PharmaCore® - GMP Facility

GMP Analytical--Reference Standard Qualification

PharmaCore is uniquely positioned to synthesize as well as characterize and qualify your reference standards. Our team of experienced scientists can characterize your reference standards following your analytical methods, specifications, and requirements. Or, utilizing good scientific judgment, we will choose appropriate methods to assess chemical mass balance.

The analytical techniques we use to qualify reference standards include but are not limited to:

Elemental Analysis
NMR (1H, 13C, etc.)
HPLC (specific methods or area normalization)
GC using flame ionization detection with direct injection or static headspace analysis (specific methods or area normalization)
DSC
Loss on Drying
Karl Fischer water determination in conjunction with Residul Solvents testing
Heavy Metals
Residue on Ignition
XRPD

A detailed report of the procedures used and the results obtained for your reference standard is provided as well as a certificate of analysis to summarize the data.

PharmaCore's scientists bring a wealth of real-world experience to the table to help meet your needs. Our analytical operations are based on written, detailed SOPs and stringent quality assurance practices, and all of our work is performed in compliance with cGMP requirements.

For more information on our reference standard qualification capabilities or any of our pharmaceutical capabilities, please call PharmaCore at 336-841-5250, extension 159 (Mark Shapiro, Director GMP Analytical) or extension 101 (Kelly Tilyard, Marketing Manager).