For a pharmaceutical researcher, the term impurity reference substance is the most familiar, and it is also an indispensable part of the drug application process. Relevant regulations indicate that if it is a reference substance specified in the pharmacopoeia, the batch number and instructions must be provided, and if it is a self-made reference substance, the content and purity calibration process must be provided. The impurity verification in drug research and analysis requires preparation or purchase of impurity reference substances.

However, when some people purchase impurity reference products, they often say that it is expensive. It is natural to have such a reaction, but do you know why the price of impurity reference products is relatively high? In fact, these are all There is a reason.

We know that the market price of a commodity is affected by market supply and demand, and there is a supporting cost price. In the impurity reference industry, the technical threshold and capital requirements are relatively high. In addition to purchasing a series of testing, calibration, and preparation equipment (most of them are imported equipment), there is also a very important part of the cost of technical research and development personnel. The educational background of personnel is generally high, and there are many masters and doctoral degrees. The cost of hiring these personnel is still relatively high. In addition, the development and customization of impurity reference materials is not done overnight, and there are many uncertain factors in the process. Many development projects eventually end in failure, which all involve cost issues.

The specific main factors are as follows:

1. The price of raw materials

The price of the raw materials needed in the process of impurity synthesis or research and development is different. Some raw materials are relatively cheap, so the price of the impurity reference substance will be relatively cheap. And some APIs are more expensive, so the prepared impurity reference substance will naturally be more expensive.

2. Degree of difficulty

Each impurity reference substance is different in the degree of difficulty in research and development and the number of chemical reaction steps, so there will be a difference in price. The higher the difficulty, the higher the price of impurity reference products with more steps.

3. Impurity purity

Impurity purity is one of the standards for testing the quality of impurity reference products. Generally speaking, in order to evaluate the quality of self-developed products, the impurity purity should be clear. The higher the impurity purity, the closer to the ideal. Therefore, when conducting impurity synthesis research and development , The higher the purity, the higher the price.

4.equipment

Impurity R&D and synthesis requires standard-qualified laboratories, complete experimental equipment and instruments, so the loss of materials, equipment and instruments is included in the price of the impurity reference substance.

5. Labor cost

The clinical development of R&D impurities requires highly educated, high-tech R&D personnel, and project-experienced management teams, etc. These are also one of the factors that affect the price of impurity reference products.

6.there will be differences in the choice of imported/domestic prices

When comparing domestic and imported impurity reference products, the price of the same product is definitely more expensive than imported products. The imported brands of impurity reference substances include American SINCO PHARMACHEM, Canadian TRC, TLC, QCC, etc.

7. Only by choosing high-quality impurity brands can we obtain impurity reference products with satisfactory prices

Why the impurity reference substance you choose is expensive? It is because you did not choose a high-quality impurity procurement platform. Only by choosing a high-quality impurity brand can you obtain a satisfactory impurity reference substance with a good price. The impurities provided by Tonghui Pharmaceutical are not only high in purity, cheap in price, and good after-sales service. They are outstanding in the impurity reference substance industry. It has a unique research and analysis method for impurity research. It is the pioneer of impurity reference substances in China and has many years of rich experience. .

In addition, Tonghui Pharmaceutical has a high-tech R&D team, which optimizes the design of drug synthesis, and simplifies the synthesis steps while ensuring the quality of impurities; plus internationally qualified CNAS laboratories and complete testing equipment to accelerate the promotion Impurity synthesis.

Today, Tonghui Pharmaceutical's business scope can provide one-stop services such as impurity reference substances, reference preparation import, imported API registration, consistency evaluation, and pharmaceutical research services, which fully assists the research and development of pharmaceutical companies and scientific research. Welcome to consult .