In October 2020, a complete device qualification of the AscendTM 400 MHz-NMR
(Picture 1) used by DSI-pharm was performed to achieve GMP ready status. This was carried out by GMP trained Bruker engineers and included testing the operation of the system to determine that it meets Bruker`s factory specifications as well as testing the computer system to ensure the requirements of 21 CFR Part 11.
Both, Bruker guidelines and the User Requirements Specification (URS) of DSI-pharm have been fulfilled to reach GMP compliance.
Using NMR as an analytical technique offers a rapid, convenient and cost effective method applicable to all steps of industrial processes (Table 2). Right from the beginning of the development phase through the test phase to the commercial production, all analytical methods in the pharmaceutical and biopharmaceutical industries must be carefully designed, appropriately validated and operated by trained and competent personnel. The dedicated NMR-Team of DSI-pharm knows how to help clients in analytical questions through every step of the pharmaceutical product development and in questions related to product controlling. DSI-pharm already proved its expertise e.g. in structure elucidation, purity determination (according to Ph. Eur. 2.2.33) or long term stability testing (Table 1).
Picture 1: Bruker Avance III HD 400 MHz equipped with a 5 mm PA BBI 400SI H-BB-D-05 Z probehead and a SampleXpress autosampler capable of containing up to 60 samples.
Table 1: Analyses done by DSI-pharm.
Table 2: Advantages of NMR spectroscopy.
Figure 1: 1H-NMR spectra of Dronabinol in MeOD-d4 using Mnova software.
Get in touch with our experts and benefit from this efficient technology!
Dr. Serap Acikgöz
General Manager Pharma DSI-pharm
Phone: +49 441 3613265 449
Serap.Acikgoez(at)tentamus.com
Source: https://www.dsi-pharm.de/en/dsi-pharm-achieved-gmp-compliance-for-400-mhz-nmr/