Insulin Injection

Insulin injection has two key excipients: glycerin and m-cresol. The quality of these two excipients will seriously affect the final stability of the formulation.

Glycerin
The common glycerin on the market is vegetable glycerin, many of which are by-products of biodiesel. These glycerin products are inexpensive and therefore have good cost performance. But compared with synthetic glycerin, their defects are also extremely obvious. The nature of vegetable glycerin is not stable enough, and it will gradually release many aldehydes and ketone impurities with the change of external temperature and time. These aldehyde and ketone impurities are the main reasons for the failure of the stability test of the preparations.

The synthetic glycerin provided by us avoids the impurities that are difficult to distinguish from the various components of vegetable glycerin, especially aldehydes and ketones impurities from the production process, so the preparation’s stability are guaranteed from the source of excipients.

Our glycerin has obtained the registration number of the National Medical Products Administration (NMPA, i.e. formerly CFDA).

M-cresol
Insulin injections are protein drugs, and the protein environment is a paradise for bacteria and various microorganisms, which is easily contaminated and causes the risk of injection infections to increase exponentially. Both the European and US Pharmacopoeia emphasize that multi-dose or multiple-use injections must be added with bacteriostatic agents. The Chinese Pharmacopoeia 2015 also recommended “adding appropriate bacteriostatic agents” to ensure the safety of injections used multiple times and avoid the risk of bacterial contamination. Therefore, the bacteriostatic agent as the main excipient in sterile injection, its quality will directly affect the safety of injections.

M-cresol is a common bacteriostatic agent for insulin injection. Unlike most m-cresols currently on the market that are extracted from coal tar, the m-cresol we provide are made using a unique global synthesis process route (chlorotoluene hydrolysis method). Therefore, similar to glycerin, we control the content of impurities and endotoxins from the beginning of the production process. In addition, in storage and transportation, we use argon protection to prevent the product from contacting with oxygen. Therefore, GenCloud’s m-cresol can be stored at room temperature for a long time without discoloration, and it will not produce new unknown impurities.

Our m-cresol has obtained the registration number of the National Medical Products Administration (formerly CFDA).

Stability study
The use of GenCloud’s glycerin and m-cresol can effectively help the formulated products pass long-term stability studies. For glycerin and m-cresol, we can provide a 24-month stability study report. The validity period of glycerin and m-cresol can reach 24 months at room temperature.

HPLC chromatograms of drug samples prepared with different m-cresols and the original research drug (click to enlarge)
  • Green curve: m-cresol of GenCloud
  • Black curve: m-cresol of other brands
  • Red curve: the original drug