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Precautions for use of standard products and procedures for use of standard products

2020-05-07 09:32:34

Standard 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. The national drug standard material is the material basis of the national drug standard, which 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 is a small edition of Bolinda to share with you the precautions for the use of standard products and the procedures for the use of standard products.


Precautions for use of standard products:


1, the newly opened standard product should indicate the opening date on the bottle, should be used according to the bottle number in turn (except for the use of the whole bottle or the sample), the same batch of standard product or working reference product must be used after the use of a bottle and then open another bottle, the standard product has been taken out during the use of the standard product is strictly prohibited to put back into the original bottle.


2, the opening and use of the same bottle of working standards should not exceed 20 times, the use of time should not exceed 1 month, the use of few times or with hygroscopic working standards should be considered when the one-time use of packaging.


 

Standard use procedure steps:


1, if there is no special circumstances, the content of the working standard product is re-marked once every six months or another newly produced sample is calibrated. When the standard product is not used temporarily, the re-marking cycle may exceed the specified period, and the re-marking is carried out before use, and it can continue to be used after passing.


2, for the work standards used in a specific market, the re-labeling can be carried out in accordance with the cycle specified by the local pharmaceutical bureau or pharmacopoeia.


3 If the standard is found abnormal or large changes in the use process, the use of the standard should be stopped, and consider adopting more stringent packaging and storage methods or shortening its re-standard period and other measures.


4. If the old benchmark standard batch number expires, the corresponding working standard calibrated with this batch benchmark standard shall be re-calibrated according to the new batch benchmark standard, and the reserve solution prepared with this batch standard shall also fail at the same time, and the new batch benchmark standard shall be re-prepared.


5, according to the requirements of the specification, if the label or the test list does not indicate the expiration date (expiration period), you can go to the website to query, such as USP, EP standard product catalog, if you can not find, the factory stipulates the expiration date of this drug, if you can not know the date of this batch of standard products, you can count from the date of receipt of the standard product.


6. For the work standard products calibrated by the provincial drug inspection and Veterinary drug inspection, the validity period (expiration period) is the same as the validity period of the product.


The above content is the introduction of the precautions for the use of standards and the procedures for the use of standards. As a measurement standard, if used in drugs, it is the standard content in the content determination. Standards include stoichiometric standards, metallurgical standards and drug testing standards.

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