New Drug Approvals

Home » Regulatory » Revised Ph. Eur. Chapter on Raman Spectroscopy introducing PAT

Revised Ph. Eur. Chapter on Raman Spectroscopy introducing PAT

DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO .....FOR BLOG HOME CLICK HERE

PAYPAL DONATIONS

ORGANIC SPECTROSCOPY

Read all about Organic Spectroscopy on ORGANIC SPECTROSCOPY INTERNATIONAL 

Categories

Blog Stats

  • 1,301,135 hits

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 1,773 other followers

add to any

Share

The revised General Ph. Eur. Chapter on Raman Spectroscopy (2.2.48) comes into operation on April 1, 2016. The Chapter now includes hand-held devices and adaption to PAT purposes. Find out more about the revised  Ph. Eur. Raman Spectroscopy chapter.

http://www.gmp-compliance.org/enews_05181_Revised-Ph.-Eur.-Chapter-on-Raman-Spectroscopy-introducing-PAT_15153,15386,Z-PDM_n.html

The revision of the General Ph. Eur. Chapter on Raman Spectroscopy (2.2.48) comes into operation on April 1, 2016.

The revised Chapter has been published in Ph. Eur. Supplement 8.7. It has been completely rewritten to include now available handheld devices and adaption to Process Analytical Technology (PAT). Raman Spectroscopy has received more and more attention in pharmaceutical industry. Hand-held instruments are suitable for rapid identification purposes for example in the incoming goods control of raw and packaging materials.

Hand-held instruments require different tolerances for wavenumber scale verification than benchtop models. Therefore, an inter-laboratory study was organized and the results have been published in a corresponding paper titled “Rationale for the update of the European Pharmacopoeia general chapter 2.2.48. Raman Spectroscopy” in Pharmeuropa Bio & Scientific Notes 2015.

In addition, the chapter has been revised to focus more on the potential use of Raman Spectroscopy in a PAT environment. Raman Spectrometry is increasingly used for PAT and chemical imaging applications. Therefore, a chapter on Chemical Imaging is also under elaboration. The draft chapter on Chemical Imaging will be published for public consultation in Pharmeuropa 28.2 (April 2016).

For more information please visit the Newsroom on the EDQM website

///////////////Raman Spectroscopy,  PAT


1 Comment

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Paypal Donate

DR ANTHONY CRASTO

Follow New Drug Approvals on WordPress.com

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 1,773 other followers

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 29 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 29 year tenure till date Aug 2016, Around 30 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 25 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 13 lakh plus views on New Drug Approvals Blog in 212 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

Personal Links

View Full Profile →

TWITTER

bloglovin

Follow my blog with Bloglovin The title of your home page You could put your verification ID in a comment Or, in its own meta tag Or, as one of your keywords Your content is here. The verification ID will NOT be detected if you put it here.
%d bloggers like this: