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Which USP General Chapters you should know as a scientist working in R&Ds of pharma industry?

 After finishing MSc or PhD in Chemistry, many Indian university students join R&Ds of pharmaceutical industries as a research scientist or analyst or chemist. It is not easy to survive in this ever-growing field, if you don't have adequate knowledge. Because always remember one thing - Knowledge is power, and it is the most powerful currency you can have to grow in your workplace.

While giving interviews for the above-mentioned relevant jobs, the candidates are asked many times whether they are aware of the USP General Chapters (GC) or not, because these are like guidelines or textbooks which we should follow while doing any analysis. Reading only about the analytical instruments or synthetic coupling reactions is not enough. I will mention here a few of the general chapters which you can go through to have a better idea of the industrial practice and to impress the interviewer to land into your desired job. 


USP GC <621> Chromatography

Reading and understanding this general chapter is a MUST. It talks about many conceptual aspects. While reading, if you can't understand anything clearly, google the terms, watch you tube videos on them, but don't leave this one.

USP GC <1469> Nitrosamine Impurities

This is the hottest topic in the pharma industry now. Before reading this general chapter, do read the basics from google. Understand this GC properly so that if interviewer asks, you can impress them with your answers.

USP GC <731> Loss On Drying (LOD)

It is one of the most important system suitability tests to estimate volatile matter in a sample.

USP GC <281> Residue On Ignition (ROI)/ Sulfated Ash

This is also a very important test to estimate the amount of inorganic impurities in a sample.

USP GC <467> Residual Solvents (RS)

Using GC Headspace technique, you can find out RS in your sample. Understand this technique.

USP GC <541> Titrimetry

Understand KF titrimetry. Understand the difference between KF vs. LOD vs. ROI

USP GC <791> pH

Effect of temperature on pH.

USP GC <761> NMR

Understanding different forms of NMR, how to separate enantiometrs and diastereomers.

USP GC <736> Mass Spectrometry

Understand LC-MS, GC-MS

And in addition -

USP GC <197> Spectroscopic Identification Tests

USP GC <232> Elemental Impurities Limits


That's it for today!







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