Six assays. One incoming-material receipt.
We mirror the supplier COA against orthogonal in-house assays. If a drum says 99.2 % and we see 94.8 %, you know before it hits your formulation line — not at the customer-complaint step.
Published. Per-test.
No quote calls.
Every assay a la carte, every panel bundled. Bulk discount at 5+ samples. Prices below reflect a single-compound submission.
LC-MS or FTIR identity confirmation against the supplier spec. The minimum check before a drum opens.
- LC-MS or FTIR identity
- Observed m/z or spectral match
- Pass / fail determination
- Public COA + accession #
LC-MS identity + HPLC purity + Karl Fischer moisture + heavy metals scan. The standard incoming-material panel for QC.
- LC-MS identity confirmation
- HPLC purity assay
- Karl Fischer moisture
- ICP-MS heavy-metal scan
- Certificate of Analysis
Identity + assay + USP <467> residual solvents + extended heavy metals + signed Certificate of Conformance. cGMP audit-ready.
- Everything in Identity + Assay
- USP <467> residual solvents
- Extended heavy metals (15-element)
- Microbial limits (USP <61>)
- Signed Certificate of Conformance
Where incoming-material QC catches problems.
Supplier-lot drift, mislabeled drums, and recrystallization-residue carryover are the most common reasons a finished-product COA fails. Catching them at incoming inspection is an order of magnitude cheaper than at customer complaint.
USP, ICH, FDA cGMP — the supplier audit standard.
Raw-material testing is contract-driven. We map every assay to the standard the buyer or auditor references in the purchase order.
USP elemental-impurity Permitted Daily Exposure limits for Pb, Cd, As, Hg in pharmaceutical-grade material. Extended catalyst-residue panel (Pd, Pt, Rh) follows the same PDE methodology.
Class 1 (avoid: benzene, CCl4, 1,1,1-trichloroethane), Class 2 (limit: hexane, methanol, dichloromethane, etc.), Class 3 (low risk: ethanol, acetone, ethyl acetate at 5,000 ppm). Our GC-MS HS method covers all three classes in a single run.
ICH thresholds for reporting (≥ 0.05 %), identification (≥ 0.10 %), and qualification (≥ 0.15 %) of impurities. Q3D for elemental impurity PDE limits. Our HPLC method reports any peak above 0.1 % area; impurities above 0.5 % get individual MS identification.
Mandatory identity testing of incoming components per § 211.84. Our Identity panel ($129) provides the documentation a finished-pharma manufacturer needs to satisfy this regulation per lot.
USP guidance for verifying that a pharmacopeial procedure performs as intended in the testing lab. We document method-suitability data on every USP-method COA so downstream auditors can trace performance.
Yes. SLA pricing for production-cadence QC kicks in at 20+ lots/month; volumes above 100 lots/month qualify for net-30 contract pricing with dedicated batch turnaround. Reach out with your monthly volume and we’ll structure a contract.