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Mass Spectrometry

Mass spectrometry LIMS for impurities and characterization

Nitrosamines, elemental impurities, extractables and leachables, and biologic characterization by LC-MS and ICP-MS, with results that evaluate against regulatory limits.

THE PROBLEM

Where legacy LIMS break down

Mass spec in QC is where the regulatory limits are tightest and the data is heaviest. Nitrosamine limits are in nanograms, elemental impurities have per-element PDEs by route of administration, and E&L screens generate library matches that someone has to adjudicate.

The instrument software does the science and the LIMS is supposed to hold the result against the limit. In most labs this step is a transcription plus a lookup plus a judgment call, repeated for every element or analyte, creating room for manual error.

Conversely, Labbit holds the limits as controlled data, evaluates every quantitation against the right limit for the product and route automatically, and links the result to raw data and internal standard performance so the record is audit-ready without assembly.

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PRE-CONFIGURED WORKFLOWS

Workflows out of the box

Built visually in BPMN, adapted to your lab, and changed without a vendor release.

Nitrosamine Impurities by LC-MS/MS; Elemental Impurities by ICP-MS; Extractables & Leachables; Host Cell Protein by LC-MS; Intact Mass Analysis; Peptide Mapping; Released Glycan Analysis
Targeted Amplicon Sequencing

Instruments and platforms

Instruments and platforms

Sciex Triple Quad 7500; Agilent 6495 and 6545XT; Waters Xevo; Thermo Orbitrap Exploris; Agilent 7900 ICP-MS; Thermo iCAP RQ; PerkinElmer NexION
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FAQ

Frequently Asked Questions

Does Labbit handle nitrosamine testing to current limits?

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Yes. Nitrosamine quantitation by LC-MS/MS evaluates against the applicable FDA and EMA acceptable intake limits, with internal standard tracking and raw data linkage.

Can Labbit apply per-element PDE limits for elemental impurities?

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Yes. USP 232 and 233 workflows evaluate each element against the PDE for the product's route of administration.

Which mass spectrometers are integrated?

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Sciex Triple Quad, Agilent 6495 and Q-TOF, Waters Xevo, Thermo Orbitrap, and ICP-MS from Agilent, Thermo, and PerkinElmer.

Is biologic characterization supported?

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Yes. Intact mass, peptide mapping, released glycan, and host cell protein by LC-MS are pre-configured for biologic identity and comparability.

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SEE IT ON YOUR ASSAYS

See your workflow running in Labbit

Bring an assay your team runs today. We’ll show you how it’s configured, executed, and reviewed.