Analytics

EDQM outlines the steps it will take to implement the ICH Q3D guideline on elemental impurities.

B&W Tek’s director of Market and Customer Development, Katherine A. Bakeev, PhD, discusses analysis of pharmaceutical raw materials and the benefits of using handheld Raman spectrometers.

The European Pharmacopoeia Commission adopted a chapter on chemical imaging for analytical development, quality control, and manufacturing.

Analytical technologies play a key role in the characterization and quantitation of oligonucleotide therapeutics.

The authors present a set of statistical decision rules based on linear regression models that can be implemented in an automated trend system to assist stability studies.

Isothermal titration calorimetry and differential scanning calorimetry are valuable tools that can help accelerate drug development.

The integration of a method validation, transfer, and verification process into the overall lifecycle management process of a product can best align the variability of the analytical procedure with the requirements of the product.

Understanding of endotoxin assays and a range of detection technologies are essential for effective testing.

The Uniformity of Dosage Units test is used to evaluate content uniformity or weight variation or dosage forms such as tablets and capsules. The author introduces two different acceptance value limits (n = 10 and 30) in this article.

Agilent’s new facility in Folsom, California includes laboratory, order fulfilment, and warehousing space.

New software platforms aim to help manufacturers implement connected technology and use data efficiently.

The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.

Dedicated facility will address enhanced regulation of metals and impurities in pharmaceuticals.

Idifarma has announced a growth of more than 50% over the past two years. Revenue is expected to hit approximately EUR5.3 million in 2016, growing from EUR3.5 million in 2014.

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.

A dissolution method should have adequate discriminatory power to detect formulation changes that affect the dissolution rate of a drug product.

The new guidelines will address bioanalytical method validation and biopharmaceutics classification system-based biowaivers.

Recipharm announced that it has invested 5 million SEK in a new GLP bioanalysis laboratory in Uppsala.

The CPhI Pharma Award for Excellence in Analysis, Testing, and Quality Control went to B&W Tek for its handheld laser induced breakdown spectroscopy (LIBS) analyzer, NanoLIBS, which has been developed for rapid identification of solid materials based on elemental analysis. The instrument features a raster scan using a high repetition rate class 3B laser allowing for detection of elements including C, Li, and Be.

The next decade of drug development will depend on better ways of storing, using, and analyzing data, says CPhI advisor Bikash Chatterjee, president and chief science officer of Pharmatech Associates. But each of the following must be optimized: volume, variety, velocity, veracity, and value.

The agency published a guideline for the implementation of ICH Q3D.

Visual inspection of parenteral vials is the first step in a root cause investigation.

The Chinese facility was cited for data integrity violations.

New technology introduced in 2016 aids innovation growth for pharmaceutical manufacturing.

This paper describes a unique Prep-rP-HPLC technique that uses a C-18/C-8 derivatized silica coated with a hydrophobic quaternary ammonium salt or quaternary phosphonium salt that acts as an additional/surrogate stationary phase (AsP/ssP).

Conventional limit-setting techniques are not health-based and can make risk assessment more difficult.

Stability testing programs should provide drug owners the information needed to establish the proper handling, shipping, and shelf-life recommendations for drug products.