Publicity: Ethyl paraben and butyl hydroxyphenyl ester CDE registration numbers have been publicized

Last week, the registration numbers of ethyl hydroxybenzoate and butyl hydroxybenzoate of Gedian Renfu Pharmaceutical Accessories Co., Ltd. were publicized on the CDE raw and auxiliary package registration platform.

With the public announcement of the registration numbers of ethylparaben and butylparaben, Hubei Gedian Renfu Pharmaceutical Accessories Co., Ltd. is also the first pharmaceutical accessories enterprise in the country with 4 product registrations of ethylparaben. With the joint efforts of the company's research and development department and registration department, we have completed the process of research and development, pilot scale-up, stability inspection, and registration data writing of 4 hydroxyphenyl ester products. Now these 4 products have been publicized on the CDE raw and auxiliary package registration platform, and several related preparations are under technical review.

Hydroxyphenyl esters are obtained by the reaction of p-hydroxybenzoic acid with alcohols. The antibacterial activity of the hydroxyphenyl esters increases with the length of the alkane chain. The antibacterial activity of methyl ester was the lowest, and that of butyl ester was the highest. The combined use of hydroxyphenyl esters can enhance the antibacterial and antiseptic activity due to the synergistic effect. Therefore, methyl ester, ethyl ester, propyl ester, and butyl ester are often used in combination. Widely used in cream preparations, oral solution preparations, eye drops and injections.

In order to better product quality, Gedian Renfu Accessories Company controls the product quality from three aspects. The first is the quality control of raw materials, that is, the quality of phenol and p-hydroxybenzoic acid is strictly controlled. The second is the addition of salt removal steps in the final synthesis process to reduce the impact of salt impurities on hydroxyphenyl ester products. Finally, strict internal control standards are formulated. According to the impurities and reaction by-products that may be introduced in the process, specific testing items are formulated and strict control is made.

Quality control of hydroxyphenyl ester bacteriostatic agents:https://mp.weixin.qq.com/s/3GmuLbJwCdFoRaQb82H7oA(Jump directly to the link from the previous article)

In the next few months, we will also submit research materials on benzyl benzoate (for injection), castor oil (for injection), sesame oil (for injection), peanut oil, sesame oil and other products on the CDE raw package registration platform. It is believed that the high-risk auxiliary materials products of Hubei Gedian Renfu Pharmaceutical Accessories Co., Ltd. will be more and more complete and more and more. Meet the production and R & D needs of domestic pharmaceutical companies, serve the re-evaluation of injections, and provide more choices for pharmaceutical companies!

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