news
MHRA announces recall of Zantac products made by GSK
The UK MHRA has issued an alert for the recall of unexpired Zantac products made by GSK due to the possible contamination of ranitidine in the medicines.
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Impurities
news
FDA recommends LC-HRMS to test for NDMA in ranitidine products
The FDA recommends drug manufacturers to use LC-HRMS to test for NDMA in ranitidine products, as high temperatures generate the impurity.
news
EMA releases guidance to companies on avoiding nitrosamines in drugs
The European Medicines Agency has issued advice to pharmaceutical companies on how to avoid the presence of nitrosamines in medicines.
news
Sandoz voluntarily recalls ranitidine over NDMA contamination concerns
The probable carcinogen N-nitrosodimethylamine was detected in Sandoz’s ranitidine capsules, prompting the voluntary move.
news
Losartan drug recall expanded to include five more lots
FDA announces the voluntary recall for the losartan medications has been extended to include more lots, after impurities were found in the drugs.
news
EMA to provide guidance on avoiding nitrosamines in medicines
The EMA has announced it is drafting guidance on how to avoid the presence of nitrosamines, a probable carcinogenic ingredient, in drugs.
news
NDMA discovered in samples of ranitidine medicines
The EMA and the FDA are investigating some ranitidine medicines after they were found to contain NDMA, a probable human carcinogen.
article
How tablet formulation can impact production
Transforming a formulation into a successful solid dose product is a complex process that involves many considerations. Given the ever-growing demand for increased tablet quantities and the goal of reducing time to market, Rob Blanchard explains how the pressure is on manufacturers to find innovative processes to improve production efficiency.
news
FDA announces expansion of generic impurity investigation
The examination of ARB drugs by the FDA will be extended to include other generics with similar manufacturing processes to identify impurities.
news
17 Spanish infants develop ‘werewolf syndrome’ after drug mislabelling
Young children in Spain have developed hypertrichosis, also known as ‘werewolf syndrome’, after a reflux drug was contaminated with an alopecia treatment.
news
Macleods Pharmaceuticals issues recall due to NMBA impurities
Macleods has issued a recall of 32 lots of drug products that contained trace amounts of NMBA impurities.
whitepaper
Article: Tips & tricks: sensitivity gains in LC-MS
The prerequisite of any highly sensitive analysis via HPLC-MS (high performance liquid chromatography coupled to mass spectrometry) is the use of ultrapure solvents and reagents and careful handling of all associated materials, consumables, and systems.
article
Assessing host cell protein contamination in biotechnological products
Purification of a drug from host cell protein contaminants can be challenging, with low-level contamination often remaining after purification. Vanda Dolabela de Magalhães shares discussions on the subject from six Brazilian companies working in the biotech field.
whitepaper
Whitepaper: Supelco preparative HPLC products for pharmaceutical development and production
There is an increasing need for purified materials in the development and production of pharmaceutical products. FDA and other regulatory agencies continue to require more stringent purity requirements on active pharmaceutical ingredients (API), including most recently chiral purity.
whitepaper
Whitepaper: USP 643: the wrong end of the stick
To ensure that USP/EP standards are met, TOC of highly purified water can be determined by internal purification-process monitoring.
