by maheshbhuva | May 17, 2025 | Analytical Chemistry, Analytical method development hplc,, Method validation, QMS, Quality control (QC), Wheat
According to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline Q2(R1), specificity is defined as:”Specificity is the ability to assess unequivocally the analyte in the presence of components...
by maheshbhuva | May 13, 2025 | Analytical Chemistry, Analytical method development hplc,, Method validation, Quality control (QC), Research and development (R&D)
UV development can refer to several distinct areas, primarily revolving around ultraviolet (UV) light and its applications. To provide a comprehensive answer, let’s explore these different facets:1. UV Spectroscopy Method DevelopmentThis involves creating and...
by maheshbhuva | May 12, 2025 | Analytical Chemistry, Quality control (QC), Uv
“UV analysis” most likely refers to Ultraviolet-Visible (UV-Vis) Spectroscopy. This is a widely used analytical technique that studies how substances interact with ultraviolet and visible light.Here’s a breakdown of what UV-Vis analysis...
by maheshbhuva | May 5, 2025 | Analytical Chemistry, Analytical method development hplc,, Method validation, Pharmaceutical interview,, Quality control (QC), stability
Ah, method validation planning in pharma – a cornerstone of ensuring the quality and reliability of pharmaceutical products! It’s all about demonstrating that your analytical methods are fit for their intended purpose.To get started with effective method...
by maheshbhuva | May 3, 2025 | Analytical Chemistry, Quality control (QC), stability
Out-of-Trend (OOT) in Pharmaceutical StabilityIn the pharmaceutical industry, Out-of-Trend (OOT) results refer to analytical data obtained during stability studies that, while still within the established specification limits, deviate significantly from the expected...