Quality & compliance
A standard you can defend, not just one you can buy.
Anyone can put a powder in a vial and print a number on a label. The difference is whether the raw data behind that number still exists, and whether it holds up when someone asks.
Principles
Six commitments behind every batch.
Traceable numbers
Every value on a Certificate of Analysis maps back to a raw data file we can produce on request. Nothing is transcribed from a supplier document.
Pharmacopoeial alignment
Impurity designations follow EP, USP, BP, IP and JP nomenclature so the label matches the monograph your method already cites.
ICH-aligned thresholds
Impurity work is scoped against ICH Q3A, Q3B and Q3C reporting, identification and qualification thresholds.
Controlled documentation
Characterisation protocols, batch records and release decisions are version-controlled and retained.
Packed for stability
Light-sensitive, hygroscopic and oxygen-sensitive compounds are packed under inert atmosphere with the handling requirement stated on the label.
Post-supply support
If a regulator queries an impurity we supplied, we provide the supporting data and, where needed, a technical narrative for your response.
Release protocol
What has to be true before a batch leaves.
A batch is released only when all five stages below are complete and reviewed. If any one of them is inconclusive, the material is reworked or rejected — it does not ship with a caveat.
Request a sample CoA-
01
Identity
Structure confirmed by ¹H NMR and mass spectrometry, supported by ¹³C, 2D experiments or IR where the assignment needs it.
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02
Purity
Chromatographic purity determined by HPLC, UPLC or GC against a method documented in the release record.
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03
Counter-ions & volatiles
Water content, residual solvents and inorganic residue quantified so they can be deducted from the assay.
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04
Assigned potency
Potency assigned by mass balance from the measured purity and the quantified impurities, not by area normalisation alone.
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05
Re-test period
A re-test date set from stability behaviour and storage conditions, and printed on the certificate.
The dossier
Everything that travels with the compound.
Certificate of Analysis
Assigned potency, identity confirmation, chromatographic purity, water content and re-test date.
NMR Spectra
¹H and, where structurally required, ¹³C and 2D spectra with full peak assignment.
Mass Spectrum
LC-MS or HRMS confirming molecular ion and, where relevant, fragmentation pattern.
HPLC / GC Purity
Chromatographic purity trace with the method conditions used to generate it.
IR Spectrum
Functional group confirmation supporting the assigned structure.
Safety Data Sheet
GHS-format MSDS covering handling, storage and transport classification.
Nomenclature
Named the way your monograph names it.
Impurity letters differ between pharmacopoeias, and getting them wrong costs a review cycle. Our catalogue uses the designation the source monograph uses, and we will confirm the equivalence before you order.
EP
European Pharmacopoeia
USP
United States Pharmacopeia
BP
British Pharmacopoeia
IP
Indian Pharmacopoeia
JP
Japanese Pharmacopoeia
ICH
Q3A / Q3B / Q3C Guidance
Important use restriction
All compounds supplied by Synthesis Analytics are intended for analytical, research and quality-control use only.
They are not intended for human or veterinary use, and must not be administered to humans or animals or used as, or in, a finished medicinal product.
Many catalogue items are impurities, degradation products or process intermediates and should be treated as potentially hazardous. Handle in accordance with the supplied safety data sheet and your own institutional risk assessment.
Need a specific quality statement, questionnaire response or supplier qualification document? Ask — we would rather complete it properly than have you infer it from a website.
Contact quality assurance