Application Note: Stearates verification using a handheld Raman analyzer
In this application, a Principal Component Analysis (PCA) method was found to be successful in identifying the various stearates...
List view / Grid view
Whitepapers & App Notes
Application note: Representative sampling in process Raman spectroscopy
Raman spectroscopy is an analysis technique that provides a “molecular fingerprint” of the sample, enabling analysis of chemical composition and molecular structure without sample preparation..
Whitepaper: Meeting modern data integrity and compliance requirements
FDA was perhaps understating a point when it said in its April 2016 Draft Guidance: Data Integrity and Compliance with cGMP that the increasing number of data integrity-related cGMP violations identified during its inspections was ‘troubling’...
Whitepaper: Dwell Volume and Extra-Column Volume: What are they and how do they impact method transfer
Method transfer or method scaling across different instrument platforms can be affected by both dwell volume and extra-column dispersion...
Whitepaper: Improved aseptic processes and monitoring to reduce FDA 483s
In recent years, the FDA response to companies with insufficient proof of control over their production has become more aggressive...
Application Note: The characterisation of polymorphs by thermal analysis
TGA-FTIR was used to characterize and distinguish between different polymorphs...
Whitepaper: Extractables and leachables testing – A risk based approach
Pharmaceutical products are in contact with many external components during both manufacture and usage and small amounts of chemicals may leach from these components with a potential health risk to the patient...
Whitepaper: Data Integrity: Technical controls that demonstrate trust
Using Chromeleon 7 Chromatography Data System for enhanced data integrity...
Whitepaper: Downstream biopharmaceutical operations
The work presented here investigates the development and application of new bioprocess analytics in accordance with the aims of QbD...
Whitepaper: Nitrosamines: analysis for extractables and leachables
This selective detection method greatly improves the prospect of detecting nitrosamines in pharmaceutical products and medical devices that incorporate rubber or latex...
Whitepaper: Key to outsourcing method development and validation: A pragmatic approach
In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developer’s mind set and a regulatory background in validation...
Application note: Verification of pharmaceutical raw materials using the Spectrum Two N FT-NIR Spectrometer
In this application note, PerkinElmer describes how the Spectrum Two N™ FT-NIR spectrometer can be deployed using a workflow approach, suitable for a regulated environment, to overcome a range of different challenges in raw material identification...
Whitepaper: SWILE pick & decision dispense
The SWILE technology is the first fully automated true one-to-one gravimetric "pick & decision dispense" of compounds...
Whitepaper: Regulatory compliance in pharma – software requirements and solutions
In this whitepaper, Metrohm discuss the standardisation organisations put forward for analytical instruments requirements with a focus on software...
Application note: Raman Imaging: A powerful tool for the label-free characterisation of single cells and bacteria
With confocal Raman imaging the molecules of a sample can be chemically identified and their distribution can be imaged three-dimensionally...
