Analytical Development and Testing
At RS-LAB, we deliver advanced analytical development and testing services to ensure the integrity, identity, and quality of pharmaceutical products and reference materials. Our approach is grounded in scientific excellence and regulatory compliance, providing precise, reliable data at every stage of development and production.
Whether you’re developing a new drug, certifying a reference standard, or optimizing an existing formulation, we help you confidently determine purity, structure, and composition with the highest level of accuracy.
All analyses are performed using validated methods and state-of-the-art instrumentation, operated by a team of experienced professionals dedicated to supporting your success with quality and precision.
Core elements
- NMR Analysis – Structural confirmation and impurity profiling using ^1H and ^13C Nuclear Magnetic Resonance, ensuring molecular identity and batch consistency.
- IR Analysis – Identification of functional groups and molecular structure through Infrared Spectroscopy, supporting compound verification.
- UV-Vis Analysis – Quantitative and qualitative analysis of chromophoric substances using UV-Visible Spectroscopy, ideal for routine assays and purity checks.
- HPLC Analysis – High-Performance Liquid Chromatography for accurate content uniformity, assay determination, and impurity profiling with high resolution.
- Water Content Determination – Precise moisture analysis using Karl Fischer titration or equivalent validated methods, essential for stability and shelf-life evaluation.
- Residual Solvent Analysis (GC) – Detection and quantification of residual solvents via Gas Chromatography.
- Elemental Analysis – Determination of elemental composition and trace metal content to confirm molecular formulas and detect potential contaminants.
- Certification of Reference Standards – Comprehensive chemical characterization and documentation to certify the identity, purity, and quality of reference materials.
Benefits
- Accelerated Development: Speed up your development timelines by utilizing our expertise in analytical method development and validation—reducing time-to-market while optimizing development costs.
- Regulatory Confidence: Achieve compliance with global regulatory standards through robust method validation and pharmacopoeial testing, supporting smooth product registration and approval processes.
- Assured Quality: Uphold the highest standards of product quality and safety through comprehensive impurity profiling and forced degradation studies, helping you mitigate risks and protect patient health.
- Data-Driven Decisions: Rely on precise, dependable analytical data to guide critical decisions across the product lifecycle—from formulation design to process optimization and quality control strategies.