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Rocuronium Bromide Intermediate
þðèäè÷åñêè?óñ
2b-(morpholin-4-yl)-16-b-(pyrrolidin-1-yl)-5¥á-androstan-3¥á,b17-diol
Rocuronium Bromide intermediate
Description White to off white powder MPAD -01
Identification:
a)IR spectrum
IR spectrum of the test sample complies with the IR spectrum of the Reference Standard MPAD - 02
Loss on drying Not more than 0.5% MPAD -03
Water (KF) Not more than 0.5% MPAD -04
Residue on ignition Not more than 0.1% MPAD -05
Specific optical rotation (calculated on dried basis) +85 o to +87o MPAD –
06
Related substances (HPLC)
EPAO
Iso-MPAD
DPAD
Impurity at RRt ~0.25
Impurity at RRt ~0.55
Impurity at RRt ~1.26
Any other unidentified
Total
Not more than 0.2%
Not more than 0.2%
Not more than 0.5%
Not more than 1.7%
Not more than 0.6%
Not more than 0.5%
Not more than 0.2%
Not more than 2.5% MPAD -07
Assay ( titration)
(calculated on dried basis) Not less than 98.0% MPAD-09
Morpholine Less than 0.2% MPAD -07


Ed. no. 3
Supersedes Ed. no. 2 from February 7, 2006

Issued by Analytical R&D Director: A. Klempfner Date:

Approved by R&D Director: Y. Gafni Date:

Approved by QC Manager: M. Unterman Date:

Approved by QA Manager: A. Kost Date:

Beijing Oriental Berger S&T Co.,Ltd
Industrial field others, pharmaceutical
Beijing OrientalBergerS&TCo.,Ltd
Phone 010-51800039
Fax 010-51803870
Homepage www.obst-bj.com
E-mail qli@obst-bj.com
Address Room1111 , Building 7 District 2,Jingtie¡¡¡¡ Homestead,Fengtai District BJ
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