UK MHRA announces two Class 2 medicine recalls
A batch of Nitrofurantoin and all unexpired stock of Desmopressin nasal spray are being recalled in the UK, the MHRA has announced.
List view / Grid view
A batch of Nitrofurantoin and all unexpired stock of Desmopressin nasal spray are being recalled in the UK, the MHRA has announced.
The company announced the voluntary recall is due to low, out of specification dissolution test results in specific batches of its tetracycline products.
The Medicines and Healthcare products Regulatory Agency has issed two alerts for medicine recalls in the UK due to out of specification dissolution results and an error in decommissioning.
European Pharmaceutical Review attended a JPAG event, exploring the plethora of uses for in silico techniques in the pharmaceutical industry.
ICH M9 biopharmaceutics classification system-based biowaivers1 is currently at step 2b and feedback from interested parties is being evaluated.2 This guideline should reach the implementation stage (step 4) during 2020. However, industry still has concerns relating to several key areas of the guidance. Here, Dave Elder summarises these ICH M9…
Setting specifications for new oral products can be challenging. Too lenient, and there is a risk of passing batches of inadequate quality; too stringent, and there is a risk of rejecting acceptable batches.
Provides Drug Manufacturers with Extensive Test Results for Tubing Comparison...
Historically, dissolution testing has been used primarily as a quality control (QC) test for solid oral drug products1. Indeed, it is the only QC test which provides a measure of the quantitative release rate of the drug from the pharmaceutical product. More recently, the test has been proposed in lieu…
10 January 2013 | By Sirius Analytical Instruments Ltd
Sirius Analytical Instruments Ltd announces the introduction of a new product...