Last week, the registration number of hydroxyethyl ester and hydroxyphenyl butyl ketone of Gedian Renfu Pharmaceutical Excipient Co., Ltd. was published on the CDE original auxiliary package registration platform.
With the registration number of hydroxyphenylethyl ester and hydroxyphenyl butyl ester, Hubei Getian Renfu Pharmaceutical Excipients Co., Ltd. is also the first pharmaceutical excipient enterprise with 4 products of hydroxybenzamide. Under the joint efforts of the company's R&D department and the registration department, the company completed the research and development of four products of hydroxyphenyl esters, the pilot scale, stability investigation, registration data writing, etc. Now these four products are already in the CDE original package. Publicity was made on the registration platform and multiple related preparations were under technical review.
Hydroxyphenyl ester is obtained by reacting p-hydroxybenzoic acid with an alcohol. The antibacterial activity of hydroxyphenyl esters increases as the length of the alkane chain increases. Methyl ester has the lowest antibacterial activity and butyl ester is the highest. The combined use of hydroxyphenyl esters enhances antibacterial and antiseptic activity due to synergistic effects. 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.
For better product quality, Gedian Renfu Accessories Co., Ltd. controls product quality from three aspects. The first is the control of the quality of the raw materials, that is, the quality of phenol and p-hydroxybenzoic acid is strictly controlled. Secondly, the desalting step is added to the final synthetic process to reduce the effect of salt impurities on the hydroxyphenyl ester products. Finally, strict internal control standards were formulated, and specific test items were formulated and strictly controlled according to impurities and reaction by-products that may be introduced in the process.
Quality control of hydroxyphenyl ester bacteriostatic agents: https://mp.weixin.qq.com/s/3GmuLbJwCdFoRaQb82H7oA (direct link to previous article)
In the next few months, we will also submit benzyl benzoate (for injection), castor oil (for injection), sesame oil (for injection), peanut oil, sesame oil and other products on the CDE original package registration platform. Research data. It is believed that Hubei Gedian Renfu Medicinal Accessories Co., Ltd. will have more and more high-risk accessories products. To meet the production and research and development needs of domestic pharmaceutical companies, to serve the re-evaluation of injections, to provide more choices for pharmaceutical companies!