The Central Inspection Institute's regulations and batches on reference substances

2026-03-27 10:24:45
      
  The new batch comes out, is the old batch unusable?
  In principle, yes.Central Inspection InstituteConduct quality monitoring of the stored reference materials on sale. Once it is found that the quantity value is not applicable, a stop-use notice will be immediately issued on the website of the China Inspection Institute. If the previous batch of reference materials of the current batch of a certain variety has not issued a stop-use notice or announced the effective use period, it will be stored according to the conditions specified in the manual. Generally, it can be used normally within 6 months. It is recommended that users buy as they use or according to the production and inspection plan. Do not stock up in large quantities in advance, because once the new batch number starts to be supplied to the outside world, our hospital will no longer conduct quality monitoring on the old batch number. If the user continues to use it, please verify its characteristic value and applicability by yourself.
  Most of the national drug standard substances do not specify a specific valid period, why?
  Referring to the practice of similar international institutions, most national drug standard substances do not have a valid period, but continuously monitor the quality stability of the currently valid batches on sale. Some national drug standard substances have a valid period, please refer to the marked valid period.
  Where can I download the National Drug Inspection Institute Standard Product Catalog?
  Please view the live reference substance catalogue on the catalogue inquiry link page on the left, or click here to download the latest version of the reference substance catalogue (June 29, 2018 version).
  Is XXX standard product in stock?
  Please search for a variety on the directory inquiry link page on the left.reference materialWhether it is in stock. For varieties that are not available yet, please browse the Internet from time to time. It is difficult to provide the specific availability time accurately.
  May I ask when the new batch of reference substances will be issued by XXX Central Inspection Institute?
  Generally speaking, the Central Inspection Institute will formulate a production plan for the transfer of reference materials in advance to ensure the continuous supply of reference materials. However, there are still individual cases where the difficulty of obtaining raw materials or other force majeure effects may cause the production of new batches to lag behind. You can often check the catalog of reference materials or contact customer service to get the latest information on new batches.
  What are the uses of national drug standard substances?
  Generally speaking, the purpose of national drug standard substances is to calibrate measurement systems, evaluate measurement methods, identify or check the characteristics of test drugs, or assign values to test drugs in drug quality tests. If you use it for other purposes such as scientific research, please prove your suitability yourself.
  Why can't I see the price of reference substances on the catalog inquiry page?
  The price of reference substances is not displayed on the catalog inquiry page, but the price will be displayed on the ordering platform page. You can check the price of reference substances online after logging in to the ordering platform.
  Can you provide quotation, purchase contract or product COA (product quality inspection report) and three certificates?
  We will not provide these documents for the time being.
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