Publicity: Benzalkonium chloride (RF40)CDE registration number has been publicized

Last week, the registration number of benzalkonium chloride (RF40) of Gedian Renfu Pharmaceutical Accessories Co., Ltd. was publicized on CDE Raw and Auxiliary Package Registration Platform, with the registration number of F20190000408. Benzalkonium chloride (RF40) is also a benzalkonium chloride product launched by our company that can meet the 2020 edition of Chinese Pharmacopoeia standards.

Benzalkonium chloride (Benzalkoniumchloride) chemical name is dimethyl benzyl alkyl ammonium chloride, is a quaternary ammonium compound, bacteria, yeast and fungi have a good antibacterial effect. Benzalkonium chloride, as a pharmaceutical excipient, is commonly used in eye and inhalation preparations, and is an effective antibacterial preservative. When the alkyl chain of benzalkonium chloride is different, the bactericidal effect is also different. When the alkyl chain is C12H25, benzalkonium chloride mainly kills fungi, when the alkyl chain is C14H29, benzalkonium chloride mainly kills gram-positive bacteria, and when the alkyl chain is C16H33, benzalkonium chloride benzene mainly kills gram-negative bacteria.

Structural formula of benzalkonium chloride

Recently, on the official website of the National Pharmacopoeia Commission, the draft of the latest quality standard for benzalkonium chloride 2020 edition pharmacopoeia was publicized. In this quality standard, the alkyl chain ratio of benzalkonium chloride is clearly required, of which n-C12H25 shall not be less than 40%,n-C14H29 shall not be less than 20%, and the total amount of both shall not be less than 70%. Therefore, according to the latest pharmacopoeia standard, Gedianrenfu medicine auxiliary has introduced benzalkonium chloride (RF40) that meets the relevant quality standards.

In the draft for soliciting opinions on the quality standard for benzalkonium chloride in the 2020 edition of the Pharmacopoeia, the detection methods for related substances of benzalkonium chloride are also specified, requiring the control of benzyl alcohol, benzaldehyde and benzyl chloride in benzalkonium chloride, of which benzyl chloride is a genotoxic impurity. Through a long period of exploration, Gedian Renfu medicine auxiliary has formed a set of technology to reduce the content of related substances, which can reduce the content of benzyl alcohol and benzaldehyde to less than 0.01%, and the genotoxic impurity benzyl chloride can reach undetected, thus improving the product quality.

The following table compares the quality standards of benzalkonium chloride in the 2015 and 2020 pharmacopoeia drafts.

Project	2015 version	2020 version of the draft for comments
Traits	This product is a white waxy solid or yellow colloidal body	This product is white to yellowish white powder, waxy solid or colorless to light yellow jelly
Alkyl composition ratio	None	The n-C12H25 shall not be less than 40%, the n-C14H29 shall not be less than 20%, and the total amount of the two shall not be less than 70%
Related substances	None	Benzyl alcohol ≤ 0.5%; Benzaldehyde ≤ 0.15%; Benzyl chloride ≤ 0.05%
pH, clarification and color of solution, water insoluble matter, ammonia compound, moisture, ignition residue, content	No change

With the approach of the 2020 edition of the pharmacopoeia standard, Gedianrenfu medicine auxiliary has introduced benzalkonium chloride (RF40) that meets the latest quality requirements, and the product has been associated with several preparations. Ge shop people welcome the majority of customers and friends to consult and understand the product.

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 and provide more choices for pharmaceutical companies!

Link:Last week's public number of ethyl hydroxybenzene and butyl esters.

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