ICH Q1 QUALITY STABILITY GUIDELINE
by (1). Q1A (R2)-Stability Testing of New Drug Substances and Products (2). Q1B-Stability Testing ( Photostability Testing of New Drug Substances and Products). (3). Q1C-Stability Testing …
ICH Quality Guidelines
Q1A – Q1F Stability Q2 Analytical Validation Q3A – Q3E Impurities Q4A – Q4B Pharmacopoeias Q5A – Q5E Quality of Biotechnological Products Q6A – Q6B …
Purified Water
Water is life, and ensuring that the water we consume is pure and clean is vital for our health and well-being. With increasing concerns about …
Dissolution Medium Identification for Method Development
Disso media identification is a critical aspect in the development of dissolution testing methods, especially for pharmaceuticals. The goal of dissolution testing is to simulate …
Top 10 Pharmaceutical Company in india
Below, we have sorted India’s top 10 pharma companies listed on the NSE according to their market caps, 1. Sun Pharma Sun Pharmaceutical Industries Limited …
Planning and Procedure for Regulatory Audits
Different types of inspections are conducted by Regulatory Agencies. Following are the various types of inspections conducted periodically by Regulatory Agencies.
Gap Analysis For Regulatory Complience
Check the list of the documents of the respective department and identify the areas to be analyzed for gap, according to the criticality of the …
How To Determine A Buffer For Mobile Phase In Chromatography
Table Of Contents (1): Why Control pH? (2): Practical Implications (3): Controlling pH (4): What About LC-MS? (5): Just Interested in Low pH (6): Or …
How to Measure Noise
This Edition of HPLC solutions is about the different ways to measure noise in HPLC. This installment of HPLC Solutions begins a series on different …
Operation of Reverse Laminar Air Flow
To lay down the procedure for operation of Reverse Laminar Air Flow. 2. Scope The SOP is applicable to operation of RLAF in sampling . …