At Navya Chem Pharma LLC, we provide high-quality reference standards and impurities to support pharmaceutical research, analytical method development, and regulatory compliance. Our expertise covers both simple and complex impurities, from early-stage research quantities to gram-scale requirements, with a strong focus on purity, accuracy, and reproducibility.
We offer both catalog and custom-synthesized reference standards and impurities, including process-related, degradation, and API impurities. Every compound is thoroughly characterized to ensure structural confirmation, purity, and suitability for analytical and regulatory applications.
Our Capabilities Include:
- Custom synthesis of process-related and degradation impurities
- API reference standards and working standards
- Stable isotope-labeled standards for analytical studies
- Isolation and characterization of unknown impurities
- Impurity profiling and structural elucidation
- Milligram to multi-kilogram-scale supply
- Comprehensive analytical characterization (HPLC, GC, LC-MS, NMR)
Why Choose Us?
Navya Chem Pharma is dedicated to delivering highly pure, well-characterized reference standards and impurities that meet global regulatory expectations. With strong technical expertise and reliable manufacturing partnerships, we ensure consistency, traceability, and timely delivery.
Our commitment to quality, flexibility, and precision makes us a trusted partner for pharmaceutical, biotech, and analytical laboratories worldwide.
Why Reference Standards & Impurities Matter
Reference standards and impurities play a critical role in ensuring the safety, efficacy, and quality of pharmaceutical products. They are widely used in:
- Analytical method development and validation
- Stability and forced degradation studies
- Impurity profiling and control strategies
- Regulatory submissions in compliance with ICH guidelines
- Quality control and batch release testing
Accurate and well-characterized materials are essential for reliable analytical results and successful regulatory approvals.
Our Capabilities
1. Impurity Synthesis
- Custom synthesis of process-related, intermediate-related, and degradation impurities
- Support for impurity identification, isolation, and qualification studies
- Handling of complex, low-level, and hard-to-synthesize impurities
2. Reference Standards
- Supply of API reference standards and in-house working standards
- Preparation of characterized standards for method development and validation
- Stable isotope-labeled standards for quantitative analytical studies
3. Impurity Profiling & Characterization
- Structural elucidation using advanced analytical techniques
- Identification of unknown impurities from process and degradation studies
- Development of impurity profiles to support regulatory requirements
4. Scale & Flexibility
- Milligram scale – for analytical method development and early research
- Gram scale – for validation, stability, and regulatory studies
- Flexible production based on project timelines and requirements
5. Analytical Characterization
Every compound undergoes rigorous analytical validation using:
- High-Performance Liquid Chromatography (HPLC/UPLC)
- Gas Chromatography (GC) where applicable
- Mass Spectrometry (LC-MS, GC-MS)
- NMR spectroscopy for structural confirmation
- Certificate of Analysis (CoA) with purity and specification details
6. Regulatory & Documentation Support
- Documentation aligned with ICH guidelines
- Support for DMF filings and regulatory submissions
- Technical data packages including CoA, MSDS, and specifications