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Synedica Laboratories

External laboratory testing

Certificates of Analysis

Certificates of Analysis for Synedica batches, by report number and batch.

Product

11 certificates

From batch sample to published certificate

Each certificate covers one production batch.

  1. 01

    Sample logged

    A sample from the batch is logged under an accession number, which becomes the report number.

  2. 02

    Purity by HPLC-UV

    Reversed-phase HPLC on a C18 column at 220 nm separates the active from related substances and gives the assayed purity.

  3. 03

    Identity by ESI-MS

    Electrospray mass spectrometry confirms the molecular mass of the active, within 5 ppm.

  4. 04

    Listed tests

    The remaining tests on the certificate are run against the specification printed beside each one.

  5. 05

    Release

    Quality Assurance authorises the certificate electronically and it is published here, under its report number.

All analysis performed under documented analytical methods aligned to European Pharmacopoeia (Ph. Eur.) reference procedures: HPLC-UV (C18, 220 nm) for purity and related substances; ESI-MS (≤ 5 ppm) for identity confirmation.

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A certificate covers a batch. To check one unit, enter its unit code.

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