Reference Standards & Impurity Synthesis
Nitrosamine Impurity Standards
Nitrosamine impurity is a key component of Milestone Pharma‘s custom impurity services. The nitrosamine-related compounds and reference standards listed on this page support drug development and quality control applications. Our strengths include an integrated multi-platform strategy, deep methodological expertise, and end-to-end project partnerships.
Product List for Nitrosamine
Please contact customer service for a complete list of in-stock reference standards.
Services
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Impurity custom synthesis
We provide custom synthesis solutions ranging from milligram to kilogram scale, covering process-related impurities, degradation products, nitrosamines, and NDSRIs. Each standard is thoroughly characterized and supported by comprehensive documentation.
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Impurity Purification
Using advanced techniques such as Preparative HPLC, Flash Chromatography, Resin and Silica-based Chromatography, we provide specialized purification services that efficiently separate and purify impurities and active ingredients.
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Impurity Structural Characterization
We provide impurity structure confirmation services including: UV, IR, NMR, MS, EA, XRD, TGA, DSC
Scope of Application
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Chemical Synthesis-Related Impurities Customization
Impurities from Active Pharmaceutical Ingredient (API) Synthesis Routes
Intermediates and By-products from Chemical Synthesis Processes
Forced and Accelerated Degradation Impurities from Stability Studies
Genotoxic Impurities (e.g., Nitrosamines, Sulfonate Esters)
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Formulation-Related Specific Impurities Customization
Impurities from Excipients (e.g., Fillers, Binders, Stabilizers)
Extractables and Leachables from Drug Packaging Materials
Chemical Interactions Between Drug and Excipients Leading to Impurities
Impurities from Coating Agents in Solid Dosage Forms
Feature Strengths
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End-to-end impurity and reference standard support across the drug lifecycle
From early development through CMC filing and commercial manufacturing, we support impurity identification, synthesis, qualification/assignment, and reference standard preparation—helping teams build robust impurity control strategies at each stage.
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Quality system, documentation, and traceability built for global compliance
We follow QC laboratory quality system requirements and maintain complete, traceable study records and deliverables (e.g., CoA and characterization data packages), supporting customer audits and regulatory inspections aligned with global submission expectations.
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Efficient purification and confident structural confirmation
With 270+ impurity standards available in stock and multi-technique characterization (e.g., NMR/qNMR and HRMS), we provide high-purity materials and comprehensive data packages to enable accurate identification, quantification, and method development.
FAQ
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Does Milestone Pharma impurity research and reference standard preparation services comply with global drug registration requirements? Can Milestone Pharma support clients through regulatory on-site inspections?
Milestone Pharma strictly follows the requirements of a quality control laboratory system. All experimental processes are complete and traceable, meeting the drug registration requirements of major global regulatory authorities (e.g., NMPA, FDA, EMA, etc.).
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What is the customization process for reference standards? How to obtain the complete list of in-stock impurities?
We will provide a quotation based on your requirements for the purity and quantity of the reference standards. Please contact our customer service to receive the latest product catalog.
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What documentation and characterization data are provided with customized impurities or reference standards?
Each impurity or reference standard can be supplied with a Certificate of Analysis (CoA) and full characterization data, such as HPLC purity, ¹H-NMR, IR, MS/HRMS, and other supporting data based on project requirements.
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Can Milestone Pharma customize nitrosamine impurities or NDSRI reference standards that are not currently in stock?
Yes. We support custom synthesis, purification, and structural confirmation of nitrosamine impurities and NDSRIs. Customers may provide the target structure, CAS number, related API, required quantity, purity, and intended application so that we can evaluate feasibility and provide a quotation.
Discuss My Project
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