Application note: An alternative method of drug‑excipient characterisation
An alternative test method that enhances detection of incompatibilities by significantly reducing testing time, improving testing throughput and reducing operator effort.
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Whitepapers & App Notes
Application note: Comprehensive fractionation of herbal medicine components by PDA-ELSD-triggered preparative LC
This article introduces a comprehensive fractionation method for both UV absorbing and non-UV absorbing compounds.
Application note: Taxonomic traceability for bacterial and fungal entries in Accugenix® reference databases
When you are reviewing bacterial and fungal isolates, do you appreciate that the names given to these organisms are regulated?
Application note: BIOBALL® Burkholderia cepacia complex strains performance testing for USP <60> growth promotion requirements
Over the years, the presence of objectionable microorganisms has been identified as the leading cause of non-sterile drug product recalls in the US.
Whitepaper: UDI – from the basics to the benefits
Get the most detailed information about UDI – requirements, implementation and benefits. Everything that supply chain participants need to know!
Product hub: 3P® connect EM-BODY connectivity
3P CONNECT is your EM partner for data compliance and process efficiency, for reliable decision making and taking control of your EM.
Whitepaper: CMC regulatory landscape, cell and gene therapy products
This whitepaper gives an understanding of the evolving regulatory guidelines for cell and gene therapies, in order to bring them to market faster.
Whitepaper: Aggregation – the next logical step
Discover why pharmaceutical companies should consider aggregation as the next step towards supply chain drug traceability.
Catalogue: ACC products & services
Associates of Cape Cod, Inc. (ACC) has been a global leader in endotoxin and (1→3)-ß-D-glucans detection products and services for nearly 50 years.
Technical paper: Low risk frozen distribution of SU bags for bioprocessing
This paper discusses the results of a study that help to mitigate the risks during frozen shipping and ensure consistent product quality in cold chain.
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.
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.
