Peptika.
Quality

Tested before release.

Every Peptika preparation is compounded under EU-GMP Annex 1 Grade A/B cleanroom conditions and tested against the European Pharmacopoeia before it leaves the pharmacy. This page describes exactly what we test and how the certificate ends up in your dashboard.

Test panel

What we check.

Six pharmacopoeial-grade tests run on every batch before release. No test, no release.

  • EP 2.6.1Membrane filtration

    Sterility

    Each filled batch is filtered and incubated against bacterial and fungal growth. No detection — period.

  • EP 2.6.14LAL assay

    Bacterial endotoxins

    Limulus Amebocyte Lysate kinetic assay verifies absence of pyrogenic endotoxins against pharmacopoeial limits.

  • Internal SOPHPLC + MS

    Identity

    High-performance liquid chromatography coupled with mass spectrometry confirms peptide identity against reference standard.

  • Internal SOPHPLC > 98%

    Purity

    Chromatographic purity is verified against reference standard. Specifications threshold: > 98% main peak.

  • EP 2.4.8ICP-MS

    Heavy metals

    Inductively coupled plasma mass spectrometry quantifies lead, mercury, cadmium and arsenic against pharmacopoeial limits.

  • EU-GDP Annex 15Validated 2–8 °C

    Cold-chain integrity

    End-to-end temperature mapping with digital data logger. Excursions outside 2–8 °C trigger reshipment.

Chain of custody

From compounding to your door.

  1. 01
    Active ingredient

    Sourced from EU pharma-grade suppliers

    Active peptide is supplied from EU-licensed pharmaceutical manufacturers operating under their own GMP certification. Certificate of Analysis travels with each shipment.

  2. 02
    Compounding

    EU-GMP Annex 1 Grade A/B

    Compounded under laminar airflow in Grade A zones, surrounded by Grade B background. Environmental monitoring is continuous and recorded against batch records.

  3. 03
    Quality control

    Pharmacopoeial test panel

    Each batch is tested for sterility, endotoxins, identity, purity, heavy metals and content uniformity before release. Out-of-specification results invalidate the batch.

  4. 04
    QP release

    Qualified Person signature

    A Qualified Person under Articles 48 and 51 of Directive 2001/83/EC reviews the complete batch record and signs release. The QP is personally accountable.

  5. 05
    Cold chain

    2–8 °C logistics

    Pharma-validated insulated packaging with phase-change material maintains 2–8 °C for the entire journey. Digital data logger included in each shipment.

  6. 06
    Patient dashboard

    CoA uploaded automatically

    The Certificate of Analysis for your specific batch is uploaded to your patient dashboard the moment it is signed. Batch number on the vial matches the certificate.

Certificate of analysis

Downloadable for every batch.

Your CoA is uploaded to your patient dashboard the moment the Qualified Person signs batch release. The batch number on your vial matches the certificate in your account — full traceability, on demand.

Example · CoA Sample
Batch
PK-2026-BPC-014
Compound
BPC-157 10 mg vial
Filling date
2026-06-12
Sterility (EP 2.6.1)
Pass
Endotoxins (EP 2.6.14)
< 0.5 EU/mg · Pass
Identity (HPLC + MS)
Conforms
Purity (HPLC)
> 99.2%
Heavy metals (EP 2.4.8)
< limit · Pass
QP signature
Released — 2026-06-14

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