Abstract
The antihypertensive drug substance amlodipine besylate crystallizes in two stable crystal forms, an anhydrate and a hitherto unknown monohydrate. Both forms have been characterized by thermal analysis, X-ray powder diffractometry, FTIR- and FT Raman spectroscopy. Moisture sorption- and desorption investigations reveal their unusual physical stability in a broad range of relative humidities. The monohydrate forms an isomorphic dehydrate upon dehydration, which was elucidated by variable temperature X-ray powder diffractometry. Physico-chemical properties as well as relative stabilities of the crystal forms are described and discussed based on a comprehensive analytical identification, and enable an estimation of practical relevance for manufacturing of amlodipine besylate solid dosage forms.
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