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Selection of quality research items and preliminary determination of methods: It can be called the preliminary establishment of draft quality standards (this work should be completed before the compatibility test of excipients)
1.
Based on the product quality standards inquired (original research standards, domestic first imitation standards, pharmacopoeia standards) and the requirements of the pharmacopoeia for specific dosage forms, the draft quality standards are determined
For the items included in the national drug standard, the testing method included in the standard should be considered first
Judgment criteria: system applicability, resolution, effective detection, precision and reproducibility when there is an impurity reference substance
3.
2.
4.
Quality comparative study (pilot product)
Quality comparison research is an important method to judge the quality "consistency" or "equivalence" of generic drugs and generic drugs.
1.
Generally, the method of comparing the dissolution curves in four dissolution media (PH1.
Formulated based on the results of comparative studies and stability studies
1) On the basis of national drug standards, the necessary testing items can be added with reference to foreign pharmacopoeia and references.
2) Detection method: If the new method has no obvious advantages compared with the method contained in the national drug standard, it is recommended that the method contained in the national drug standard is still adopted because the national drug standard has been verified by multiple units for a long time
.
3) Limits: When there are multiple methods for reference, the establishment of limits follows the principle of “higher or lower”
.
4) Separately formulate shelf life standards and release standards, namely registration standards and internal control standards, and write them into application materials
.
