1) Method development, validation and routine testing for elemental impurities in raw materials, excipients, APIs and finished products.
2) Why choose elemental impurities testing from IRLPL?
3) We offer guidance throughout the entire process, from identifying elements to determining limits.
4) We help determine if quantitative or qualitative testing is needed, whether to test APIs or finished drug products, and assist in managing challenges from EP, USP, and ICH Q3D.
5) Additionally, we define required impurities and limits for testing, offer customized screening for elemental impurities, and provide solid risk assessments where additional data is needed.
6) We can also assist with combining drug products and setting specifications for addition type testing over a range.
7) Being a global leader in analytical chemistry services, we possess the professional expertise and regulatory qualifications needed to conduct method development, method validation, and routine testing for all your elemental impurities requirements. With extensive experience in compendia proposed methodology, our highly qualified staff is always updated on the evolving requirements and are ready to implement new testing.
We provide:
1) Multiple locations across Europe, Asia and USA
2) Instruments, including ICP-OES & ICP-MS.
3) Closed vessel microwave digestion
4) Experience with overcoming interferences (physical, chemical, spectral, isobaric, polyatomic)
5) Long-time experience in method development and validation
6) Verification of Pharmacopeia methods
7) Experience with a huge variety of different sample types and complex sample matrices
Get in touch with IRLPL today to discover how our expertise in elemental impurities can assist you in meeting regulatory requirements.