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HPLC with HRAM MS method for the determination and quantitation of nitrosamine impurities in drug products consistent with FDA requirements.
Charged aerosol detection is a technique capable of measuring any non-volatile and many semi-volatile species in a pharmaceutical applications.
This application note shows the neutralisation efficiency of ICR swabs for sanitsed surfaces in aseptic manufacturing environments.
This application note shows the detection of low numbers of different bacterial test strains from Neoprene® gloves.
Application note: Online cleaning validation for real-time equipment release using total organic carbon, inorganic carbon, and conductivity data
Cleaning validation is an important element to cGMP manufacturing to ensure purity, quality, and potency of drug product.
All drug products have to undergo sterility testing to comply with Good Manufacturing Practices (GMP). Rapid sterility testing, which offers an incubation period of five days or less, provides a solution.
The manufacturing process does not always allow for immediate transfer of samples to the incubator space and may be pre-stored.
Whitepaper: Establishing the proper alcohol/water proportion for simulating solvents used in controlled extraction studies
This paper provides scientific guidance as well as a case study on the effect of solvent polarity (ethanol/water proportion) on the levels of extractables.
Whitepaper: Establishing the proper PH range for aqueous simulating solvents used in extractables profiling
This whitepaper considers the chemical properties of commonly encountered acidic and basic extractables and uses these properties to address questions about establishing the proper pH (or proper pH range).
The Capsugel® R&D portfolio features capsule and related service solutions for faster research and development during pre-clinical and clinical stages.
Biologics continue to be a major modality in the pharmaceutical pipeline. New and unique LC-MS tools will become available for use from discovery through QC.
Airflow reduction and energy savings achieved in HVAC compared to conventional systems. The challenge of reducing HVAC energy consumption and operation costs without negatively affecting the quality of the finished products, ensuring cleanrooms always conform to required specifications
With the growing trend of injection device use at home, the device optimisation is essential to increase patient safety during self-administration.
Extensive portfolio of quality control solutions. Full regulatory compliance (USP, EP, JP Pharmacopoeias) of your sterility testing workflow.