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How to Choose API Supplier

Date: 2019-10-23
浏览次数: 103

The source of safety and effectiveness of drugs lies in the quality assurance of raw materials. When selecting suppliers that meet the criteria of supplier selection and evaluation, different selection methods are selected according to the actual procurement situation. In order to obtain the lowest procurement cost and risk, it is necessary to establish long-term cooperation with suppliers with the highest product quality.

First of all, raw material supply enterprises must pass the national GMP certification, without data integrity problems, and long-term stable supply. If you change the API vendor during production, you need to complete the change archive process.

Considering the quality of API, the following points are mainly investigated.

1、 Purity

According to the Pharmacopoeia method, the purity of API meets the requirements. If the formulation company has more stringent internal control standards, it must select qualified API according to this standard.

If there are isomers in API, we need to test whether the optical purity can meet the requirements. Because the isomers of API may have different chemical properties, some of them are even toxic.


2、 General inspection items

General inspection items include pH, chloride, sulfate, moisture, solution transparency, heavy metal, arsenic salt, drying loss, etc. Almost all of them were detected by pharmacopoeia.

3、 Impurity

The test items to be evaluated are mainly determined according to the technical requirements of Pharmacopoeia and pharmaceutical enterprises in various countries.

Due to the different production process and storage conditions of API, different suppliers will produce different impurities and their contents in the process of API preparation and storage. Such as raw materials, intermediates, polymers, by-products, degradation products, etc.

4、 Granularity

The particle size of API will affect the dissolution rate of the preparation, and then affect the dissolution and concentration of the drug in vivo. According to the properties of the drug and the requirements of the preparation process, select the appropriate drug size to ensure the consistency of the particle size distribution batch. Especially for the preparation of oral solid preparations or the suspension of insoluble raw materials, particle size control is very important.

5、 Crystal form

Because many drugs are polymorphic. Moreover, due to the different crystal form of the substance, its physical properties will be different, which may have an impact on the bioavailability and stability of the drug. Due to the different preparation process, the same compound may produce different crystal forms. Other storage or transportation conditions can also affect the crystal form of the compound, for example, under different temperature, light and humidity conditions, the crystal form of the compound will change with water loss or absorption.

In most cases, it is necessary to ensure that the crystal form of the drug substance is the same as that of the original research crystal form abroad. If there is no Pharmacopoeia record, it should be compared with the original product by PXRD, DSC, IR and other means to ensure the accuracy and consistency of API crystal.

6、 Patents

Whether the production process used for API adopts the patented process and whether the target sales area has patent protection.

The quality of API has a direct impact on the safety and effectiveness of drugs, so the selection of API suppliers must be cautious. In addition to the above quality index inspection, if necessary, the small batch samples provided by the main material suppliers shall also be carried out, and the stability of the trial production drugs shall be checked to ensure the reliability of the source.

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