minispec Form Check

Easy-to-use benchtop system meets the analytical power of NMR to determine the ratio of either different drug components or various solid forms in a substance.

Quantitation of components in solid mixtures like formulated materials is crucial in material sciences. Especially in the pharmaceutical industry, API (Active Pharmaceutical Ingredient) form characterization and quantification play a central role from early drug development to manufacturing, including knowing how the presence of these solid forms is influenced by the production and storage of drugs, as well as interactions with excipients. Current API quantification methods can be expensive, require laborious calibrations or lack accuracy.

Bruker makes use of reliable and affordable TD-NMR (Time-Domain Nuclear Magnetic Resonance) to monitor phase purity and quantify physical API forms including amorphization. The patent pending minispec Form Check uses ¹H or ¹⁹F relaxometry data as fingerprints for expected components in solid mixtures, superseding excessive calibration, delicate sample preparation and a high level of expert knowledge.

 

• Uses the minispec mq20 benchtop instrument: small foot print, cryogen-free, versatile, low cost of ownership
• ¹H and ¹⁹F setups available
• Choose between 10 mm or 18 mm diameter glass tubes
• Variable temperature (+5 to +65°C) available with the 10 mm option
• Upgrade to research mode to develop your own experiments
• Patented analysis included in Bruker's well established Dynamics Center
• Sample automation upgrade possible

• Accurate phase quantification of the API lead form in the presence of other polymorphs or excipients, incl. amorphous quantification
• No requirements regarding sample texture or homogeneity (tablets, gels, polymers), drug loading
• Benchtop system: low footprint & costs
• Ease-of-use: non-expert workflow from calibration to project report
• Minimal sample preparation
• Straightforward & fast calibration
• Automated patent pending quantification analysis
• Non-destructive & non-invasive: samples can be re-used for other purposes

Measured on the minispec mq20 benchtop TD-NMR instrument, the proposed minispec Form Check enables quantification by comparing ¹H or ¹⁹F T1 saturation recovery curves (SRC) of the pure components or even excipients with those of the analyte of interest. The novelty of the approach is that a full relaxation time analysis, which is often prone to errors, is not required. Instead a linear combination of the reference SRCs is fitted to the SRC of the mixture. The coefficients of this linear combination directly translate to the relative mass percentages of the pure components. Dependent on the relaxation properties of the components, the method accuracy can go down to half a percent.