搜索
Search
imgboxbg

Public notice: the benzalkonium chloride (RF40) CDE registration number has been publicized

  • Categories:Company news
  • Author:
  • Origin:
  • Time of issue:2019-11-18 14:46
  • Views:

(Summary description)Last week, the registration number of benzalkonium chloride (RF40) of Gedian Renfu Pharmaceutical Excipients Co., Ltd. was published on the CDE original auxiliary package registration platform

Public notice: the benzalkonium chloride (RF40) CDE registration number has been publicized

(Summary description)Last week, the registration number of benzalkonium chloride (RF40) of Gedian Renfu Pharmaceutical Excipients Co., Ltd. was published on the CDE original auxiliary package registration platform

  • Categories:Company news
  • Author:
  • Origin:
  • Time of issue:2019-11-18 14:46
  • Views:
Information
Last week, the registration number of benzalkonium chloride (RF40) of Gedian Renfu Pharmaceutical Excipients Co., Ltd. was published on the CDE original auxiliary package registration platform, the registration number is F20190000408. Benzalkonium chloride (RF40) is also a benzalkonium chloride product that our company can meet the 2020 Chinese Pharmacopoeia standard.
  
rf
  
Benzalkonium chloride, chemically known as dimethylbenzylalkylammonium chloride, is a quaternary ammonium compound that has good bacteriostatic action against bacteria, yeasts and fungi. As a pharmaceutical excipient, benzalkonium chloride is commonly used in ophthalmic and inhalation preparations and is a highly effective antibacterial preservative. When the alkyl chains of benzalkonium chloride are different, the bactericidal effect is also different. When the alkyl chain is C12H25, benzalkonium chloride mainly kills fungi, the alkyl group is C14H29, benzalkonium chloride mainly kills Gram-positive bacteria, and the alkyl chain is C16H33, benzalkonium chloride mainly kills Gram Grad-negative bacteria
 
rf
  
Structural formula of benzalkonium chloride
 
Recently, on the National Pharmacopoeia website, the draft of the latest quality standards for the 2020 version of the benzalkonium chloride Pharmacopoeia was published. In this quality standard, the alkyl chain ratio of benzalkonium chloride is explicitly required, wherein n-C12H25 is not less than 40%, n-C14H29 is not less than 20%, and the total amount of both is not less than 70%. Therefore, Gedian Renfu Pharmaceutical Co., Ltd. has introduced benzalkonium chloride (RF40) in accordance with the relevant quality standards according to the latest pharmacopoeia standards.
 
In the consultation draft of the 2020 version of the Pharmacopoeia quality standard for benzalkonium chloride, the method for detecting the related substances of benzalkonium chloride is also required, and it is required to control benzyl alcohol, benzaldehyde and benzyl chloride in benzalkonium chloride, among which chlorine Benzene is a genotoxic impurity. Through a long period of exploration, Gedian Renfu Pharmaceutical has formed a set of processes to reduce the content of related substances, which can reduce the content of benzyl alcohol and benzaldehyde to less than 0.01%, and the chlorinated benzyl chloride can reach undetected. Improve product quality.
 
The table below compares the quality standards for benzalkonium chloride in the 2015 Pharmacopoeia and the 2020 Pharmacopoeia.
 
project
2015 edition
2020 version of the draft
Traits
This product is white waxy solid or yellow gelatinous
This product is white to yellowish white powder, waxy solid or colorless to pale yellow gum
Alkyl composition ratio
no
n-C12H25 shall not be less than 40%, n-C14H29 shall not be less than 20%, and the total amount of the two shall not be less than 70%
relative substance
no
Benzyl alcohol ≤0.5%; benzaldehyde ≤0.15%; benzyl chloride ≤0.05%
pH, solution clarification and color, water insolubles, ammonia compounds, moisture, ignition residue, content
No change
  
 
rf
  
With the approach of the 2020 version of the Pharmacopoeia standard, Gedian Renfu Pharmaceutical has introduced the benzalkonium chloride (RF40), which meets the latest quality requirements, and has been associated with several preparations. Gedian Renfu Pharmaceuticals Co., Ltd. welcomes customers and friends to consult and understand the products.
 
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 provide more choices for pharmaceutical companies!
  
Link: Public number of hydroxyethyl ester and butyl ester last week.
 

Hubei Gedian Humanwell Pharmaceutical Excipients Co.,Ltd 

Copyright © All Rights Reserved   鄂ICP备20004225号-1        Powered by 300.cn