Case study: GC-MS for cGMP nitrosamine testing
What pharmaceutical QA/QC laboratories need to know to overcome the challenges of nitrosamine impurities in drugs for cGMP testing.
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Whitepapers & App Notes
Whitepaper: The new age digital contract research organisations
The ideal CRO digital platform offers an opportunity to un-burden bureaucracy and drive data capture and integrity straight into the digital eco-system allowing earlier intervention.
Application note: Setup and transfer of a gradient HILIC method
A fast and reproducible gradient HILIC method was set up for the impurity analysis of the hydrophilic temozolomide.
Supplement: ACC endotoxin
The launch of ACC's PyroSmart NextGen™ recombinant Cascade Reagent (rCR) marks the introduction of a new sustainable recombinant LAL reagent technology for bacterial endotoxin testing (BET).
Technical bulletin: Nitrosamine control: understanding the new FDA and EMA regulations
This technical bulletin discusses major regulatory updates, introduced by the FDA and EMA, regarding nitrosamines and SGS proposed risk assessment method for compliance.
Application note: Solving the aggregation problem of HEK 293 cells
In this application note, we show a successful example of the adaptation of a human recombinant protein-expressing HEK293 cell line.
Whitepaper: Sterile formulation strategies to shorten timelines
This whitepaper reveals strategies to create simple, stable formulations for your sterile injectable, a solid foundation for your product’s lifecycle.
Case study: Results from bridging data management gaps
How CMC software helped a major pharmaceutical company improve process development and regulatory submissions.
Brochure: PyroSmart NextGen™
The launch of ACC's PyroSmart NextGen™ recombinant Cascade Reagent (rCR) marks the introduction of a new sustainable recombinant LAL reagent technology for Bacterial Endotoxin Testing (BET).
Technical note: The content of nevirapine and related impurities
Guidance on generating an intelligent, automated workflow for batch-release analysis of an active pharmaceutical ingredient (API).
Brochure: Simplify your compliance process
Find out how to simplify your compliance process and connect data from multiple stakeholders with SAP Advanced Track and Trace for Pharmaceuticals.
Whitepaper: USP method modernisation
How ion chromatography can help to modernise and simplify out-dated USP methods for ion analysis.
Infographic: Reproducibility and speed in PCR
To achieve stable and reproducible results can be a challenge in PCR. This document shows facts you should consider when purchasing a PCR cycler.
Application note: Catalyst screening in drug development
Learn how to design, plan, execute and analyse catalyst screening experiments in an efficient manner.
Application note: Impurity analysis of L-aspartic acid and glycine
Simultaneous detection of amino acids and organic acids by a single method, therefore reducing analysis time and costs.
