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Application Note: Stearates verification using a handheld Raman analyzer
In this application, a Principal Component Analysis (PCA) method was found to be successful in identifying the various stearates...
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Manufacturing
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Application note: Representative sampling in process Raman spectroscopy
Raman spectroscopy is an analysis technique that provides a “molecular fingerprint” of the sample, enabling analysis of chemical composition and molecular structure without sample preparation..
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Whitepaper: Meeting modern data integrity and compliance requirements
FDA was perhaps understating a point when it said in its April 2016 Draft Guidance: Data Integrity and Compliance with cGMP that the increasing number of data integrity-related cGMP violations identified during its inspections was ‘troubling’...
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ROMIL Hi-Dry® – anhydrous solvents you can depend on
ROMIL’s Hi-Dry® anhydrous solvents take the high purity concept of ROMIL-SpS™ Super Purity Solvents one step further...
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Whitepaper: Extractables and leachables testing – A risk based approach
Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient...
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Whitepaper: Data Integrity: Technical controls that demonstrate trust
Using Chromeleon 7 Chromatography Data System for enhanced data integrity...
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FUJIFILM Diosynth Biotechnologies testing services
Technical leadership in contract development and manufacturing...
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Quotient Sciences launches as the new global identity for Quotient Clinical
Quotient Clinical, the drug development services organisation, announces its renaming to Quotient Sciences (Quotient), following the acquisitions of Co-Formulate, QS Pharma and SeaView Research...
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Modernising the supply chain using continuous manufacturing
When the United States Food and Drug Administration (FDA) called for a shakeup of pharmaceutical production in 2002 it recommended the early adoption of technological advances and the application of modern quality management techniques. It believed that this would make manufacturing processes more robust and improve product quality.1
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ProCellics™ – first in-line and real-time bioprocess raman analyser
ProCellics™, first in-line and real-time bioprocess raman analyser, is a RESOLUTION Spectra Systems product. It offers a GMP user-friendly and easily deployed Process Analytical Technology (PAT) solution...
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Whitepaper: Nitrosamines: analysis for extractables and leachables
This selective detection method greatly improves the prospect of detecting nitrosamines in pharmaceutical products and medical devices that incorporate rubber or latex...
