Application Of NIR And RAMAN Technologies To Identify Medical Excipients

According to current Chinese GMP, all raw materials and excipients used in theprocess of production in pharmaceutical enterprises should be identified at first insome of suitable ways. This is necessary to ensure the correctness of material in eachpackage, and it is a useful way to avoid confusion and mistakes. If we use traditionalphysical chemical method or classical molecular spectra instruments to have this kindof testing, we have to add personnel to complete. We want to find a better way tosolve this problem by using NIR and RAMAN spectrograph, which is a rapid, damagefree and effective method to save sample and testing cost.We studied how to create a model method of NIR and RAMAN, and validated itssuitability to Indapamide. We practiced its practicability, control testing, negativetesting, effective from different suppliers and package materials, repeatability betweenseveral batches. Finally the compare result between new instrument and traditionalone show their respective peculiarity. We can judge if NIR and RAMAN can be usedin this field.As for the testing results, portable NIR or RAMAN can create valid standardtesting model, which has high practicability, wide usability and good repeatability, forIndapamide. It can be used to identify a great deal of materials with same type ofpackaging from different suppliers. Indapamide and relative materials can bedistinguished well. The checking results in different batches and packages are bothcoincident between NIR, RAMAN and traditional IR. So we can come to theconclusion that they can substitute for IR to identify medical materials in the processof reception inspection.