Ok, back to the topic: Why is the impurity reference so expensive?
In fact, the price of the impurity reference product is relatively high, mainly because it will be affected by the following factors, so that the price of the impurity reference product fluctuates.
First, the price of raw materials
The price of raw materials required for the synthesis or research and development of impurities is different. Some raw materials are relatively cheap, so the price of the reference substance will be relatively cheap, and some raw materials are more expensive, so the prepared impurity reference will naturally quite expensive.
Second, the difficulty level
The difficulty of research and development of each impurity control product and the number of chemical reaction steps are different, so there will be differences in price. The higher the difficulty, the more the impurities will be.
Third, imported domestic
In the comparison of domestic and imported products, the same products, in terms of price, must be more expensive. The imported brands of impurity reference products are currently used in the United States, such as HIC, Canadian TRC, and TLC.
Fourth, impurity purity
Impurity purity is one of the criteria for testing the quality of impurities. In general, in order to evaluate the quality of self-developed products, the purity of impurities should be clear. The higher the purity of impurities, the closer to ideal, so when developing impurities. The higher the purity, the higher the price will be.
Five, equipment
The development and synthesis of impurities requires a standard qualification laboratory, a complete set of laboratory equipment, so the loss of materials, equipment and instruments is included in the price of the impurity reference.
Sixth, labor costs
The clinical development of research and development of impurities requires a highly educated, high-tech R&D personnel and a project-experienced management team. These are also factors that affect the price of impurity reference products.
