European Pharmacopoeia Revises Raman Spectroscopy Chapter
The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.
In response to the increased attention on Raman spectroscopy and the development of new Raman technologies, the European Pharmacopoeia Commission has revised its General Chapter on Raman Spectroscopy (2.2.48), which will be published in Supplement 8.7.
The revised chapter, which goes into effect on April 1, 2016, updates the reference standards or reagents used to verify wavenumber scale. Indene and naphthalene have been replaced by polystyrene and paracetamol, but cyclohexane has been kept. According to a European Directorate for the Quality of Medicines & Healthcare (EDQM) press release, “Polystyrene standards are widely available and already used in practice. Paracetamol is a very relevant substance for the pharmaceutical industry: stable and easy to work with. EDQM now provides a defined Chemical Reference Substance ‘paracetamol for equipment qualification CRS’. With these three reference standards and reagents, liquid, powder and polymer materials are covered. This enables the user to choose a standard typical of the physical state of the material to be examined.”
In another revision, the commission is elaborating on the Chemical Imaging chapter. The chapter will be open for public consultation from April–June 2016.
Source:
EDQM
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
