Validation of Analytical Procedures: Graphic and Calculated Criteria for Assessment of Methods Linearity in Practice

by N. A. Epshtein
Published 2019-05-01

CHROMATOGRAPHIC SYSTEM SUITABILITY TESTING: INFLUENCE OF CORRECTION FACTORS AND LATE ELUTING PEAKS OF IMPURITIES ON THE REQUIREMENT FOR THE SIGNAL-TO-NOISE RATIO (REVIEW)

by N. A. Epshtein
Published 2019-02-01

Validation of Chromatographic Methods: Checking the Peak Purity and the Specificity of Methods with Diode Array Detectors (Review)

by N. A. Epshtein
Published 2020-08-01

Transfer of Impurities Determination Methods: Comparative Testing, Validation, Acceptance Criteria (Review)

by N. A. Epshtein
Published 2021-05-01

INTERMEDIATE PRECISION DETERMINATION AT VALIDATION OF METHODS IN PHARMACY

by N. A. Epshtein
Published 2019-01-01

On acceptable values of disregard limits for impurities and signal-to-noise ratio when checking chromatographic system sensitivity

by N. A. Epshtein
Published 2018-02-01

ABOUT STRESS EXPERIMENTS BY DEVELOPING / IMPROVING ANALYTICAL METHODS AND TECHNOLOGY OF DRUG SUBSTANCES AND MEDICINES

by N. A. Epshtein
Published 2019-01-01

VALIDATION OF CHROMATOGRAPHIC METHODS: ROBUSTNESS INVESTIGATION WITH USE OF EXPERIMENTAL DESIGN

by N. A. Epshtein
Published 2019-01-01

INVESTIGATION OF ROBUSTNESS AT VALIDATION OF HPLC AND UPLC METHODS: A MODERN APPROACH INCLUDING RISK ANALYSIS

by N. A. Epshtein, V. L. Sevastianova, A. I. Koroleva
Published 2019-01-01

RECOMMENDATIONS OF THE EUROPEAN PHARMACOPOEIA «ADJUSTMENT OF CHROMATOGRAPHIC CONDITIONS» AND THEIR RESTRICTIONS FOR THE METHODS OF IMPURITIES DETERMINATION

by N. A. Epshtein, V. L. Sevastianova, A. I. Koroleva
Published 2019-01-01