Thank you very much. I am glad to join this scientific expert group dealing with Nitrosamines issues.
Hello to every one in this group.
My names are Felchism Apolnary, Pharmacist with Masters degree in Biotechnology Innovation and Regulatory Science.
I working with Medicines Regulatory Authority of Tanzania (TMDA). Technically I am assessor of medicinal product dossiers.
I should also mention that I am a WHO consultant/technical advisor participating in the WHO – Prequalification Team - Medicines for assessment for Active Pharmaceutical Ingredient (API).
@Felchism1 Welcome to Nitrosamine Exchange. I hope you find this community helpful and insightful as you progress your Nitrosamine journey.
Feel free to participate in the discussions that we host on daily basis, and share information that you find could benefit the community.
Welcome!
@Hermine401 Welcome to Nitrosamine Exchange Community. Your experience on Nitrosamines Risk Assessment will be invaluable for all the discussions we host here. Please feel free to reply and provide your expert views on the community.
Welcome!
@DPandey Welcome to Nitrosamine Exchange. The hunt for a robust analytical method is a daily quest here in the community. Your experience and insight are more than welcome in any of our analytical discussions, so feel free to participate and hit reply when you see necessary. You have now thousands of chemists working on similar challenges that you and your team are facing!
Welcome
Hello everyone. I am Dr. Kiran, working as a senior manager in MSN Laboratories in API R&D department since 10 years. I am very glad to be part of this scientific community. Looking ahead for an active participation with you all.
Hi, My name is Nagendar Reddy Purmandla. I am working at Honour R&D facility a Hetero group of company, Hyderabad, India. I have total experience of 22years in Analytical development, especially on Mass and NMR spectrometry and working on GTI’s and NDSRI of our API and DP . Happy to be part of this group.
I am Vivek Dubey, serving as a Senior Scientist at Daicel Chiral Technologies in Hyderabad, bringing with me 16 years of expertise in the Analytical field. My primary focus lies in characterization, with the past 4 years dedicated to assessing Nitrosamine Impurities in API and Drug products.
I am delighted to join this community, eager to both learn and contribute.
Hola, mi nombre es Marleby García y soy Bioquímica. Mi trabajo es estar al frente de pruebas de cuantificación de nitrosaminas en México siguiendo la farmacopea mexicana. Tenemos 2 métodos analíticos validados con alcance a 6 nitrosaminas. Hemos evaluado sartanes, metformina entre otros.
Hello, my name is Marcin Kublicki and I am an organic chemist. I have been working for the last 4 years in the pharmaceutical consulting company SciencePharma as a CMC consultant. Aside from nitrosamine risk assessments, I work on pharmaceutical dossier gap reports, technical documentation of medical devices, genotoxicity assessments.
This scientific community has been an invaluable help in my work and I am very glad to be a part of it.
Hi everyone,
My name is Ken Meade. I’m a Compliance Specialist at Contract Pharmaceuticals Ltd. (CPL) in Canada. My company is a contract manufacturer of liquid and semi-solid drug products.
Preparation of nitrosamines risk assessments has been assigned to me. I have already learned a lot about nitrosamines through this forum, and I hope to continue getting great advice from the many experts here.
Good morning Mr. Naiffer,
Thank you for accepting my request. I’m very happy and excited to be a part of this group. I Dr. Divakara LS Nori, working as R&D Scientist in pharmazell India private Limited, an axplora company. My role is process development of APIs by evaluation of GTI and Nitrosamines. I have 21 years of experience in the field of R&D, Discovery and CDMO. I have been nominated to focus more on the topic of Nitrosamines, NDSRI’s by Management and I’m looking forward to gaining some good knowledge from all the experts of this group. Thank you once again. With Best Regards
My name is Geoffrey Yeh, and I actually joined back in March 2022, but lost account access by imprudently using a company email rather than a personal one. Anyway, it’s great to be back to be onboard with this group; it’s a fantastic resource. With the new CDER guidance, I’m eager to digest people’s interpretations and the wealth of knowledge here. Thanks!
Dear collegues: my name is Claudia Ortiz-Nava and I am working as a Research Senior Chemist in a Pharmochemical Industry in Mexico . Currently, I am working on the risk analysis assesment of N-nitrosamines. I am joined this community with great excitment to learn more from you because I am a beginner in this subject, thaks to all!
I am Dr. Güler Yağmur Akyüz, and I completed my Ph.D. in Pharmaceutical Toxicology in Turkey. My research focuses on the investigation of nitrosamine impurities in metformin-containing drug products, a widely used treatment for Type 2 diabetes. My dissertation, titled “Determination of Nitrosamine Impurities and Evaluation of Mutagenicity Potential in Metformin-Containing Drug Products in the Turkish Market,” aims to address global concerns about the presence of N-Nitrosodimethylamine (NDMA) impurities in pharmaceuticals.
As part of this study, I utilized liquid chromatography tandem mass spectrometry (LC-MS/MS) to analyze metformin products from different manufacturers.
I look forward to contributing further to the field and engaging with colleagues who are working on similar issues surrounding pharmaceutical safety and impurity analysis.
My name is Beena Mahida. Am a pharmacist by qualification and working as Regulatory Affairs Manager at Cosmos Ltd, which is one of the largest Local Pharmaceutical Manufacturing Company in Kenya and East Africa.
Am happy to be part of this community and i look forward to learning from all here.
Thank you.
Hello All
This is Dr Gopal Venkat, Lab Director at Scientech Labs LLC. we have been working on nitrosamine risk assessment and related method development. Nice to be part of this group and looking forward to useful interaction with you all
Hello, my name is Diullio. PhD in theoretical chemistry and data scientist.
I currently work with nitrosamines and automation in the pharmaceutical industry. I develop AIs to automate routines and laboratories, such as automating nitrosamine reports, in silico degradation, and AI for legislation.
Anyway, it’s great to be back to be onboard with this group; it’s a fantastic resource. With the new CDER guidance, I’m eager to digest people’s interpretations and the wealth of knowledge here. Thanks!
. Currently, I am working on the risk analysis assesment of N-nitrosamines. I am joined this community with great excitment to learn more from you because I am a beginner in this subject, thaks to all!