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The Chinese Pharmacopoeia uses high-performance liquid chromatography for detection of more than 2,000 varieties.
In fact, it is not just domestic HPLC that does not exist.
Of course, China is not unable to produce HPLC.
The logic of drug quality work
The logic of drug quality workThe quality of drugs is related to the health and lives of patients.
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For example, suppose I am going to put a pack of rubber stoppers for sterile injection production in the middle of the sterilizer and sterilize it at 121°C for 30 minutes.
System defects of domestic instruments
System defects of domestic instrumentsBefore the implementation of the 2007 version of the Drug Administration Law, there was a crazy period of domestic drug supervision, when a large number of drug registration materials with doubtful data integrity were submitted to the drug administration department.
In 2009, CDE issued the chromatographic data workstation and chromatographic data management requirements based on the problems found in the centralized review.
Several difficulties in returning to mainstream pharmaceutical companies
Several difficulties in returning to mainstream pharmaceutical companiesThe next decade is the loss of domestic HPLC, struggling in industries with relatively low compliance requirements such as agriculture, forestry, animal husbandry and fishery.
Domestic HPLC has been lost for ten years, but it is more difficult to re-enter the pharmaceutical companies above designated size than it was 10 years ago, because domestic HPLC still carries an untrustworthy burden.
According to the above fixed logic, suppose I am going to use HPLC to test the quality of a batch of drugs according to the prescribed standards.
Even more frightening is that even if I have 100 imported HPLC, as long as there is a domestic HPLC, the credibility of the system will be diluted, because in extreme cases there is a risk of using imported HPLC for normal testing after “pre-testing” with domestic HPLC.
Another difficulty for domestic HPLC to return to the pharmaceutical industry is the stronger the stronger the Matthew effect.
