Test, document, release.
With research products, quality is not a marketing promise but a question of evidence. We make visible what was tested, by whom, and with what result.
Process
Six stages before release
Every stage creates an entry in the batch file. Whatever is not documented there counts as not having happened.
- 01
Supplier selection
We work only with manufacturers who can evidence process documentation, retention samples and audit readiness. Before a first order we have a sample delivery tested independently.
Audit questionnaire · sample testing · references
- 02
Goods receipt
Every delivery is checked for container condition, labelling, temperature indicator and accompanying documents. Any deviation puts the batch on hold.
Visual check · temperature log · document match
- 03
External analysis
A sample of every batch goes to an independent laboratory. Tested are purity by RP-HPLC, identity by mass spectrometry, water content by Karl Fischer and residual solvents to ICH Q3C.
RP-HPLC · ESI-MS · Karl Fischer · ICH Q3C
- 04
Release
Only once every parameter is within specification is the batch activated in the shop. The certificate is published at the same moment.
Four-eyes principle · batch file · certificate online
- 05
Storage
Stored at −20 °C in monitored freezers with alarms. Temperature curves are recorded without gaps.
−20 °C · data logger · alarm
- 06
Shipping
Temperature-controlled in insulated boxes with pre-cooled gel packs. In hot weather we dispatch only at the start of the week.
Cold chain · tracking · batch card
Specification
What a certificate contains
A certificate of analysis without the method is worthless. That is why ours always state how the measurement was taken – and who took it.
Open a sample certificate- Batch number
- Unambiguous link between delivery, test report and retention sample
- Test date & laboratory
- Name of the testing laboratory and date of the analysis
- Purity
- Percentage with method, column, detection and gradient
- Identity
- Confirmed by mass spectrometry or amino acid analysis
- Water content
- Karl Fischer titration, relevant for weighing in
- Residual solvents
- Assessed to ICH Q3C
What we do not do
No claims we cannot evidence.
We make no statements about effects, applications or health-related properties. Our product texts are limited to physicochemical properties, analysis and handling. Anything else would be neither permissible nor serious.
Retention samples
For every batch we keep a retention sample beyond the stated shelf life, so that any complaint can be traced.
Batch file
Goods receipt, test reports, the release decision and dispatch events sit in one traceable file per batch.
Complaints
Please report anything unusual within 24 hours – ideally with a photo of the temperature indicator and the batch label.
Wichtiger Hinweis