Transcription of Standard Operating Procedure - Gmpsop
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Standard Operating Procedure - Gmpsop
Standard Operating ProcedureTitle:HPLCM ethod Development & validation ProcedureCopyright All rights reservedUnauthorized copying, publishing, transmission and distribution of any part of the content by electronicmeans are strictly of7 ProcedureGeneralThe validation of an analytical method is the process by which it is established that the performancecharacteristics of the method, such as Precision, Accuracy, Specificity, Linearity, Limit of Detection (LOD),Limit of Quantitation (LOQ) and Robustness meet the requirements for the intended SOP refers specifically to HPLC. However, the same principlesmay be applied to validations of othertypes of analytical reference materials with documented purity should be used to perform the optimum wavelength for a method can be found by acquiring the chromatographic data on a PDAdetector over a large wavelength range, ( 200-400nm).
types of analytical procedures. Well-characterised reference materials with documented purity should be used to perform the validation. The optimum wavelength for a method can be found by acquiring the chromatographic data on a PDA
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