Polymorphism of rac-5,6-diisobutyryloxy-2-methylamino-1,2,3,4-tetrahydro-naphthalene hydrochloride (CHF 1035). I. Thermal, spectroscopic, and X-ray diffraction properties.

Abstract:

:The polymorphism of rac-5,6-diisobutyryloxy-2-methylamino-1,2,3,4-tetrahydro-naphthalene hydrochloride (CHF 1035) was investigated. Three different crystal forms (Form I, Form II, and Form III) were obtained by recrystallization procedures from common organic solvents. The polymorphs were characterized by Raman and carbon-13 nuclear magnetic resonance ((13)C NMR) spectroscopy, in solution and in solid state (cross polarization-magic angle spinning), powder X-ray diffractometry, and thermal methods (differential scanning calorimetry, hot stage microscopy, and thermogravimetry). Moreover, the diffraction patterns of Form I, collected at controlled temperatures, gave evidence of the presence of two reversible structural rearrangements at approximately 60 and approximately 75 degrees C. These structural variations were confirmed by the results obtained by differential scanning calorimetry and hot stage microscopy techniques. The analysis of the Raman spectra allowed the identification of peculiar absorption bands for each polymorph. Form III was the stable crystal form at room temperature as determined by the basis of slurry conversion method.

journal_name

J Pharm Sci

authors

Giordano F,Rossi A,Moyano JR,Gazzaniga A,Massarotti V,Bini M,Capsoni D,Peveri T,Redenti E,Carima L,Dagli Alberi M,Zanol M

doi

10.1002/jps.1069

subject

Has Abstract

pub_date

2001-08-01 00:00:00

pages

1154-63

issue

8

eissn

0022-3549

issn

1520-6017

pii

S0022-3549(16)30791-2

journal_volume

90

pub_type

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