Standardisation and validation of analytical methods in the pharmaceutical industry.
It is suggested a general scheme for the Validation of the analytical methods and some aspects of the parameters composing it are remarked. Furthermore, the procedure for the Standardisation is briefly discussed and it is highlighted the importance of two particular aspects (the calibration of the instruments and the Standard substances) that, even though not directly related to Validation, significantly affect its results.
Fidia Farmaceutici, Abano Terme, Padova.
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Rampazzo
D002626:Chemistry, Pharmaceutical; D004345:Drug Industry / Q000592:standards*; D007558:Italy; D004364:Pharmaceutical Preparations / Q000032:analysis; D012015:Reference Standards
D004364:Pharmaceutical Preparations