Study on the Effect of Repaglinide Raw Materials from Different Sources on the Stability of Preparations
Objective:To compare the effects of repaglinide raw materials from different sources on the stability of repaglinide tablet preparations.Methods:Using 3 different APIs,the production of repaglinide tablets was carried out and the stability test of tablets was carried out.The relevant substances,L-isomer methods and the 2020 edition of the Chinese Pharmacopoeia content determination method were used to test the key items of the stability of repaglinide tablets,and the results were compared and analyzed.Results:There was no significant difference in the stability results of repaglinide tablet preparations produced by three different sources of repaglinide raw materials.Conclusion:APIs from different sources have the same synthesis process route and the same impurity profile,which have no effect on the stability of the produced preparations.
repaglinide raw materialsdifferent sourcesrepaglinide tabletsstabilityeffect
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