Pharmaceutical Analytical Impurity Reference Standards
High-Quality Impurity Standards for Pharmaceutical Analysis
The reliable identification, quantification, and control of impurities are central components of pharmaceutical development and quality control. Eurofins offers a comprehensive portfolio of Pharmaceutical Analytical Impurity Reference Standards to support method development, method validation, stability studies, and regulatory requirements according to ICH guidelines.
Our analytical impurity standards support pharmaceutical companies, CDMOs, CROs, contract laboratories, and research institutions in ensuring product quality, patient safety, and regulatory compliance.
Discover our selection of Impurity Reference Standards for active pharmaceutical ingredients, drug products, and pharmaceutical raw materials.
What are Pharmaceutical Analytical Impurity Reference Standards?
Impurity Reference Standards are highly characterized reference materials used for the detection, identification, and quantification of impurities in active pharmaceutical ingredients and finished drug products.
They serve as analytical references for:
- Impurity profiling
- Method development
- Method validation
- Release testing
- Stability studies
- Degradation product analysis
- Regulatory submissions
- GMP-compliant quality control
The use of appropriate reference standards enables a precise assessment of product-related and process-related impurities.
Types of Pharmaceutical Impurities
Process-Related Impurities
These impurities arise during the synthesis or manufacturing of an active pharmaceutical ingredient.
Typical examples:
- Reaction by-products
- Intermediates
- Starting materials
- Catalyst residues
- Reagent residues
Degradation Products
Degradation products result from physical or chemical changes during storage, transport, or use.
Key influencing factors:
- Temperature
- Light
- Moisture
- Oxidation
- pH value
Genotoxic Impurities
Genotoxic impurities (GTIs) must be monitored particularly strictly due to their potential risk to patient safety.
Our standards support:
- Risk assessments according to ICH M7
- Sensitive detection methods
- LC-MS/MS methods
- Regulatory documentation
Nitrosamine Standards
Nitrosamines have been under increased regulatory scrutiny for several years.
We offer reference standards for numerous relevant nitrosamine compounds to support:
- Nitrosamine screenings
- Method validations
- Batch releases
- Stability studies
Our Portfolio of Impurity Standards
API Impurity Standards
Reference standards for active pharmaceutical ingredient-related impurities (Related Substances) to support pharmacopoeial and non-pharmacopoeial analyses.
Known Impurity Standards
Specifically characterized standards for known impurities for quantitative determination and identification.
Degradation Product Standards
Reference materials for degradation products within the scope of stability studies and forced degradation programs.
Metabolite Standards
Standards for metabolites within the scope of pharmaceutical research, bioanalysis, and drug development.
Custom Synthesis Standards
Individually synthesized reference substances for specific development and research projects.
Areas of Application
Our Pharmaceutical Analytical Impurity Standards support:
- HPLC analyses
- UHPLC methods
- GC analyses
- LC-MS/MS
- Stability studies
- Method development
- Method validation
- Release analytics
- Quality control
- Pharmaceutical development
Why Eurofins?
Extensive Availability
Access to thousands of impurity standards for active pharmaceutical ingredients and drug products.
Fast Procurement
Efficient procurement processes and reliable supply chains for standard products and custom syntheses.
Analytical Expertise
In-depth know-how in pharmaceutical analysis, regulatory requirements, and impurity management.
Support for Regulatory Requirements
Suitable for supporting tests according to:
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