Impurities & Standards
At Alpine Pharma, we are a trusted partner in delivering specialized solutions for the synthesis, characterization, and qualification of impurities and working standards. Our services are designed to support pharmaceutical R&D, regulatory submissions, and quality control with
precision, compliance, and scientific rigor.
We provide end-to-end services, from custom synthesis to the delivery
of fully characterized, high-quality reference materials, all aligned with
global regulatory standards.
Impurity Synthesis
(Process-Related / Degradation / Genotoxic)
We offer custom synthesis of known, unknown, and novel impurities—including process-related, degradation, and genotoxic impurities—at milligram to gram scale.
We offer custom synthesis of known, unknown, and novel impurities—including process-related, degradation, and genotoxic impurities—at milligram to gram scale.
Each compound is thoroughly
characterized using advanced techniques such as:
- NMR (Nuclear Magnetic Resonance)
- MS (Mass Spectrometry)
- IR (Infrared Spectroscopy)
- UV Spectroscopy
- Chromatographic methods (HPLC, GC)
Working Standard Preparation & Qualification
We prepare and qualify Primary Standards & Working Standards (WS) against traceable pharmacopeia working standards with comprehensive characterization, including:
Purity profiling
Chromatographic behavior
Stability evaluation
All processes comply with pharmacopeial standards or are customized to
meet specific client requirements.
Impurity Profiling & Characterization
Our impurity profiling services align with ICH Q3A/Q3B guidelines, supporting regulatory submissions with:
- Impurity identification and structural elucidation
- Quality risk assessments
- Threshold determination and reporting strategies
Comprehensive Analytical Documentation
Each project is delivered with a full analytical data package, including:
Certificate of Analysis (CoA)
Method of synthesis
Characterization & validation data
Stability information
This documentation is tailored for both regulatory filings and internal reference use.
Regulatory Support
We provide complete support for impurity justification and reporting in CTD submissions, including qualification strategies that meet global
regulatory requirements.
By integrating synthetic chemistry expertise with robust analytical capabilities and deep regulatory insight, Alpine Pharma delivers reliable, reproducible, and fully compliant reference materials. Our solutions are designed to accelerate development timelines while ensuring regulatory confidence and analytical precision.