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Category Archives: Impurity profile

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

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

Unique API Particle Size Projects On the Rise

Why is there a growing preoccupation with particle size? It’s because particle size can alter the efficacy (e.g., bioavailability) and safety profile (e.g., toxicity) of a compound. Complex particle sizing…

Posted in APIs, Chemistry, CMC, drugs, Impurity profile, micronization, Neuland Labs, particle size, process chemistry, Process Engineering, QbD | Comments Off on Unique API Particle Size Projects On the Rise

Inside Sugammadex: Overcoming Impurities in Commercial API Manufacturing

The first in the class of drugs known as selective relaxant binding agents (SRBA), Sugammadex sodium is used to reverse anesthesia. Via 1:1 binding of rocuronium or vecuronium, it rapidly…

Posted in Chemistry, CMC, Contract Manufacturing, generic, Impurity profile, process chemistry, Process Engineering, Route Design, Synthesis Route | Tagged , | Comments Off on Inside Sugammadex: Overcoming Impurities in Commercial API Manufacturing

QbD and Evaluating ‘What-If’ Drug Manufacturing Scenarios

In recent posts on the topic of Quality by Design and drug manufacturing, we referenced (here, here and here) the importance of being able to reduce unanticipated challenges by developing…

Posted in API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, CQA, critical reaction parameters, Design of Experiment, FDA, Impurity profile, Neuland Labs, process chemistry, QbD, Quality | Comments Off on QbD and Evaluating ‘What-If’ Drug Manufacturing Scenarios

Emerging Trends in Analytical R&D

In the pharmaceutical discovery space, many promising analytical trends have emerged and are now on the rise – and they will see increasing use in drug discovery in coming years….

Posted in analytical science, APIs, Capabilities, Chemistry, chromatography, drug discovery, HPLC, Impurity profile, method development, process chemistry, QA/QC, Quality, R&D, RP-HPLC | Comments Off on Emerging Trends in Analytical R&D

Green Chemistry and Benign by Design

7 ways to boost profits and reduce pharma synthesis waste At Neuland, we’re advocates of green chemistry. Not only is it better for the environment, but it’s also just logistically…

Posted in analytical science, API synthesis, APIs, atom economy, Benign-by-Design, Capabilities, Chemistry, CMC, Contract Manufacturing, EHS, energy conservation, energy effciency, green chemistry, ICH, Impurity profile, Quality, R&D, Route Design, Route Scouting, small molecule, synthesis, Synthesis Route, Uncategorized, zero liquid discharge | Comments Off on Green Chemistry and Benign by Design

Quality Control & Assurance Are Constantly Evolving

Sometimes I feel like I come across as a bit too “QA crazy,” but quality in the pharma sense isn’t really something of which you can have too much. From…

Posted in Contract Manufacturing, FDA, Impurity profile, Neuland Labs, QA/QC, Quality | Comments Off on Quality Control & Assurance Are Constantly Evolving

API Production: Building an Impurity Profile

Impurities and the ICH Limits for Impurities Impurities are unwanted chemicals produced during normal manufacturing of Active Pharmaceutical Ingredients, or APIs. As you well know, impurities have no therapeutic value…

Posted in analytical science, API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, CRO/CMO, ICH, Impurity profile, method development, Quality, regulatory | Comments Off on API Production: Building an Impurity Profile