Reference products refer to the standard substances used in the national drug standards for identification, inspection, content determination, impurity and related substance inspection, which is an integral part of the national drug standards. It is a special measuring tool used to check the quality of drugs; It is the benchmark for measuring drug quality; It is also used as a material standard for calibration of test instruments and methods. The following small series to introduce to you the points to pay attention to when the reference product calibration method.

Points to pay attention to when calibration method of reference products:

1. The dosage of the test product should meet the requirements of titration accuracy (about 20ml of titration liquid consumed).

2, the determination of titration end point should be clear, and the titration curve should be provided; If the indicator method is selected, the sensitivity of color change should be considered, and the end color should be calibrated by potentiometric method.

3. In order to exclude the influence of impurities mixed with other reagents on the determination results, or to facilitate the calculation of residual titration, the method of "correcting the titration results with blank test" can be used.

4, to give the titration degree (using four significant digits) derivation process; The calibration results shall be based on the results of no less than 15 groups of determination results from more than 3 laboratories, after statistical analysis, the results of removing outliers and suspicious values, and the reliability limit shall be reported.

The above content is the introduction of the main points to pay attention to when the calibration method of reference products, there are many enterprises in fact, the management of reference products is not very in place, especially those enterprises that are not very familiar with the reference products themselves, often prepare the reference products into a higher concentration of reserve liquid, but fail to examine its stability and storage period. Some will be opened and opened before the control products together, there is no special instructions on the package.