Supporting Information for Identification, synthesis and characterization of process related impurities of benidipine hydrochloride, stress-testing / stability studies and HPLC/UPLC method validations
Esen Bellur Aticia,*, Bekir Karlığaa
a
Deva Holding A.Ş., Çerkezköy-2 Production Plant, Karaağaç Mh. Fatih Blv. No: 26 Adres
No: 2278035833 Kapaklı – Tekirdağ / TURKEY *Corresponding author. Tel: +90 282 7581771 (4413), Fax: +90 282 7581770 E-mail addresses:
[email protected],
[email protected]
Table of contents 1
H, 13C and DEPT NMR; IR, Mass spectral data and DSC thermogram of:
Benidipine HCl
2
Ben-1
8
Ben-1 acid
14
Ben-bis impurity
20
Ben-ox impurity
25
β-Isomer impurity
32
Ben-desbenzyl impurity
38
HPLC chromatograms: Benidipine spiked with impurities and individual HPLC chromatograms 1
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