Impurity deficiencies in submissions are remarkably consistent. Subathra Ramamoorthy, Veranova, explains how to catch them before agency filing.
News|Articles|July 2, 2017
- Pharmaceutical Technology-07-02-2017
- Volume 41
- Issue 7
Dissolution Tester Eliminates Water Bath
A bathless dissolution tester from Distek operates without a water bath and associated maintenance.
The
eliminates the water bath and all associated maintenance while heater jackets raise media temperature from ambient to 37 °C in less than 15 minutes. Wireless in-shaft temperature sensors continuously monitor and display the in-vessel temperature for each vessel. The dissolution tester includes a touch screen, electronic tracking of serialized stirring elements, qualification status and due dates, and reporting and method storage capabilities.
Articles in this issue
over 9 years ago
Packaging Improves Medication Adherenceover 9 years ago
The New World of Biopharmaceutical Manufacturingover 9 years ago
Forty Years of Drug Product Manufacturing Advancesover 9 years ago
Advances in Analytical Testing Tools for the Bio/Pharma Industryover 9 years ago
Ribbon Blenders for Specialty Applicationsover 9 years ago
Coating Module Supports Easy Module Exchangeover 9 years ago
Bioreactor Family Includes Single-Use Bagsover 9 years ago
FDA Continues to Promote Quality Drug ProductionRelated to this article
Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.
Subathra Ramamoorthy, Veranova, on when to escalate to structural elucidation and pair orthogonal techniques when characterizing an impurity.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF, talks about spray drying for drying amorphous solid dispersions and Raman spectroscopy’s role as a quantitative analytical tool.
Nitin Kumar Swarnakar, PhD, global application lab manager at BASF in Tarrytown, spoke with PharmTech at AAPS PharmSci 360 about formulation and characterization challenges for amorphous solid dispersions.
FDA draft guidance on individualized genome editing lets BLAs add patient-specific variants without new trials, shifting evidence to CMC assay data.
Vibha Jawa, PhD, chief scientific officer at EpiVax, explains why the need for animal studies varies by modality and what it takes for organ-on-chip and other human-relevant models to replace these studies in IND-enabling toxicology work.
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