ICH Quality Guidelines
by Q1A – Q1F Stability Q2 Analytical Validation Q3A – Q3E Impurities Q4A – Q4B Pharmacopoeias Q5A – Q5E Quality of Biotechnological Products Q6A – Q6B …
Category: Articles
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 …
How to make the standard solution
Standard solution definition : A solution that has a precisely known concentration of an element or compound. A standard solution in chemistry is one that …
COLUMN MANAGMENT
To define the HPLC column performs satisfactorily and gives reproducible results. PROCEDURE: COLUMN OPERATING AND CLEANING: On receipt of the new column put the …
Analytical Method Validation
Method Validation is the process which is established, through laboratory studies, that the performance characteristics of the method meet the requirements for its intended purpose. …