Reference Standards for Pharmaceutical Analysis
Precise Analysis. Reliable Results. Regulatory Certainty.
Reference standards are indispensable tools for pharmaceutical analysis. They enable the precise identification, quantification, and quality assessment of active pharmaceutical ingredients (APIs), impurities, metabolites, and other pharmaceutically relevant substances. Eurofins offers an extensive portfolio of reference standards for research, development, quality control, and regulatory applications.
Whether it's method development, validation, release testing, or stability studies: our reference standards support you in complying with the highest scientific and regulatory requirements.
Discover high-quality reference standards for pharmaceutical analysis from a reliable source.
What are Reference Standards?
Reference standards are highly characterized substances with known properties and defined purity. They serve as a benchmark in analytical procedures and ensure reproducible and reliable results.
They are used in numerous applications in the pharmaceutical industry, including:
- Identity tests
- Assays
- Method development
- Method validation
- Stability studies
- Impurity analysis
- Batch releases
- Regulatory approval processes
Our Portfolio for Pharmaceutical Analysis
Pharmacopoeial Reference Standards
Official reference standards from leading pharmacopoeias for compendial tests and regulatory compliance.
Active Pharmaceutical Ingredient (API) Standards
Reference materials for the identification and quantification of active pharmaceutical ingredients in raw materials and finished drug products.
Impurity Standards
Standards for known impurities, degradation products, nitrosamines, and genotoxic compounds.
Metabolite Standards
Reference substances for bioanalysis, drug development, and pharmacokinetics.
Extractables & Leachables Standards
Standards for investigating potentially migrating substances from packaging, single-use systems, and product-contact materials.
Areas of Application
Our reference standards support analytical procedures such as:
- HPLC
- UHPLC
- LC-MS/MS
- GC
- GC-MS
- ICP-MS
- UV/VIS Spectroscopy
Typical areas of application:
- Pharmaceutical Quality Control
- Research & Development
- GMP Laboratories
- Stability Programs
- Release Analysis
- Contract Analysis (CRO/CDMO)
- Biopharmaceutical Development
Why Eurofins?
Broad Product Range
Access to a large selection of pharmaceutical reference standards for various analytical applications.
Regulatory Expertise
Support for requirements according to:
- ICH Guidelines
- USP
- European Pharmacopoeia (Ph. Eur.)
- British Pharmacopoeia
- GMP Requirements
Fast Availability
Efficient procurement processes and reliable delivery for routine analyses and development projects.
Competent Consulting
Our experts support you in selecting suitable reference standards for your analytical requirements.
Frequently Asked Questions
Why are reference standards important for pharmaceutical analysis?
Reference standards ensure the accuracy, reproducibility, and comparability of analytical results and are essential for regulatory compliant testing.
What types of reference standards are available?
Key categories include pharmacopoeial standards, API standards, impurity standards, metabolite standards, and extractables & leachables standards.
Are reference standards used for GMP applications?
Yes. Reference standards are a central component of GMP-compliant quality control and release testing.
Find the Right Reference Standard
Eurofins supports pharmaceutical companies, contract laboratories, and research institutions with high-quality reference standards for the entire spectrum of pharmaceutical analyses.
Your Advantages at a Glance
✅ Comprehensive portfolio of reference standards
✅ Solutions for HPLC, LC-MS/MS, and GC-MS
✅ Support for regulatory requirements
✅ Fast delivery and reliable availability
✅ Competent pharmaceutical consulting
Discover reference standards for pharmaceutical analysis now
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