From batch to published certificate
A certificate is published here only after an outside laboratory has tested the batch and the overall result is a pass. The figures on this page come from the published certificates.
Release
How a certificate is released
01BATCH
Batch produced
The batch gets its batch number, manufacturing date and expiry date.
02SAMPLE
Sample sent for testing
A sample from the batch goes to the outside testing laboratory.
03TESTS
Tests run
The laboratory runs each test listed on the certificate and compares the result with its specification.
04REPORT
Certificate issued
The laboratory issues a Certificate of Analysis with a report number, each result and the issue date.
05PUBLISHED
Published if it passes
The certificate is published only when its overall result is a pass. Pending and failed certificates are not shown.
06UNIT CODE
Opened by unit code
Each unit code issued for the batch opens the batch record and its certificate.
Testing laboratory
The laboratory named on the certificates
Name and accreditation statement are copied from the published certificates. The laboratory is an outside laboratory and is not part of Synedica Laboratories, although the names are similar.
- Laboratory
- Synedica Analytical Laboratories
- Accreditation statement, as printed
ISO/IEC 17025 aligned methods
- Certificates naming it
- 11
- Issue dates
- January 2026 to August 2026
Tests and methods
What the published certificates test
15 different tests appear on the 11 published certificates. Names, methods and specifications are shown as printed on the certificates, in English.
Appearance
MethodVisual inspection, Ph. Eur. 2.2.1
SpecificationClear, colourless solution, free from visible particles
On certificates11 of 11
Identity
MethodESI-MS, ≤ 5 ppm
SpecificationConfirmed [M+5H]⁵⁺ = 947.3
On certificates11 of 11
Assay (content)
MethodRP-HPLC-UV, C18, 220 nm
Specification95.0 – 105.0% of label claim
On certificates11 of 11
Purity
MethodRP-HPLC-UV, C18, 220 nm
Specification≥ 98.0%
On certificates11 of 11
Related substances
MethodRP-HPLC-UV, area normalisation
Specification≤ 2.0% total
On certificates11 of 11
pH
MethodPotentiometry, Ph. Eur. 2.2.3
Specification7.0 – 8.0
On certificates11 of 11
Osmolality
MethodPh. Eur. 2.2.35
Specification270 – 330 mOsm/kg
On certificates11 of 11
Preservative content
MethodRP-HPLC-UV (m-cresol)
Specification85.0 – 115.0% of label claim
On certificates11 of 11
Extractable volume
MethodPh. Eur. 2.9.17
SpecificationDiffers by formulation
On certificates11 of 11
Container closure integrity
MethodDye ingress, ASTM F1929
SpecificationNo ingress
On certificates11 of 11
Visible particles
MethodPh. Eur. 2.9.20
SpecificationPractically free from visible particles
On certificates11 of 11
Particulate matter (sub-visible)
MethodLight obscuration, Ph. Eur. 2.9.19
SpecificationMeets Ph. Eur. limits for parenteral use
On certificates11 of 11
Sterility
MethodMembrane filtration, Ph. Eur. 2.6.1
SpecificationNo growth at 14 days
On certificates11 of 11
Bacterial endotoxins
MethodLAL kinetic chromogenic, Ph. Eur. 2.6.14
Specification< 10.0 EU/mL
On certificates11 of 11
Elemental impurities
MethodICP-MS, ICH Q3D / Ph. Eur. 2.4.20
SpecificationMeets ICH Q3D parenteral limits
On certificates11 of 11
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