Pharmaceutical Reference Standards & Impurities
Setting the Benchmark in Analytical Excellence
At Rarebio Scientific, we are committed to advancing pharmaceutical quality through the supply of meticulously characterized reference standards and impurity materials. Our solutions are designed to meet the exacting needs of complex therapeutics, including small molecules, peptides, and oligonucleotides.
With deep scientific expertise and state-of-the-art capabilities, we support pharmaceutical companies, CROs, and analytical labs worldwide in achieving precise, reproducible, and compliant analytical results.
We specialize in end-to-end development and supply of reference standards and impurities, with a focus on emerging therapeutic classes such as peptides and oligonucleotides. Each material is thoroughly characterized using validated analytical techniques, ensuring identity, purity, and stability.
Primary Reference Standards:
(Global Pharmaceutical Reference Standards)
- High-purity peptide reference materials, extensively characterized for structural integrity and biological activity
- Custom-synthesized oligonucleotide reference standards tailored to your assay requirements
- Biological reference compounds for complex biologics and biosimilar testing
- Certified Reference Materials (CRMs) supplied with complete CoA, traceability, and documentation
Our comprehensive portfolio of primary pharmaceutical reference standards supports accurate method development, assay calibration, and quality control across diverse drug platforms.
From peptide reference standards and oligonucleotide reference materials to biologics, we ensure traceability, purity, and compliance, helping pharmaceutical and biotech companies meet stringent global regulatory requirements.
Method Design
Tailored analytical methods for complex and novel dosage forms.
Advanced Testing
In-depth structural and molecular analysis using modern tools.
Formulation
Specialized expertise in peptides, liposomes, oligos & more.
Impurity Standards
We offer a diverse range of impurity reference materials designed to identify, quantify, and monitor process- and degradation-related impurities across various drug substances and products.
- Impurity standards for method development, validation and stability study activities for small molecules and peptides.
- Custom-designed impurity markers to support regulatory submissions and QC needs
Frequently Asked Questions
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1What Types Of Primary Reference Standards Do You Offer?
We provide high-purity peptide, oligonucleotide, and biologics reference standards, each extensively characterized for structural integrity and biological activity. All materials are supplied with full traceability, documentation, and a detailed Certificate of Analysis.
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2Can You Supply Custom Reference Standards For Specific Assays?
Yes. Our team specializes in custom-synthesized peptide and oligonucleotide reference standards designed to meet unique assay and analytical requirements, ensuring accuracy and compliance.
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3What Impurity Standards Are Available For Pharmaceutical Testing?
We offer impurity standards for small molecules, peptides, and complex formulations. These include process-related and degradation impurities used in method development, validation, stability studies, and regulatory submissions.
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4How Do You Ensure Quality And Compliance For Your Standards?
All reference and impurity standards undergo rigorous analytical characterization and are accompanied by complete CoA, traceability data, and regulatory-compliant documentation to meet global quality standards.