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Raman: In-Depth Focus 2016
In this Raman In-Depth Focus: Raman as a valuable tool in high-throughput screening; Use of Raman in analysing polymorphism in pharmaceutical drugs; Upcoming Raman calibration standards; Raman roundtable...
List view / Grid view
QA/QC
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Dissolution testing in the modern world
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…
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Expert View: Standardisation through automation
29 February 2016 | By SOTAX Group
There are several sources of variability in the “inherently poor design” of compendial dissolution apparatus types. Nevertheless, dissolution testing is a QC requirement for many products, and so the industry faces the challenge of implementing and managing fleets of dissolution equipment. However, through instrument and process design and automation, managing…
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The challenges of riskbased environmental monitoring in sterile product filling
Completing risk assessments is an inherent part of good manufacturing practice (GMP) and risk-based environmental control and monitoring (EM) in sterile product filling within isolators and restricted access barrier systems (RABS). This article considers the challenges the pharmaceutical industry faces in characterising conventional risk assessments like failure modes and effects…
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Upcoming Raman calibration standards
In this article, Kerstin Barr, Product Manager for handheld Raman instruments at Thermo Fisher Scientific, comments on the revised tolerances...
whitepaper
Whitepaper: Is it essential to sequence the entire 16S rRNA gene for bacterial identification?
The biopharmaceutical industry, especially manufacturing facilities, needs to implement bacterial identification to avoid the occurrence of a problematic microorganism in the final product that could be harmful for the end user and detrimental to a company’s finances and reputation.
news
Presentation videos from the World’s 1st International Pharmaceutical seminar on Transmission Raman Spectroscopy available online
27 January 2016 | By Colbalt Light System
Videos of the presentations from the world’s 1st TRS seminar for quantitative pharmaceutical analysis can be viewed on demand...
whitepaper
Application Note: In-line Raman spectroscopy for content uniformity
Raman monitoring of blended granule uniformity prior to tablet press...
whitepaper
Application Note: MicroNIR PAT for blend monitoring
The aim of Quality by Design (QbD) is to build quality into a product and process from the outset. The pharmaceutical and related industries utilise powder blending operations to make solid dose drugs, yet the phenomena of powder mixing is the least understood of all sciences.
whitepaper
Application Note: Are you seeing the whole picture with Raman?
Raman spectroscopy offers a rapid, convenient method for positive identification of pharmaceutical products and their raw materials – on the manufacturing floor, in inventory, and at the shipping dock.
whitepaper
Application note: Clean room dehumidification ensures reliable test results
Scandinavian Micro Biodevices (SMB), in Denmark, develops, produces and markets ‘point-of-care’ diagnostic systems for the veterinary market. In order to maintain a very low level of humidity in the clean room, a desiccant dehumidifier is required.
whitepaper
Application Note: Morphological changes in drug compounds under the microscope
Heated crystalline pharmaceutical compounds undergo morphological changes that can be observed under a microscope. With hot-stage microscopy changes in melting points and ranges or crystallisation can be visualised for research and QC purposes in order to influence drug stability or effectiveness...
whitepaper
Application Note: Raman spectroscopy of pharmaceutical ingredients under humidity controlled atmosphere
Monitoring the stability of the API under high humidity is critical to verify that the polymorphic active form remains intact. Being very chemically selective to subtle changes such as polymorphic forms, Raman spectroscopy is used to monitor and understand the stability of ingredients...
news
Rapidly develop drugs targeting Interleukins with new PathHunter® cell-based assays from DiscoveRx
DiscoveRx Corporation, the leading supplier of innovative cell-based assays and services for drug discovery and development, announces the expansion of its PathHunter® cell-based assays portfolio with the release of PathHunter Interleukin cell-based assays.
news
X2 series balances innovative functional solutions
7 January 2016 | By RADWAG
The X2 series embodies synergy between conventional solutions characteristic for high quality balances, and technology intended mainly for professional standards...
