cGMP NMR Services
NMR studies have traditionally been reserved for research and development purposes assisting in the study of molecular structure, molecular interaction and profiling chemically and biologically relevant molecular dynamics. These applications require careful sample preparation, extensive data acquisition and detailed data analysis and consequently, NMR is often underutilized due to resource limitations.
Recently, NMR’s unique advantages in specificity, linearity and quantitation combined with ease of method development are being recognized as useful frontline tools in maintaining quality and safety of food, pharmaceuticals and medical devices. The application of NMR methods in these areas requires adoption of additional level of controls (cGMPs) to assure the quality and integrity of resulting data.
cGMP NMR at Novatia
Novatia provides a full range of cGMP NMR services and custom method development.
Quantitative NMR to accurately measure purity is available by Novatia’s pre-qualified method (TM-002, One Dimensional 1H NMR Spectroscopy Test Method). We offer rapid turnaround of high-accuracy quantitation for purity/potency determinations with a certificate of analysis (click here to download a quotation).
PLEASE NOTE: Novatia’s qNMR method is not suitable for high MW (>1000 dalton) or polymeric compounds. Applications include: reference standard purity and HPLC relative response factor (RRF) determinations.
Compendial Test Methods
|Method Purpose||Substance Analyzed||Acceptance criteria|
|USP Identity tests||Amyl nitrite|
|Similar to USP Standard|
Polyoxyl 10 Oleyl Ether
Polyoxyl 20 Cetostearyl Ether
|Measurement of specific groups|
Example: Enoxaparin Sodium – USP 13C NMR Identity Test
Enoxaparin is a low molecular weight heparin analogue used to prevent blood clotting. The USP monograph lists a series of tests for qualifying the release of Enoxaparin Sodium API to the pharmaceutical market. One of these is a 13C NMR identity test that compares the Enoxaparin USP reference standard with a test Enoxaparin sample.
Novatia is uniquely positioned to perform the 13C NMR Enoxaparin USP Identity test under cGMP because of our high sensitivity 13C cryroprobe
The top portion in the figure below shows a typical 13C spectrum of Enoxaparin Sodium while the bottom shows an example of 13C spectrum of USP Enoxaparin Sodium acquired on Novatia’s system in 1 hour. Because, Novatia’s 500 MHz NMR system is equipped with a Bruker BBO Prodigy Cryoprobe, these data are collected 16 times faster than on conventional NMR systems. Rapid data acquisition coupled with our robust quality system and highly experienced NMR staff means customers receive high quality results faster.
The FDA has issued non-binding recommendations for characterizing Low Molecular Weight Heparins (LMWH) by 2D NMR.
Novatia has been providing NMR services for nearly 15 years. With three NMR specialists with combined research experience of over 100 years and newly updated 500 MHz NMR instrumentation, we are uniquely positioned to assist our customers in compendial NMR assays, developing new cGMP NMR assays and transferring established assays to our laboratory.