Title:
HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR POLYPEPTIDE MIXTURES
Document Type and Number:
WIPO Patent Application WO/2016/172855
Kind Code:
A1
Abstract:
Provided is a high performance liquid chromatography method for polypeptide mixtures. Specifically, the method comprises the following steps of (1) formulating a Glatiramer acetate solution to be tested; (2) subjecting the sample to be tested to gradient elution by way of anion exchange liquid chromatography, cation exchange liquid chromatography or reversed-phase liquid chromatography; and (3) detecting and analyzing peak areas corresponding to various components of the copolymer, and by means of comparison with a control, determining whether the content ranges of the various components in the sample to be tested are qualified.
Inventors:
TANG YANGMING (CN)
HE GANG (CN)
LI GUOTAO (CN)
TAO ANJIN (CN)
HE GANG (CN)
LI GUOTAO (CN)
TAO ANJIN (CN)
Application Number:
PCT/CN2015/077690
Publication Date:
November 03, 2016
Filing Date:
April 28, 2015
Export Citation:
Assignee:
HYBIO PHARMACEUTICAL CO LTD (CN)
TANG YANGMING (CN)
HE GANG (CN)
LI GUOTAO (CN)
TAO ANJIN (CN)
YUAN JIANCHENG (CN)
TANG YANGMING (CN)
HE GANG (CN)
LI GUOTAO (CN)
TAO ANJIN (CN)
YUAN JIANCHENG (CN)
International Classes:
C07K2/00; A61K31/785; A61K38/16; A61P25/28; C07K14/00
Domestic Patent References:
| WO2012123959A2 | 2012-09-20 |
Foreign References:
| US20090263347A1 | 2009-10-22 | |||
| CN103335873A | 2013-10-02 |
Other References:
See also references of EP 3290432A4
Attorney, Agent or Firm:
BEIJING CHENGHUI LAW FIRM (CN)
北京市诚辉律师事务所 (CN)
北京市诚辉律师事务所 (CN)
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