What does a Certificate of Analysis include?

Each per-lot COA includes the HPLC chromatogram (area-percent purity at 220 nm against a reference standard), the ESI mass-spectrometry trace confirming molecular weight to within ±1 Da of theoretical, the LAL endotoxin assay result (target <0.5 EU/mg), the synthesis batch number, the release date, and the storage and stability profile.

Why does the test lab need to be independent from the synthesis lab?

A laboratory is structurally incapable of catching its own systematic errors. Releasing on the strength of an in-house COA means contamination, byproducts or potency drift introduced by the synthesis process can pass undetected. An independent ISO 17025-accredited contract laboratory provides the verification.

What is the release threshold for HPLC purity?

Every lot must hit at least 99.0% area-percent purity at 220 nm against the reference standard before release. Lots that fail are rejected and the synthesis batch is investigated.

How long are lyophilized peptides stable in shipping?

Sealed lyophilized vials are stable for several weeks at room temperature in the dark, 12 months at +4 °C, and 24 months at −20 °C. Ambient shipping is appropriate for the freeze-dried form.

Quality Workflow

The COA is not a marketing document. It's the release condition.

Q: Why does the test lab need to be independent from the synthesis lab?

A laboratory is structurally incapable of catching its own systematic errors. Releasing on the strength of an in-house COA means contamination, byproducts or potency drift introduced by the synthesis process can pass undetected. An independent ISO 17025-accredited contract laboratory provides the verification.

Q: What is the release threshold for HPLC purity?

Every lot must hit at least 99.0% area-percent purity at 220 nm against the reference standard before release. Lots that fail are rejected and the synthesis batch is investigated.

Q: How long are lyophilized peptides stable in shipping?

Sealed lyophilized vials are stable for several weeks at room temperature in the dark, 12 months at +4 °C, and 24 months at −20 °C. Ambient shipping is appropriate for the freeze-dried form.

Three independent assays, one external lab, no exceptions. If a lot doesn't pass, it doesn't ship — and the synthesis batch is rejected.

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3Independent assays

≥ 99%HPLC purity floor

< 0.5EU/mg endotoxin

Reverse-phase HPLC

C18 column, gradient elution, UV detection at 220 nm. Reported as area-percent purity against a reference standard. Release minimum: 99.0%. The chromatogram travels with every shipment.

ESI Mass Spectrometry

Electrospray ionisation MS in positive mode. Confirms molecular weight to within ±1 Da of the theoretical value. Detects truncations, byproducts and contamination invisible to HPLC alone.

LAL Endotoxin Assay

Limulus Amebocyte Lysate testing. Release ceiling: 0.5 EU/mg, well below the 5 EU/mg pharmacopoeial limit. Critical for any in-vitro work that touches a live cell line or primary culture.

Storage & Stability

What you do once the vial arrives.

Lyophilized peptides are surprisingly robust at ambient. Once reconstituted they are not. The same instructions ship with every order, and we'll restate them here.

Before reconstitution

Sealed lyophilized vials are stable for 24 months at −20 °C, 12 months at +4 °C and 4 weeks at room temperature in the dark. Shipping at ambient is fine.

Reconstitution

Bacteriostatic water (0.9% benzyl alcohol) for routine work; sterile saline or acetic acid (0.6%) for sensitive sequences. Inject solvent down the vial wall, swirl — don't shake.

After reconstitution

Use within 14–28 days at +4 °C depending on the sequence. For longer storage, aliquot and freeze at −80 °C — avoid freeze-thaw cycles, they degrade most peptides quickly.