— Quality

Spec is the promise.
Data is the proof.

Every peptide API is built, tested, and released against a published specification. Validated methods, ICH-aligned stability, and a signed Certificate of Analysis follow every drum — no exceptions, no shortcuts.

Get Pricing Request a CoA

≥ 99%

Typical HPLC purity

100%

Lots shipped with CoA

21 CFR

210 / 211 cGMP

ICH Q1A

Stability program

— 01 / Method Validation

Every method proven before it releases a lot.

Analytical methods are qualified per ICH Q2(R2) — specificity, linearity, accuracy, precision, LOD/LOQ, and robustness — before they release any commercial material. Validation packages are available under CDA.

HPLC-UVPurity & related substances
LC-MSIdentity confirmation
Karl FischerWater content
GC-HSResidual solvents (ICH Q3C)
LALBacterial endotoxin
ICP-MSElemental impurities (ICH Q3D)

HPLC-UV · 214 nm

Chromatogram — Semaglutide, Lot 2026-A047

Purity 99.4% · RT 8.62 min

99.4%

Main peak

0.6%

Total impurities

Peaks resolved

— 02 / Release Testing

Six checks. One signature. Zero exceptions.

Nothing leaves the facility until every panel result is on the CoA and a qualified person has signed the release. If a single parameter falls off spec, the lot is quarantined — not shipped.

Release panel

Per-lot QC coverage — validated methods

All tests · signed by QA

Identity

LC-MS

Conforms

Purity

HPLC-UV

99.4%

Water

Karl Fischer

3.1%

Residual solvents

GC-HS

< ICH Q3C

Endotoxin

LAL

< 0.5 EU/mg

Appearance

Visual

White powder

Lot-to-lot · n=12

Purity consistency across recent lots

Spec ≥ 98.0%

99.2%

Mean purity

σ 0.28

Std deviation

12/12

Lots on spec

— 03 / Lot Consistency

The number on the page is the number in the drum.

Twelve consecutive lots on the same molecule, released to the same spec, with a standard deviation you can plan a formulation around. Consistency isn't a target — it's the audit trail.

Retention samples are held for every lot. Historical CoAs are available on request for material you've received from us.

— 04 / Stability

Every SKU on an ICH-aligned
stability program.

Long-term (5 °C ± 3 °C) and accelerated (25 °C / 60% RH) conditions per ICH Q1A(R2). Assay, related substances, water, and appearance pulled at defined timepoints. Every lot carries a retest date on its Certificate of Analysis.

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ICH Q1A(R2)
Long-term & accelerated conditions
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Retest dating
Assigned per SKU, printed on every CoA
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Retention samples
Held to end of retest + 12 months
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Trending
Reviewed at annual product review

24-month · 5 °C ± 3 °C

Stability — assay retention & total impurities

Semaglutide · n=3 lots

Assay retentionTotal impurities

— 05 / Certificate of Analysis

Every drum. Every lot. Every time.

A specimen CoA is shown below. The real document ships with every order and is traceable to raw materials, batch record, and the qualified person who released it.

Specimen Certificate of Analysis

CoA-2026-A047

ProductSemaglutide

Lot2026-A047

Manufactured2026-05-12

Retest date2028-05-12

AppearanceWhite lyophilized powderpass

Identity (MS)Conformspass

Purity (HPLC)99.4%pass

Water (KF)3.1%pass

Endotoxin (LAL)< 0.5 EU/mgpass

Released by V. Bortnikova, QA21 CFR 210/211

— 06 / Quality Governance

Independent QA. Documented controls. Audit-ready.

Quality reports independently of manufacturing. Every batch record is reviewed, every deviation is investigated, and every customer complaint enters a formal CAPA system.

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FDA-registered

Facility listed in the FDA registry; drug establishment registration current.

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21 CFR 210 / 211

cGMP controls across receiving, synthesis, fill, release, and shipping.

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Independent QA

Quality reports outside of operations; batch release requires QA sign-off.

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Change control

Formal change-control and deviation systems with periodic review.

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CAPA program

Every complaint tracked to root cause with documented corrective action.

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Customer audits

On-site and virtual audits welcomed by appointment.

Spec is the promise.Data is the proof.