Validation of analytical methods

Analytical Methods for Cleaning Validation

Residue identification in a pharmaceutical manufacturing environment involves; the cleaner, primary ingredients, excipients, decomposition products, and preservatives. This document is intended to help with the cleaner residue identification. Residue detection method selection for cleaners can involve specific methods for specific cleaner ingredients such as; high performance liquid chromatogra...

Antibiotics Residues in Honey: Validation Procedure Honey Analytical Methods Validation

An uncontrolled used of antibiotics and sulphonamides is responsible for the presence of residues in beehive products and contributes to the problem of food safety. The optimisation of analytical methods for the detection of residues of antibacterial drugs (sulphonamides, SPs; tylosin, TL; streptomycin, ST) in honey was pursued and the methods applied to routine samples. ST was investigated by ...

Analytical Method Validation

In pharmaceutical industries, the validation of analytical methods is used to demonstrate that the method is fitted for its purpose; it must follow a plan which includes scope, performance characteristics, and acceptance limits. Analytical methods need to be validated or revalidated prior to their introduction into routine analyses (release of batch). The overarching philosophy in current good ...

Validation of an Analytical Procedure

Analytical Methods

Despite the large relative mass difference between different Ca isotopes, the isotopic variability of Ca in natural materials is relatively small. Consequently, high-precision Ca isotope analyses are required to accurately resolve Ca isotope fractionation prior to data interpretation. This chapter summarises techniques which are successfully used to digest samples and to purify different types ...