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Norven Medical GmbH · Quality

Quality Standards

Pharmaceutical-grade purity at every stage of production.

01 — Quality Promise

Quality is embedded, not appended.

Quality at Norven Medical is not a final checkpoint — it is embedded throughout the entire production process. From raw material procurement to final lyophilisation, every step is governed by written SOPs (Standard Operating Procedures) and verified by our quality assurance team.

02 — Raw Material Control

Certified European supply chain.

All amino acids, reagents, and solvents used in synthesis are sourced exclusively from certified European suppliers. Each incoming material is tested for identity and purity before entering production.

03 — In-Process Controls

Verified at every critical stage.

During synthesis, samples are taken at critical stages and analysed by HPLC and mass spectrometry to confirm correct sequence, molecular weight, and intermediate purity. Any batch that does not meet specifications is rejected and destroyed.

04 — Final Release Testing

The full release panel.

Before a batch is released for shipment, it undergoes a full panel of release tests:

TestSpecification
HPLC Purity≥ 99.0%
Mass SpectrometryConfirmed molecular identity
Endotoxin TestingLAL method, < 1 EU/mg
Residual SolventsWithin ICH Q3C limits
Moisture ContentKarl Fischer titration
Visual InspectionClarity, colour, absence of particulates

05 — Traceability

Every batch, fully traceable.

Every compound is assigned a unique batch code (format: NVM + 6 digits) that links to its full production and testing record. Customers can verify their batch at norvenmedical.com/track.