Link
Author	Ghassempour, Alireza Rafati, Hasan Adlnasab, Laleh Bashour, Yosef Ebrahimzadeh, Homeira Erfan, Mohammad
Copyright Year	2007
Abstract	The purpose of this research was to investigate some physicochemical and solid-state properties of amoxicillin trihydrate (AMT) with different powder pH within the pharmacopoeia-specified range. AMT batches prepared using Dane salt method with the pH values from 4.39 to 4.97 were subjected to further characterization studies. Optical and scanning electron microscopy showed that different batches of AMT powders were similar in crystal habit, but the length of the crystals increased as the pH increased. Further solid-state investigations using powder x-ray diffraction (PXRD) demonstrated the same PXRD pattern, but the intensity of the peaks raised by the powder pH, indicated increased crystallinity. Differential scanning calorimetry (DSC) studies further confirmed that as the powder pH increased, the crystallinity and, hence, thermal stability of AMT powders increased. Searching for the possible cause of the variations in the solid state properties, HPLC analysis showed that despite possessing the requirements of the United States Pharmacopoeia (USP) for purity/impurity profile, there was a direct relationship between the increase of the powder pH and the purity of AMT, and also decrease in the impurity I (α-Hydroxyphenylglycine) concentration in AMT powder. Recrystallization studies confirmed that the powder pH could be controlled by adjusting the pH of the crystallization.
Starting Page	91
Ending Page	96
Page Count	6
File Format	PDF
Journal	AAPS PharmSciTech
Volume Number	8
Issue Number	4
e-ISSN	15309932
Language	English
Publisher	Springer-Verlag
Publisher Date	2007-01-01
Publisher Institution	American Association of Pharmaceutical Scientists
Publisher Place	New York
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Amoxicillin trihydrate impurity profile degree of crystallinity DSC PXRD HPLC Pharmacology/Toxicology Biotechnology Biochemistry Pharmacy
Content Type	Text
Resource Type	Article

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