Analytical Instrumentation

Fluence Analytics’ Argen is a protein and polymer stability monitoring product that uses continuous light scattering measurements to produce an information stream.

Clariant’s Tri-Sorb Desiccant Tablets are designed for USP moisture testing of blister packs.

An updated version of Shimadzu’s LabSolutions analytical data system incorporates additional functions to comply with data integrity regulations, and to support development and quality inspection procedures.

New algorithm and functions in Shimadzu’s LabSolutions software enable compliance with data integrity regulations.

The Nano-flow imaging particle analyzer from Fluid Imaging Technologies automatically image nanoparticles for identification.

This study shows that the presence of API lumps can be detected by inline NIR, and elaborates on why NIR sensor dimensions and actual measured sample volume by the NIR sensor are important variables for adequate interpretation of obtained results.

Industry experts discuss how advances in analytical testing tools have helped address challenges in pharmaceutical analysis.

A bathless dissolution tester from Distek operates without a water bath and associated maintenance.

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.

Industry experts discuss best practices for dissolution testing of poorly soluble, immediate-release, and controlled-release formulations and the different analytical approaches used.

Endress+Hauser’s Memosens CPS171D pH electrode for hygienic and sterile biopharmaceutical processing provides stable measurements even after multiple cleaning and sterilization cycles.

MDRS differentiates the API from the product matrix and enables measurement of particle size and shape.

RSSL has added new equipment for measuring the surface area of powder particles, which is important for determining the performance of excipients and APIs.

The innovations-oriented Think Tank combines academic-scientific and technical expertise to use Shimadzu’s expertise to provide even more customer-focused service.

Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall lab efficiency.

The companies have developed a Level 4 traceability solution to manage pharmaceutical regulatory requirements.

SGS expands its elemental impurity testing services at its laboratory in Villeneuve-la-Garenne, France.

Improved process analytical technology and new ways of thinking seek to enhance measurement and control for next-generation pharmaceutical manufacturing.

Modular Automated Sampling Technology (MAST) allows direct aseptic transfer of bioreactor samples to analytical devices, providing rapid and reliable data in bioprocessing.

Although limitations must be overcome, mass spectrometry is having a great impact on biologic development and manufacturing.

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.

The authors survey deficiency letters issued for 190 drug master files supporting abbreviated new drug application submissions.

This article introduces the concepts of pooled variance and the central limit theorem, which are intended for establishing acceptance criteria for blend uniformity data of granular powder blends when a significant degree of sampling bias is involved.

The RA802 Pharmaceutical Analyzer from Renishaw is a compact benchtop Raman imaging system that enables users to formulate tablets by speeding up the analysis of tablet composition and structure.

Analytical products for improved bio/pharmaceutical development.

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 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.