Development and Validation of an Analytical Procedure to Measure Residual Solvents in Betaxolol Hydrochloride
Abstract
Any pharmaceutical industry's primary goal is to consistently manufacture goods with the requiredqualities and attributes at a reasonable cost. The discovery, development, and assessment ofmedications in pharmaceutical formulations depend on the creation of a methodology. This reviewarticle's primary goal was to examine the evolution and validation of the process used for the drugfrom the beginning of formulation to the full commercial batch of product. The results must betrustworthy when an analytical method is used to generate results for the quality of samples relatedto medicine. The pharmaceutical sector has published validation policies that outline how toconduct validation, methods of validation and how the validation policy conforms to therequirements of GMP legislation. Validation is crucial to the efficient operation of pharmaceuticalcompanies. Every step of the process, from the raw material to the final product, was validated forstability. The validation parameters are described in terms of accuracy, specificity, limit of detection(LOD), limit of quantitation (LOQ), and system appropriateness testing using specific substances asan example. The method was appropriately established. The routine and stability analysis make useof every validation parameter.
Fields of Study & Subjects
Analytical Methods in Pharmaceuticals
Pharmaceutical Quality and Counterfeiting
Pesticide Residue Analysis and Safety
Publication details
- Journal / source
- Zenodo (CERN European Organization for Nuclear Research)
- Publication date
- 1 January 2026
- Language
- EN