Impurity deficiencies in submissions are remarkably consistent. Subathra Ramamoorthy, Veranova, explains how to catch them before agency filing.
News|Articles|December 2, 2017
- Pharmaceutical Technology-12-02-2017
- Volume 41
- Issue 12
Oven Autosampler for Automated KF Titration
The InMotion Karl Fischer (KF) Oven Autosampler from Mettler Toledo is suited for KF titration and comes in two models, InMotion Flex and InMotion Pro, and allows up to 26 samples to be analyzed on a 25-centimeter platform.
The InMotion Karl Fischer (KF) Oven Autosampler from Mettler Toledo is suited for KF titration and comes in two models: InMotion Flex and InMotion Pro. Features include a vial with a one-piece screw cap for sample preparation safety, an automatic gas flow meter for gas flow control, and a temperature scan function that can determine a substance’s ideal heating temperature in one run containing up to 120 samples without stopping, according to the company.
The instrument allows up to 26 samples to be analyzed on a 25-centimeter platform. The Pro model offers three platforms and vial size, with customizable sizes available. The procedure calibrates both the oven temperature and the gas flow rate to the titration cell, complying with current Official Medicines Control Laboratory (OMCL) guidelines (Qualification of Automatic Titrators, 2016). Details are documented with certificates, and the company provides service and support throughout the product’s entire lifecycle. Additionally, both models connect to the latest versions of the company’s Volumetric (V30S) and Coulometric (C30S) KF Titrators, as well as to the modular T7 and T9 Excellence Titrators.
Articles in this issue
almost 9 years ago
Disputes Over Manufacturing Waiver and Other SPC Exemptionsalmost 9 years ago
Opportunities with Softgelsalmost 9 years ago
What’s in Your SOP?almost 9 years ago
Transformative Medicines Challenge FDA and Manufacturersalmost 9 years ago
Pharma Outsourcing: A Year in Reviewalmost 9 years ago
Outsourcing: A Year in Reviewalmost 9 years ago
Designing Sustainable Pharma Facilitiesalmost 9 years ago
Evaluating Surface Cleanliness Using a Risk-Based Approachalmost 9 years ago
Formulating a Recipe for Bio/Pharma Career SuccessRelated 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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