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Category Archives: genotoxic impurities

Nitrosamines – A Timeline

Here’s an infographic detailing some of the history of nitroso compound contaminants. Nitrosamine, a probable human carcinogen, continues to make the news as the FDA, EMA and other regulatory agencies…

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The Impact of Impurities on the Pharmaceutical Industry

A significant paradigm shift is underway in the regulatory environment for impurities in pharmaceutical products. Recent incidents involving genotoxic impurities (GTIs) are driving tighter restrictions and guidelines, as well as…

Posted in API synthesis, APIs, Chemistry, drugs, genotoxic impurities, Impurity profile, QA/QC, Quality, Route Design, Route Scouting, synthesis, Synthesis Route, Valsartan | Comments Off on The Impact of Impurities on the Pharmaceutical Industry

Nitrosamine Impurities and How Companies are Addressing the Crisis

We’ve recently written extensively about nitrosamine impurities, including this in-depth analysis of what transpired with Valsartan, and some follow-up material, here and here. Nitrosamine impurities have been receiving a great…

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Valsartan Contamination: A Follow-Up

Following up on our earlier post on the 2018 valsartan contamination, much has happened over the last six months. In our original post, we discussed the appearance of impurities in…

Posted in APIs, CMC, drugs, FDA, genotoxic impurities, Impurity profile, process chemistry, QA/QC, regulatory | Tagged , , , , , , | Comments Off on Valsartan Contamination: A Follow-Up

6 Pharma API Regulatory Challenges to Watch

A couple of years ago, I published a post on 5 API Regulatory Challenges to Avoid, and it was interesting to look over the list and contemplate what updates I’d…

Posted in API synthesis, APIs, Big Data, FDA, genotoxic impurities, green chemistry, method development, Quality, regulatory, Route Design, Route Scouting, synthesis, Synthesis Route | Comments Off on 6 Pharma API Regulatory Challenges to Watch

Genotoxic Impurities – Increasing Vigilance, But Still Some Uncertainty

A genotoxic impurity (GTI) is a chemical substance that can directly or indirectly damage DNA or chromosomes and induce genetic mutations. Fifteen years ago, there were no specific guidelines for…

Posted in analytical science, API synthesis, APIs, Chemistry, CMC, critical reaction parameters, genotoxic impurities, QA/QC, Route Scouting, Uncategorized | Comments Off on Genotoxic Impurities – Increasing Vigilance, But Still Some Uncertainty

APIs See Continuous Improvement…but Only Until Clinical Trials

In what can best be described as a quality paradox, continuous process improvement has become something of a buzzword in the pharma manufacturing industry. But, as Epcot President & CPhI…

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Peptide Process Chemistry – A New Era?

Since pioneers such as Bodanszky and Du Vigneaud first produced them synthetically in the 1950’s, peptides have always held tremendous – but unrealized – promise for human health. Despite their…

Posted in APIs, Capabilities, cardiovascular disease, Contract Manufacturing, drug delivery, genotoxic impurities, Neuland Labs, oncology, peptide, peptides, R&D, scale-up, transdermal | Comments Off on Peptide Process Chemistry – A New Era?

Are Current Genotoxic Impurity (GTI) Regulations Too Weak?

Genotoxic impurities were around long before humans first began boiling bark.  Our attempts to quantify, understand and control GTI formation, however, is a much more recent phenomena. It’s also a…

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You Can’t Keep a Good Drug Down

Reducing Mutagens, Carcinogens & Other Genotoxins to Improve Safety Profiles There are a number of process modifications API manufacturers can make to improve safety profiles, reduce production costs, improve capacity…

Posted in analytical science, APIs, Capabilities, Chemistry, CMC, Contract Manufacturing, critical reaction parameters, CRO/CMO, drugs, EHS, genotoxic impurities, green chemistry, method development, Neuland Labs, QA/QC, QbD, R&D, regulatory, Route Design, scale-up, Synthesis Route, zero liquid discharge | Comments Off on You Can’t Keep a Good Drug Down