Title:
PROCAINE PENICILLIN AND PREPARATION METHOD THEREFOR, AND IMPURITY AND IMPURITY CONTROL METHOD
Document Type and Number:
WIPO Patent Application WO/2023/109157
Kind Code:
A1
Abstract:
Provided in the present invention are procaine penicillin and a preparation method therefor, and an impurity and an impurity control method, wherein the content of RRT0.24 impurity in the procaine penicillin is less than 0.13%. The preparation method is to control the content of the RRT0.24 impurity in the raw material used, namely procaine hydrochloride, to be not higher than 0.05%, wherein the RRT0.24 impurity is 2-{[2-(4-aminobenzoyloxy)ethyl](ethyl)amino}ethyl-4-aminobenzoate. The content y of the RRT0.24 impurity in the product procaine penicillin and the content x of the RRT0.24 impurity in the raw material, namely procaine hydrochloride, satisfy the linear relationship model y = 2.4835x, wherein the model R2 = 0.9546. In the present invention, a new impurity in procaine penicillin is recognized, which plays an important role in the quality control of procaine penicillin.
Inventors:
ZHANG MIN (CN)
YAN ZHENGREN (CN)
WU HAIYAO (CN)
MA XIANGXIANG (CN)
HUANG JUAN (CN)
ZHOU YUMIN (CN)
GUO QIANG (CN)
YAN ZHENGREN (CN)
WU HAIYAO (CN)
MA XIANGXIANG (CN)
HUANG JUAN (CN)
ZHOU YUMIN (CN)
GUO QIANG (CN)
Application Number:
PCT/CN2022/112937
Publication Date:
June 22, 2023
Filing Date:
August 17, 2022
Export Citation:
Assignee:
NORTH CHINA PHARMACEUTICAL GROUP SEMISYNTECH CO LTD (CN)
International Classes:
C07D499/46; C07C227/42; C07C229/60; C07D499/18; G01N30/02
Domestic Patent References:
| WO2006016347A1 | 2006-02-16 |
Foreign References:
| CN114262337A | 2022-04-01 | |||
| GB659755A | 1951-10-24 | |||
| US2676961A | 1954-04-27 |
Other References:
BLICKE F F, PARKE H C, JENNER E L: "Local anestetics in the naphthalene series", JOURNAL OF THE AMERICAN CHEMICAL SOCIETY, AMERICAN CHEMICAL SOCIETY, vol. 62, 1 January 1940 (1940-01-01), pages 3316 - 3319, XP002524257, ISSN: 0002-7863, DOI: 10.1021/ja01869a012
Attorney, Agent or Firm:
SHIJIAZHUANG GUOYU PATENT TRADMARK AGENCY (CN)
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