CONTROL OF STABILITY ANALYSIS RESULTS FROM THE VALIDATION METHODS ON THE EXAMPLE OF DETERMINATION OF IMPURITIES IN ETHYL ALCOHOL
The article presents the verification of stability analysis results the volume fraction of methyl alcohol in the sample of 95 % ethyl alcohol by gas chromatography with the use of control charts Shewhart in a measurement control-analytical laboratory of State budgetary institution of the Ryazan region "Center of certification and quality control of drugs". Is given formulas for calculating a criterion of Cochrane, standard deviation intermediate precision, control digit for the construction of maps. Is explained their calculation, construction and use of Shewhart charts. Proven stability results when using methods for the assessment of quality of 95 % ethyl alcohol in accordance with the requirements of normative documents. The results of these analyzes are the basis for developing a Standard operating procedure «Validation of gas chromatographic method of test of 95 % ethyl alcohol».