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Identity Testing at Goods Receipt

Fast. Reliable. According to Ph. Eur. 2.2.24 and USP– with the SweebIR FTIR spectrometer and the FIDES*Pharm software package.

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SweebIR: €9,900 net incl. diamond ATR, tablet and FIDES*Core

SweebIR FTIR spectrometer with diamond ATR and tablet

The task

Every active ingredient and every excipient must be clearly identified before processing.

With SweebIR and FIDES*Pharm, you carry out identity testing by FTIR-ATR spectroscopy in about one minute – directly at goods receipt, without sample preparation, without reagents and without KBr pellets. The method complies with the pharmacopoeia chapter Ph. Eur. 2.2.24 (infrared absorption spectrophotometry), and SweebIR meets the instrument requirements of Ph. Eur. and USP.

Reference spectra you can trust

At the heart of FIDES*Pharm is our own reference database. It consists mainly of EDQM chemical reference substances (CRS) and was recorded in-house under strict GLP rules on a qualified, pharmacopoeia-compliant FTIR reference spectrometer. The result: a traceable spectral comparison against references of known origin instead of libraries from unknown sources.

  • ✓  Documented online for every reference spectrum: reference substance, batch, measurement conditions, plus review and approval according to the four-eyes principle
  • ✓  The reference spectrometer and SweebIR both pass the instrument checks of Ph. Eur. 2.2.24 (polystyrene test of wavenumber and resolution) – reference and user spectra are directly comparable
  • ✓  Qualification documents of the reference spectrometer available on request or as part of an audit

The database is continuously expanded. If a substance is missing, please get in touch.

Apply sample. Measure. Release.

1

Place the substance on the diamond ATR crystal

2

Start the measurement on the tablet

3

Read the result and release

FIDES*Pharm automatically compares the spectrum with the reference and displays a clear result on the quality of the match. The measured spectrum remains visible and unaltered and can be compared visually with the reference at any time – transparent for analysts, quality assurance and authorities. A tissue is all it takes to clean: the diamond is scratch-resistant and chemically inert, and SweebIR is ready for the next sample within seconds.

Even closely related forms are reliably distinguished: Anhydrous citric acid typically reaches a match (determined by correlation coefficient) of 98–99 % with its reference, while different hydrate forms of the same substance score 10–15 percentage points lower – well below the acceptance limit.

For manufacturers, contract manufacturers and testing laboratories

SweebIR with FIDES*Pharm is suited to anyone who needs to test starting materials quickly and in line with the pharmacopoeia:

Pharmaceutical manufacturersContract manufacturersAPI and excipient distributorsPharmaceutical wholesalersHospital pharmaciesContract and testing laboratories

Thanks to its compact design (30 × 30 cm), the instrument can stand right where the goods arrive – and several instruments at different sites sharing the same database are easily possible.

~1 min

per identity test

Ph. Eur. + USP

instrument requirements met

EDQM CRS

reference spectra recorded under GLP

0 reagents

no KBr pellets, no accessories

Transparent costs. No surprises.

SweebIR costs €9,900 net – including diamond ATR, tablet and the FIDES*Core base software. Add FIDES*Pharm with the reference database for €39 per month; each additional package costs just €19 per month. No expensive reagents, no fragile accessories, no maintenance contracts for alignment.

Request a quoteBook an online demo