The expiry date printed on your medicines isn’t arbitrary—it’s carefully determined through rigorous stability studies to ensure the drug remains safe and effective throughout its shelf life. Here’s a breakdown of how it’s done: Step 1: Stability Studies Pharmaceutical companies test drugs under controlled conditions to monitor: These studies are performed using samples stored under…
Titration is a laboratory technique used to determine the concentration of an unknown substance by reacting it with a known substance. Here’s an overview: Types of Titration Titration Process Key Concepts Applications Common Titration Techniques Read also: Resource Person: Susmita
The calculation of peak purity in HPLC (High-Performance Liquid Chromatography) is typically performed using a photodiode array (PDA) detector, which can detect absorbance at multiple wavelengths simultaneously. Steps : Collect Spectral Data Across the Peak: During HPLC analysis, a PDA detector collects the UV-visible spectrum at different points across the peak (start, apex, and end…
As a Stability Assessor at the Egyptian Drug Authority, I frequently review CTD files, and I’ve noticed recurring mistakes in the Analytical Method Validation section. These oversights not only delay regulatory approvals but also question the reliability of the data presented. Here are some common pitfalls to avoid: 1. Incomplete Validation Reports: Failing to address…
Analytical Laboratory KPIs: Turnaround Time (TAT) Test Completion Rate: Accuracy and Precision: Instrument Uptime: Sample Rejection Rate: Quality Control KPIs: Out-of-Specification (OOS) Rate: Out-of-Trend (OOT) Rate: Deviation Rate: Corrective Action/Preventive Action (CAPA) Effectiveness: Read also: Resource Person: Rajesh Jain
Title and Identification:Including the type of test being performed, batch number, sample ID and date of analysis. Procedure Steps:Clearly outlining each step of the test method and procedures along with the references. Raw Data Entry:Areas to record experimental observations, instrument readings and raw data. Additional data prints like spectra should be attached. Calculations:Sections to perform…
Pre-Validation Requirements: Specificity: Linearity and Range: Accuracy and Precision: Robustness: Limit of Detection & Quantitation: System Suitability: Observations and Deviations: Analytical test method validation is a cornerstone of scientific accuracy and precision. Read also:
These tests are designed to confirm the identity of the active pharmaceutical ingredient (API) and other components in a drug formulation. The identification of pharmaceuticals is a fundamental step in quality control, as it helps prevent errors in manufacturing and ensures that the final product meets the required specifications. Here are some common identification tests…
