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...
by maheshbhuva | May 1, 2025 | Analytical Chemistry, Quality control (QC), stability
To ensure proper management and traceability of samples undergoing stability studies in a pharmaceutical setting in Surat, Gujarat, India, the labels on these samples must contain specific information. These labels are critical for identifying the samples, their...
by maheshbhuva | Apr 30, 2025 | Analytical Chemistry, Quality control (QC), stability, wet lab
1. Charging Samples to a Stability Study (Initiation):In the pharmaceutical industry, “charging” samples to a stability study refers to the process of formally placing representative samples of a drug substance or drug product into controlled storage...
by maheshbhuva | Apr 27, 2025 | Analytical Chemistry, Heavy metal, Quality control (QC)
Method B in heavy metal testing is used for substances that do not yield clear, colorless solutions when tested under Method A. It involves reacting the sample with hydrogen sulfide or sodium sulfide to form colored metal sulfides, which are then compared to a...
by maheshbhuva | Apr 26, 2025 | Analytical Chemistry, Analytical method development hplc,, Quality control (QC)
heavy metals in a substance. It involves reacting the substance with hydrogen sulfide (or sodium sulfide) to produce colored heavy metal sulfides, which are then compared to a standard lead solution. The test ensures that the sample does not exceed a specified heavy...
