Raw material and API identity, assay, residual solvents and water testing
Incoming-goods verification is where a supplier certificate meets an independent number. We confirm identity by mass spectrometry, assay against a reference standard, and run the compendial residual-solvent, water and elemental-impurity tests that a release specification calls for.
- From
- $129
- Turnaround
- 5–7 business days
- Certificate
- Public, hashed, video-linked
What the panel measures
| Test | Method | Instrument | Reports as |
|---|---|---|---|
| Identity | MethodLC-MS/MS or GC-MS vs reference | InstrumentAgilent 6490 Triple Quadrupole LC/MS | Reports asConfirmed / not confirmed |
| Assay | MethodHPLC-UV vs certified reference | InstrumentAgilent 1290 Infinity II UHPLC | Reports as% w/w |
| Residual solvents | MethodUSP <467> headspace GC-MS, Class 1, 2, 3 | InstrumentAgilent GC-MS with headspace | Reports asppm vs USP limits; add-on $179 |
| Water content | MethodKarl Fischer coulometric | InstrumentKarl Fischer titrator | Reports as% w/w; add-on $49 |
| Elemental impurities | MethodUSP <232>/<233> ICP-MS | InstrumentAgilent 7850 ICP-MS | Reports asµg/g vs PDE; add-on $169 |
| Endotoxin | MethodUSP <85>, Charles River-calibrated cartridges | InstrumentCharles River Endosafe nexgen-PTS, three units | Reports asEU/g; add-on $199 |
Accepted: API powders Excipients Intermediates Bulk peptide raw Solvents and reagents
Compounds: Small-molecule APIs Bulk peptides Cellulose and starch excipients Magnesium stearate Solvents
Why the method matters
Compendial methods, cited by chapter
Residual solvents by USP <467> headspace, water by Karl Fischer, elemental impurities by <232>/<233>. Each line on the certificate names the chapter and the instrument so your QA reviewer can map it to the specification.
Authentic Agilent bench, OEM consumables
Every instrument was bought new through Agilent, Charles River and MilliporeSigma authorized channels, installed and performance-qualified by certified engineers, and serviced by Quantum Analytics. Columns, lamps, seals, cartridges, canisters and reference standards are OEM or Thermo Fisher lot-traced; no third-party refills, no re-used cartridges, no expired lysate. The instrument ID, column lot and standard lot are printed on every certificate.
The bench this runs on
Agilent 6490 Triple Quadrupole LC/MS
Identity by accurate mass and MRM transitions; sub-ppt quantitation with isotope dilution.
Agilent 1290 Infinity II UHPLC
Purity and potency by UV; 1300 bar, sub-2 µm columns, chromatogram printed on the certificate.
Agilent GC-MS with headspace
Volatiles, residual solvents, BTEX and semivolatiles by EI mass spectrometry.
Karl Fischer titrator
Water content of lyophilised peptides and raw materials.
Agilent 7850 ICP-MS
Elemental impurities and toxic metals to sub-ppb, internal-standardized.
Charles River Endosafe nexgen-PTS, three units
Rapid USP <85> endotoxin on single-use cartridges; each cartridge is calibrated and certified by Charles River, with the standard curve and positive product control built in.
Purchased new through authorized channels, installed and performance-qualified by certified engineers, run on OEM consumables. Instrument IDs are printed on every certificate. See the full bench.
Raw material testing compared
| Gold Standard Analytics | Typical | |
|---|---|---|
| Residual solvents by headspace GC-MS | Gold Standard AnalyticsYes, USP <467> | TypicalOften GC-FID or outsourced |
| Water by Karl Fischer | Gold Standard AnalyticsYes | TypicalLoss on drying substitute |
| Elemental impurities | Gold Standard AnalyticsICP-MS <232>/<233> | TypicalHeavy metals <231> colorimetric |
| Public certificate | Gold Standard AnalyticsYes | TypicalNo |
Named, sourced comparisons with individual laboratories are on the compare page.
Questions about raw materials testing
Can I see the video of my sample being opened?
Yes. Every package is opened on camera, each container is photographed, and the footage is linked to your accession. Custody video and photos are kept for three years; the retained sample itself is kept 90 days for guarantee retests.
What happens if my result fails?
It is published like any other result, with the method, instrument and specification shown. You may order a retest of the retained sample; we never re-run to obtain a better number.
How much material?
500 mg covers identity and assay. Residual solvents and water each consume about 200 mg more.
Can you test against my specification?
Yes. Send the specification with the order and the certificate reports each result against your acceptance criteria.
Do you do full USP monograph testing?
We run the monograph tests within our scope: identity, assay, residual solvents, water, elemental impurities, endotoxin. Tests outside scope are stated as not performed rather than subcontracted silently.
Method references: USP <467> Residual Solvents · USP <233> Elemental Impurities Procedures
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Submit a sample
An invoice is issued at submission and the prepaid label is emailed when payment lands. Certificates publish in 5–7 business days.