Pharmaceutical analytical services

BU-NOT-SET

Employing sophisticated techniques and methodologies, analytical services not only validate the integrity of pharmaceutical products but also enable companies to fine-tune formulations, optimise manufacturing processes, and troubleshoot potential issues. With Recipharm’s analytical expertise you can be confident in the product you are bringing to trial and to the market.

Recipharm’s expert development support

We offer comprehensive support for method development, validation, impurity identification, stability studies, and release testing for clinical and commercial use. Our quality assurance adheres to regulatory standards from the European Pharmacopoeia, US FDA, cGMP, and ICH requirements.

Our experts provide:

Product characterisation and development
Impurity identification with advanced techniques like mass spectrometry, high-resolution mass spectrometry, preparative HPLC, and NMR analysis.
Global stability study support and release testing for Nitrosamines, E&L, and elemental impurities
Troubleshooting
Custom calculations
Strict timeline adherence

Recipharm’s broad array of services encompasses every aspect of analytical development, method validation and pharmacopeial testing including stability programme design and analysis, extractables and leachables (E&L), elemental impurities and nitrosamines testing.

Expert analytical method team

Our team develops hundreds of robust and transferable analytical methods every year to meet all of our clients’ varied needs. By harnessing our wealth of experience across diverse techniques, you can upgrade your analytical methods, enhancing efficiency and precision.

Analytical method validation

We can help you validate and verify your analytical methods, ensuring accuracy, reliability and compliance with the latest stringent regulations.

Pharmacopeial testing and verification

Our team has years of experience conducting meticulous pharmacopeial testing and verification, adhering to stringent regulatory requirements and industry standards.

Stability programme design and analysis

With our capacity, flexibility and extensive experience in handling vast stability programmes, we can design and analyse comprehensive stability studies, providing you with invaluable insights for your project. With more than 250 ongoing stability studies being conducted concurrently, we will support all your needs, helping you overcome resource challenges, reduce timelines and cut costs.

Extractables and leachables (E&L)

Mitigate risks associated with extractables and leachables by using our specialist expertise, ensuring the safety and quality of your products.

Elemental impurities testing

Our laboratory boasts the latest mass spectrophotometers and other advanced equipment, and employs scientists with decades of experience in this area. We can offer screening analysis designed to meet your specific needs covering all the elements listed in ICH Q3D and USP <232> as well as Ph.Eur 2.4.20.

Nitrosamines testing

Cutting-edge instrumentation and expertise enables us to conduct method development, validation and testing for nitrosamines. Leveraging a wide range of industry-leading tools including LCMS-MS, GCMS-MS, ICP-MS, ICP-OES, AAS, HPLC and GC, we guarantee the highest quality standards for your projects.