Pharmaceutical Reference Standards
Pharmaceutical Reference Standards & Custom Synthesis
At Epichem, we specialise in the supply and custom synthesis of pharmaceutical reference materials to support research, development, and regulatory compliance across the life sciences sector. From pharmacopeial standards to hard-to-source impurities, our team delivers high-quality reference compounds backed by expert service and reliable turnaround.
As a trusted reference standards manufacturer, we partner with global clients across pharma, biotech, and academia to provide both catalogue and custom materials—tailored to your exact needs.
Our reference materials are prepared to maximum possible purity and where a pharmacopoeial standard exists, are supplied as bulk, fully characterised working standards equivalent to BP / EP and USP grades.
Our Australian reference materials are supplied with a comprehensive data package that includes all of the relevant analytical data, spectra and conditions to establish identity and purity.
We routinely characterise our products with 1H NMR, LC/MS, CHN elemental analysis and IR for identity. We establish purity with HPLC, Karl-Fischer water content, ash content and residual solvent content. In specific cases we also use X-ray crystallography to determine relative stereochemistry, chiral HPLC for enantiomeric purity and, where required, Quantitative 1H NMR.
See here for an example of the Product Information Sheet we provide with our reference materials.
Click here to browse our Pharmaceutical Reference Material catalogue products
🔬 What Are Reference Standards—and Why Do They Matter?
Reference standards are well-characterised, high-purity compounds used as benchmarks in analytical testing. Whether it’s for identity confirmation, impurity profiling, or method validation, the accuracy of your reference material is critical to ensuring product quality and meeting regulatory expectations.
Our reference standards are used in:
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Analytical method development and validation
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Stability studies
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Impurity and degradant profiling
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Regulatory submissions (e.g. FDA, EMA, TGA)
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Batch release and routine QC testing
⚗️ Custom Synthesis of Pharmacopeial Reference Standards
Can’t find what you need in a catalogue? We’ve got you covered.
Epichem offers a full custom synthesis service for pharmacopeial and non-pharmacopeial reference standards, with a track record of delivering complex molecules at high purity. Our synthetic chemists work with you to design and deliver reference materials that are fully characterised and fit-for-purpose.
Our service includes:
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Route design and feasibility review
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Custom synthesis of your target compound
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Full analytical characterisation (HPLC, NMR, MS, IR, Ash, water (KF), residual solvent (1H NMR))
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Detailed Certificate of Analysis (CoA)
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Scalable production, from milligrams to grams
We work flexibly and efficiently—whether you're sourcing a known impurity or a novel research standard.
🧪 What We Offer
We supply a broad range of pharmaceutical reference research standards, including:
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Pharmacopeial and regulatory-grade reference substances
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API impurities and degradation products
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Process intermediates and metabolites
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Isotopically labelled compounds
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Custom-designed materials for emerging therapies
🌍 Why Partner with Epichem?
Epichem is more than a reference standards supplier. We're a collaborative partner, with scientific depth and a commitment to quality that extends beyond the compound itself.
Why clients choose us:
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Experienced, PhD-led chemistry team
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Responsive and transparent communication
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Full traceability and documentation
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Worldwide delivery and export compliance
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Competitive lead times and flexible batch sizes
"They provide great service, not just a great product. Epichem stands behind their product and readily shares its expertise."
— Healthcare Products Manufacturer, United States
Our clients return to us not only for the chemistry—but because they know we care about the science behind it.
💬 Frequently Asked Questions
Do you offer custom synthesis of reference standards?
Yes—we routinely synthesise pharmacopeial and non-pharmacopeial reference materials tailored to your specifications.
What documentation is included?
All materials are supplied with a CoA and comprehensive analytical data package. Standard analysis package includes: HNMR, HPLC, LCMS, FTIR, MP, Water (KF), Ash, and Elemental microanalysis (CHN/S). Additional characterisation is available on request.
How long does custom synthesis take?
Lead times typically range from 2–6 weeks, depending on complexity. We’ll always give you a clear estimate up front.
Can Epichem ship internationally?
Absolutely. We have extensive experience in global logistics and can provide all necessary documentation to ensure smooth delivery.
📩 Enquire Now
If you need a specific reference standard or want to discuss a custom synthesis project, we’re ready to help. Contact our team for a quote or a confidential consultation.
Get in Touch or email sales@epichem.com
