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Dissolution Testing

Nasal spray - under recall

Nasal spray - under recall

UK MHRA announces two Class 2 medicine recalls

23 July 2020 | By Victoria Rees (European Pharmaceutical Review)

A batch of Nitrofurantoin and all unexpired stock of Desmopressin nasal spray are being recalled in the UK, the MHRA has announced.

hand lifting yellow and white capsule from a sectioned drug box with other capsules of different colours in it

hand lifting yellow and white capsule from a sectioned drug box with other capsules of different colours in it

Avet recalls tetracycline HCl capsules to consumer level

22 April 2020 | By Hannah Balfour (European Pharmaceutical Review)

The company announced the voluntary recall is due to low, out of specification dissolution test results in specific batches of its tetracycline products.

Various medicines

Various medicines

MHRA announces two medicine recalls

20 February 2020 | By Victoria Rees (European Pharmaceutical Review)

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.

Pharma - Blue pills with connected lights

Pharma - Blue pills with connected lights

In silico techniques – a JPAG event

18 February 2020 | By Victoria Rees (European Pharmaceutical Review)

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 biowaivers

18 December 2019 | By Dave Elder (JPAG Member and David P Elder Consultancy)

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…

Clinically relevant dissolution specifications: selection and assessment

9 January 2019 | By Chun-Hang Tang, Juliet Symonds, Kevin Lief

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.

AdvantaPure® completes full BPOG extractables testing of several silicone and TPE tubing products

22 June 2018 | By AdvantaPure

Provides Drug Manufacturers with Extensive Test Results for Tubing Comparison...

Dissolution testing in the modern world

Dissolution testing in the modern world

Dissolution testing in the modern world

29 February 2016 | By David Elder (JPAG member and consultant), Juliet Symonds

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…

Sirius Analytical product launch: surface dissolution imaging for real-time visualization of dissolution phenomena

10 January 2013 | By Sirius Analytical Instruments Ltd

Sirius Analytical Instruments Ltd announces the introduction of a new product...

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