We are pleased to announce that Dr Luca Gramaccioni, General Site Manager at Kymos Italian Site Pharmaprogress, has been asked to share his analytical experience on nitrosamines in yet another webinar – this time the AFI Symposium 2021 hosted by the Associazione Farmaceutici Industria on September 24th. In anticipation for the event, he and Dr Massimo Bartolacci, Pharmaprogress’ nitrosamine expert, share their insight into how regulatory requirements have evolved since the classification of nitrosamines as probable human carcinogens back in 2019:
“At first the concentration limit of 0.03 ppm for each nitrosamine was identified by the authorities as the limit to demonstrate the absence of nitrosamine and therefore that limit became everybody’s focus.” Dr Bartolacci explains. “Over time, however, the requirement to link the specification limit for nitrosamines to the MDD (maximum daily dose) of the active ingredient (API) became mandatory, thus causing a differentiation of the specification limits and calling for their overall reduction.”
In addition, under current guidelines, if manufacturers are able to prove that nitrosamines do not exceed 10% of the limits of specification, they are exempt from routine nitrosamines testing in their manufacturing quality control analysis. At this point API work is completed or near completion and companies are moving to step 2 of nitrosamine determination where activities are centred on the finished project and, most importantly, more sensitive analytical methods are required to perform these analyses. Fortunately, Dr Bartolacci’s team was up to the challenge:
“We recently developed a method with a lower limit of 0.1 ppb, a new in-house record which illustrates our commitment to keep pushing the envelope.” Dr Bartolacci states. “This adaptability to meet lower limit levels, combined with our extensive nitrosamine experience and our well provided facilities, with both LC-MS/MS and HS-GC-MS instruments available for nitrosamine work, has made it possible for us to adapt to changing regulatory and analytical requirements and ultimately satisfy our customer needs with the same quality and responsiveness they have come to expect from us in the past.” Dr Bartolacci concludes.
No wonder that the Pharmaprogress team has been invited to participate at the AFI 2021 Symposium. Dr Luca Gramaccioni’s talk, titled “First-hand experience addressing analytical challenges of nitrosamines determination” will be part of the “Nitrosamines: Where we are” webinar.
For more information about the webinar click here.It will be possible to register until 5.00 pm on the day before the webinar. Registration is free for AFI Members and staff from AIFA or the Higher Institute of Health and the Ministry of Health. Registration fees for non-AFI members are €50.0 + VAT 22%.
Learn more about our Elemental, nitrosamines and other impurities testing and about our Quality control of small molecules and Quality control of biologics and biosimilars.
Contact us or send us an email to commercial@kymos.com.
