Pharmacetical Analytical Testing
At BIO-LEO Analytical Labs India Pvt. Ltd., we specialize in Pharmaceutical Analytical Testing designed to ensure the quality, safety, and regulatory compliance of pharmaceutical products. Our advanced laboratory infrastructure, combined with validated testing methods, allows us to deliver accurate, reliable, and reproducible results for raw materials, intermediates, and finished formulations.
Raw Material & Excipient Analysis
We conduct comprehensive testing of raw materials and excipients to ensure identity, purity, safety, and compliance with pharmacopeial standards. Our analyses support material approval before use in manufacturing.
Method Development, Validation, Verification & Release Testing
Our expert team develops robust analytical methods tailored to product requirements. We perform complete method validation and verification as per ICH guidelines to ensure accurate and reproducible results.
Impurity Testing
Using advanced instruments, we identify, quantify, and profile impurities in APIs and formulations, ensuring product quality and regulatory compliance.
Assay / Purity
We offer precise assay and purity determination for APIs, excipients, intermediates, and finished products using chromatographic and spectroscopic techniques.
Impurity Characterization
Our team specializes in identifying unknown impurities and degradation products using advanced analytical tools, ensuring complete impurity profiling.
Physical Characterization
We assess key physical properties such as appearance, pH, viscosity, density, particle size, melting point, and other parameters critical for product performance and consistency.
In-Process & R&D Sample Testing
We provide analytical support for manufacturing and R&D activities with quick testing of process samples, trial batches, prototype formulations, and developmental studies.
Finished Products & Intermediates Testing
Comprehensive testing of finished dosage forms and intermediates to verify quality, potency, and compliance with regulatory specifications.
Chemical Analysis
Accurate analysis of chemical substances, active ingredients, excipients, and contaminants using validated analytical techniques such as HPLC, GC, UV, FTIR, and more.
Dissolution Studies
We perform dissolution profiling for immediate-release, sustained-release, and modified-release formulations, supporting bioavailability and stability assessments.
Our Expertise
We provide a comprehensive suite of analytical services, including impurity profiling, assay and purity determination, dissolution studies, stability testing, method development, validation, verification, and packaging material evaluation. Using advanced techniques such as HPLC, GC, GC-HS, UV, IR, ATR, potentiometry, and particle size analysis, we support both routine quality control and complex research and development requirements.
Pharmaceutical Analytical Testing
Our Pharmaceutical Analytical Testing services play a crucial role in helping manufacturers meet global regulatory expectations, maintain batch-to-batch consistency, and ensure the overall quality and performance of their products.