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FTIR raw-material identification

In short

Fourier-transform infrared (FTIR), per USP <197> and <854>, is the bench-top fingerprint identity test for supplement raw materials where the molecule has a discriminating IR spectrum (amino acids, minerals as carbonates/citrates, synthetic vitamins, taurine, creatine). ATR-FT...

Fourier-transform infrared (FTIR), per USP <197> and <854>, is the bench-top fingerprint identity test for supplement raw materials where the molecule has a discriminating IR spectrum (amino acids, minerals as carbonates/citrates, synthetic vitamins, taurine, creatine). ATR-FTIR is the standard format because it needs no sample prep, runs in seconds, and produces a comparison-to-reference pass/fail that holds up under 21 CFR 111.75 identity scrutiny.

Regulatory anchors
  • USP <197>
  • USP <854>
  • 21 CFR 111.75
How V5 handles it
QMS — quality records next to the work they concern.
Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.
Document control — one version in force, every change signed and explained.
Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.
Related terms
NIR rapid raw-material identityComponent identity confirmation (21 CFR 111.75)
Software that covers FTIR raw-material identification
V5 Ultimate (Dietary Supplements)
V5 Ultimate runs Master Manufacturing Records and executed Batch Production Records under 21 CFR Part 111, with mandatory…
V5 Ultimate Dietary Supplements
Written for supplement contract manufacturers and brand owners tired of surviving FDA 483s on paper.
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