Reference products as a laboratory is often used in the substance, its use is very wide, because the number of reference products is very large, so in the selection, we need to have a strict standard, for not used out of the reference products need a what kind of preservation method? What should I pay attention to when using it? These are the users are very concerned about the problem, the following small series to give you a detailed description of the control product preservation methods and use precautions and other issues.

Storage method of reference products:

1, the control products should be properly stored according to the conditions specified in the instructions, generally stored in a dry and cool place, some control products such as vitamin E need to be kept at low temperature away from light. Pay attention to the use period of the reference products, expired, deteriorated reference products should not be used again. It is recommended to use up in a short time after opening the bottle, to avoid long-term use after opening the bottle, at the same time, in the process of repeated use should try to avoid the decomposition of the control product, pollution or moisture absorption.

2, the use of CCI reference products, should be strictly in accordance with the instructions. Under normal circumstances, the reference products for identification and inspection cannot be used for content determination. When using the reference product for infrared identification, attention should be paid to the difference in crystal shape between the sample and the sample. If necessary, the sample and the reference product can be recrystallized by the same method. For example, ampicillin sodium has a variety of different crystal forms, which can be determined by recrystallization of the sample and the control product with acetone to ensure that the crystal forms and infrared spectra of the two are consistent.

3. The reference product or international reference product provided by the China General Institute for Drug Inspection is the legal reference product, and the raw materials standardized by the legal reference product can be called the secondary reference product or the working reference product. In order to save costs, drug manufacturers may use working reference products for routine inspection, but only legal reference products must be used for drug inspection, and the inspection report issued by the manufacturer shall have legal effect.

4, unless otherwise specified, the reference product should be used to determine the moisture content of the appropriate method, according to the dry product (or anhydrous substance) calculation after use, otherwise it will cause high content determination results. Heat stable control products can be used directly after drying; For the thermal unstable control product, another part can be taken at the same time for drying weight loss, after deducting moisture. In addition, if the reference product contains crystal water or salt base, attention should be paid to its conversion when used.

Precautions for use of reference products:

Due to the wide range of uses of reference products, some research and development personnel use the same reference product for different purposes. In actual use, it was found that some researchers mixed the same reference product, the reference product for content determination was used for identification, and the reference product for identification was used for content determination. The result of the experiment is inaccurate.

In addition, it should be noted that the stability and quantity of the selected drug reference material should meet the needs of the entire experimental plan, and the reference material that has exceeded the stable period cannot be used. In addition, the USP control products do not have an expiration date, but the USP will publish the latest batch of control products at any time in the USP forum every 2 months, and the control products are constantly monitored to ensure the effectiveness of the control products in the USP laboratory.

The above content is the introduction of the storage methods and precautions for the use of reference products, reference products occupy a very important position in drug research, so for the use of reference products in drug testing, the corresponding staff should be careful, in strict accordance with the relevant process operation, only the correct use of them, in order to play its important role.