Application note: Nitrosamines in drug product by HRAM-LCMS
HPLC with HRAM MS method for the determination and quantitation of nitrosamine impurities in drug products consistent with FDA requirements.
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Whitepapers & App Notes
Brochure: Thermo Scientific Charged Aerosol Detectors
Charged aerosol detection is a technique capable of measuring any non-volatile and many semi-volatile species in a pharmaceutical applications.
Application note: Neutralisation efficiency of ICR swabs
This application note shows the neutralisation efficiency of ICR swabs for sanitsed surfaces in aseptic manufacturing environments.
Application note: Detection of contamination from gloves
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.
Whitepaper: Rapid sterility testing: a new solution for short shelf life products
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.
Application note: Influence of environmental sample pre-storage
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).
Brochure: Capsugel® R&D portfolio
The Capsugel® R&D portfolio features capsule and related service solutions for faster research and development during pre-clinical and clinical stages.
Article: Pharma Analysis & QC – Analytix Reporter special edition
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.
Case study: Implementation of the SmartCR in an aseptic processing facility
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
Whitepaper: Leveraging the patient journey to optimise injection device use at home
With the growing trend of injection device use at home, the device optimisation is essential to increase patient safety during self-administration.
iPDF: Complete solution for your sterility testing workflow
Extensive portfolio of quality control solutions. Full regulatory compliance (USP, EP, JP Pharmacopoeias) of your sterility testing workflow.
Application note: Analytical methods in cleaning validation
A typical cleaning validation (CV) programme consists of three phases: Design, Validation and Continued Verification.
