Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
News|Articles|June 2, 2016
PTSM: Pharmaceutical Technology Sourcing and Management
- PTSM: Pharmaceutical Technology Sourcing and Management-06-07-2016
- Volume 11
- Issue 6
Analyzer Complies with New Raman Calibration Standards
Rigaku Analytical Devices’ Progeny 1064nm handheld Raman analyzer is compliant with the new calibration standards published by the European Pharmacopeia .
The demand for rapid identification of raw materials has led to improvements in handheld Raman instruments.
Rigaku Analytical Devices’ Progeny 1064nm handheld Raman analyzer is compliant with the new calibration standards published by the European Pharmacopeia (EP) in Supplement 8.7, Chapter 2.2.48 in October 2015 and effective April 1, 2016.
New regulations set acceptable Raman wavelength shifts and associated tolerances for benchtop and handheld Raman instruments for pharmaceutical applications.
The device overcomes sample-induced fluorescence interference through the use of a 1064nm excitation laser, which also enables measurements to be taken through packaging. The device facilitates regulatory compliance by providing a IQ/OQ/PQ protocol package, compliant 21 CFR Part 11 digital signatures and an integrated camera for barcode reading to ensure error-free data entry.
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Articles in this issue
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Slow Serialization Efforts May Delay Business Benefitsover 10 years ago
Scientific Approach Ensures Accurate Weighing Resultsover 10 years ago
Ensuring Biologic API Uniformityover 10 years ago
Biomanufacturing Outsourcing Budgets Grow, Slowlyover 10 years ago
Novasep Starts Kilogram-Scale Batch Production at US Facilityover 10 years ago
FUJIFILM Opens New Laboratory in North Carolinaover 10 years ago
Catalent Opens Korean Sales Officeover 10 years ago
Juniper Pharma Services Expands Topicals Capacityover 10 years ago
ED-XRF Spectrometers Offer Rapid Elemental Analysisover 10 years ago
Raman Microscope Measures Uneven SurfacesRelated to this article
This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
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Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.
Jason Bertola, executive director of Commercial Development for the Advanced Synthesis Platform at Lonza in North America, explains the demand for spray drying and the hurdles involved with scale up, in an interview with PharmTech.
Ron Scarboro, Azurity Pharmaceuticals, explains when formulation robustness justifies added cost and which post-approval quality and supply metrics teams can track.
The winners of the CPHI Pharma Awards 2026 include a neurodegeneration platform, a track-and-trace packaging innovation, a enzymatic mRNA manufacturing technology, and a cell-free enzymatic biomanufacturing platform.