S-01 · Peptide testing

Purity, identity, sequence.
Signed and dated.

HPLC-UV and LC-MS/MS characterisation of synthetic peptides. Turnkey from receiving to certificate of analysis in 48 hours — the same method sheet, the same signatory, every submission.

Standard TAT
48 hr
LOD
0.05%
Sample req.
≥ 5 mg
Deliverable
Signed CoA
HPLC autosampler vials containing peptide sample solutions
Method · MA-S01-HPLC-01● Validated
Peptide purity assayHPLC-UV
Fig. 02 — Sample intakeHK · Kwun Tong
§ 01 — Assay scope

Assay scope

One vial is enough for the standard panel. Add-on tests share the same sample and shipment.

A-01HPLC-UV

Chromatographic purity

Reversed-phase HPLC-UV at 214 nm. Area-percent reporting with peak-integration audit trail.

A-02LC-MS/MS

Molecular mass

Intact mass by LC-MS/MS. Deconvoluted monoisotopic mass compared to theoretical.

A-03LC-MS/MS

Sequence confirmation

MS/MS fragmentation with b/y-ion coverage report. Modifications and truncations flagged.

A-04IC · KF

Counter-ion & moisture

TFA / acetate quantification and Karl Fischer moisture, on request. Impacts net-peptide mass.

§ 02 — Method sheet

MA-S01-HPLC-01

The abbreviated method sheet. The full validated method (system suitability, robustness, linearity) is available under NDA.

Method code
MA-S01-HPLC-01
Instrument
Agilent 1260 Infinity II · Binary pump · DAD
Column
C18, 4.6 × 250 mm, 5 µm, 100 Å
Mobile phase
A: 0.1% TFA in water · B: 0.1% TFA in ACN
Gradient
10 → 60% B over 25 min · 1.0 mL/min
Detection
UV, 214 nm (primary) · 254 nm (secondary)
Injection volume
10 µL of 1 mg/mL solution
Reference
ICH Q6A · Ph. Eur. 2.2.29
Reporting limit
0.05% area (unspecified impurity)
§ 03 — Sample submission

Sample submission

01

Quantity

Minimum 5 mg lyophilised solid per test. 10 mg preferred for full panel with retain.

02

Packaging

Amber glass vial, foil-sealed. Include theoretical sequence, MW, and known impurities on the submission form.

03

Shipping

Room-temperature courier accepted. Cold-chain optional. Chain-of-custody documented on receipt.

NDA-first · confidential by defaultClient portal upload · Signed CoA within 48 hr of receipt
§ 04 — Deliverable

A certificate you can hand to a regulator.

  • Method reference, instrument ID, and column lot on every CoA
  • Signed by an authorised technical signatory (not the analyst)
  • Raw chromatograms and integration parameters retained 5 years
  • Batch-uniqueness verified — reports carry a QR-verified serial
  • Reissue-controlled — every revision superseded, never overwritten
Submit a peptide

Quote in 24 hr. CoA in 48.

IntakeArrow us the sequence and quantity. We reply with a scoped quote, submission form, and shipping label.

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