Analytics

Editor of Pharmaceutical Technology Europe

Articles

Common approaches to analyze elemental impurities for compliance with regulatory requirements are robust but still have some limitations.

Approaching Elemental Impurity Analysis

Agnes Shanley is senior editor of Pharmaceutical Technology.

Carcinogenic compounds have been found in a number of top-selling drugs, leading to recalls and bans. Preventing problems requires working closely with contract testing and development partners as well as API and other suppliers.

Collaborating to Prevent Genotoxic Contamination

Cynthia A. Challener is a contributing editor to Pharmaceutical Technology.

The correct mix of excipients is crucial to the success of fast dissolving/orally disintegrating dosage forms.

Formulating for Convenience and Compliance

With new tests showing NDMA levels increase under normal storage conditions, FDA calls for removal of ranitidine products from the market.

FDA Removes Ranitidine Products from Market

Analytical solutions are improving for raw material testing, drug product release process development, and more.

Biopharma Analysis Benefits from New Technology and Methods

The Raised Stopper Inspection machine from Antares Vision verifies proper sealing of freeze-dried vials.

Machine Inspects Lyo Seals

Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.

Can Bioprocessing Achieve Digital Transformation?

Leachable silicone oil may have an effect on large-molecule APIs, making it important to establish a robust analytical method to detect and quantify the substance.

A Study of Leachable Silicone Oil in Simulated Biopharmaceutical Formulations

Anderson Albuquerque is pharma tech lab expert at the Global Pharma Tech Laboratory, Merck SA, Rio de Janeiro, Brazil.

Raphael Lopes is pharma tech lab expert, all at the Global Pharma Tech Laboratory, Merck SA, Rio de Janeiro, Brazil.

Renato BP Pinto is head of the Global Pharma Tech Lab at the Global Pharma Tech Laboratory, Merck SA, Rio de Janeiro, Brazil.

Particle morphology of magnesium stearate, added as an anti-caking agent in a high water‑soluble drug substance, has an influence on the dissolution rate of compressed tablets.


Role of Particle Morphology on Tablet Dissolution Rates

Gayatri C.Patel, M.Pharm, PhD, is associate professor in the Department of Pharmaceutics & Pharmaceutical Technology, Ramanbhai Patel College of Pharmacy at the Charotar University of Science and Technology, Changa Campus, Changa- 388 421, Anand, Gujarat, India, gayatripatel.ph@charusat.ac.in, +91 2697 265162.

Chintan Patel is a researcher in the Department of Biotechnology, Zydus Research Centre, Cadila Healthcare Ltd., Ahmedabad, Gujarat, India. 

Sanjay Bandyopadhyay, PhD, is vice-president in the Department of Biotechnology, Zydus Research Centre, Cadila Healthcare Ltd., Ahmedabad, Gujarat, India

It is important to address manufacturing problems associated with the shorter shelf-life of pegylated L-asparaginase (pegaspargase) upon long-term storage in the form of a solution. 

Finished Product Analysis