NMR investigations under GMP at ChemCon

GMP-compliant NMR analytics as a service – reliable, structurally confirmed, and fully documented

Nuclear magnetic resonance (NMR) spectroscopy is a central analytical technique in the pharmaceutical industry and an indispensable tool for the identification, structural confirmation, and purity assessment of active pharmaceutical ingredients (APIs). Under Good Manufacturing Practice (GMP) conditions, NMR analytics meets the highest requirements for reproducibility, documentation, and data integrity, thereby making a significant contribution to pharmaceutical quality assurance.

In a GMP-regulated environment, NMR spectroscopy is primarily used for identity confirmation of APIs, structural verification of API-related substances, and to support deviation and out-of-specification (OOS) investigations. The focus is not on exploratory research, but on standardized, traceable, and regulatorily compliant analytics.

A key feature of GMP-compliant NMR analytics is its high structural information content. Chemical shifts, signal shapes, integrals, and coupling constants generate characteristic spectra that serve as molecular fingerprints. Depending on the specific chemical question, different NMR nuclei are employed to selectively investigate functional groups, substitution patterns, or specific heteroatoms.

For GMP-compliant use, reproducibility of measurements is critical. This requires qualified NMR systems (IQ/OQ/PQ), controlled acquisition parameters, and clearly defined sample preparation procedures. Standardized solvents, concentrations, temperature conditions, and NMR tube types ensure comparability of spectra across different batches and over time.

Another central aspect is documentation and data integrity. GMP-compliant NMR investigations require complete traceability of all relevant information. This includes unambiguous sample identification, fully documented acquisition parameters, and the archiving of raw data (FID) and processed spectra in audit-trail-enabled systems. Compliance with the ALCOA(+) principles is essential.

Although NMR methods are frequently used for identity testing, their scope of application under GMP must be clearly defined. Acceptance criteria, evaluation concepts, and methodological limitations must be described in a transparent and traceable manner. Full quantitative validation is not required in every case; however, the intended use must be regulatorily justified.

At ChemCon, GMP-compliant NMR investigations for various nuclei are established and quality-assured. Analyses are performed on a qualified 400 MHz NMR system and are fully integrated into the existing GMP analytical infrastructure. ChemCon offers this NMR analytics as a service exclusively for pharmaceutical APIs and API-related substances.

The service offering is specifically aimed at customers from the pharmaceutical industry who require reliable identity and structural confirmation in an API context—for example during API development, GMP manufacturing, or batch-related quality control. Non-pharmaceutical applications or exploratory research analytics outside the API field are not part of the service portfolio.

Key advantages of GMP-compliant NMR analytics include non-destructive analysis, low sample consumption, and high structural information content. At the same time, methodological limitations must be considered, such as reduced sensitivity for trace-level impurities or challenges with heavily overlapping signals. In practice, NMR is therefore often used complementarily with chromatographic and mass spectrometric methods.

Overall, NMR spectroscopy under GMP represents a robust, versatile, and regulatorily established technique that makes a substantial contribution to the quality and safety of pharmaceutical APIs—both within internal quality control frameworks and as an external analytical service in a regulated environment.

Details about our NMR: