At Navya Chem Pharma LLC, we specialize in the development, characterization, and supply of high-quality reference standards and impurities to support pharmaceutical research, development, and regulatory submissions. These materials play a critical role in analytical method validation, quality control, stability studies, and regulatory compliance.
Our expert chemists design, synthesize, isolate, and fully characterize impurities and reference standards, ensuring they meet stringent regulatory guidelines (ICH, USP, EP, JP) and industry requirements.
Our Capabilities Include:
- Synthesis and isolation of process-related and degradation impurities
- Supply of primary and secondary reference standards
- Structural elucidation and analytical characterization (NMR, MS, HPLC, IR)
- Stable isotope-labeled compounds for advanced studies
- Custom synthesis to meet client-specific requirements
Why Choose Us?
We provide accurately characterized, highly pure, and well-documented reference standards and impurities to pharmaceutical and biotech companies worldwide. With our scientific expertise, regulatory knowledge, and state-of-the-art facilities, Navya Chem Pharma ensures that your projects progress seamlessly and meet global compliance standards.
Importance of Reference Standards & Impurities
- Reference Standards: Pure, well-characterized compounds used as benchmarks in analytical testing.
- Impurities: Process-related or degradation compounds that need to be identified, synthesized, and studied to meet global regulatory requirements.
Proper availability and documentation of these compounds ensures:
- Regulatory compliance with ICH, USFDA, EMA, and other authorities
- Accurate analytical testing & method validation
- Product quality, purity, and safety assurance
- Successful submission of DMFs and dossiers
Partner With Navya Chem Pharma
By leveraging cutting-edge technology, regulatory knowledge, and deep scientific expertise, Navya Chem Pharma ensures accurate, reliable, and timely supply of reference standards and impurities. We are committed to helping our clients achieve regulatory success, uncompromised product quality, and patient safety worldwide.
Applications of Our Standards & Impurities
- Analytical method development and validation
- Quality control (QC) & release testing
- Stability studies & forced degradation analysis
- Pharmacopoeia compliance (USP, EP, JP, BP)
- Regulatory filings (DMF, ANDA, NDA)