After nitrosamines were detected in sartan medicines, the EMA has released new recommendations about handling and reporting impurities in drugs.
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A simple, sensitive and selective direct method using IC coupled to a single quadrupole MS to analyse organic acids in drug solutions.
Alina Dvoretskaya describes how 3D technologies are used in pharmacology and the benefits these offer to the healthcare industry.
Smita Deshmukh describes the current state of the global drug intermediates market, while suggesting how it will grow in the future.
All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Rapid sterility testing, which offers an incubation period of five days or less, provides a solution.
Whitepaper: Establishing the proper alcohol/water proportion for simulating solvents used in controlled extraction studies
This paper provides scientific guidance as well as a case study on the effect of solvent polarity (ethanol/water proportion) on the levels of extractables.
Stability testing is a vital part of product development and is conducted throughout a product’s life cycle.
Solid dosage forms have been one of the foremost choices of drug administration for generations. However, with an ever-growing global population, evolving customer demands and continual updates to regulations comes greater need for advanced medicines and progress in this sector. This article explores the benefits and how the field must…
The FDA has said that Amneal Pharmaceuticals is recalling three lots of nizatidine oral solution at the consumer level due to potential NDMA contamination.
The FDA has handed a warning letter to an Indian manufacturing facility for inadequate sterility testing and environmental monitoring.
The US Food and Drug Administration (FDA) issued the letter after finding the products contain chlorine dioxide, a powerful bleaching agent with potentially fatal side effects.
Experiments testing the artificial cardiac patch in pigs and rats showed the patch can reduce scarring and improve cardiac function after a heart attack.
Liquid chromatography is an analytical technique utilised widely in the pharmaceutical industry. How does it work and what other methods can it be combined with to enhance its uses?
The US FDA has announced that all manufacturers should withdraw their ranitidine products from the market due to the risks associated with NDMA impurities.