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ISO 17025

Accredited

Analytical Services

Precision Analysis You Can Trust

Our comprehensive analytical capabilities span the entire spectrum of pharmaceutical characterization. With state-of-the-art instrumentation and highly trained scientists, we deliver reliable, reproducible results that meet the most stringent regulatory requirements. Whether you need routine quality control or advanced structural elucidation, ChemContract provides the analytical expertise your program requires.

Method Development & Validation

Custom analytical methods developed and validated to ICH Q2(R1) standards for maximum confidence in your data.

Structural Characterization

Advanced techniques including NMR, MS, and X-ray diffraction to fully elucidate molecular structure and properties.

Quality Control & Stability

Comprehensive testing programs ensuring product quality throughout development and commercial lifecycle.

Equipment & Capabilities

Advanced Analytical Instrumentation

Industry-leading equipment enabling rapid, accurate analysis across diverse molecular properties and compound classes.

NMR Spectroscopy

1D and 2D NMR analysis for structure elucidation, stereochemistry assignment, and dynamic studies.

Mass Spectrometry

LC-MS/MS and GC-MS platforms for compound identification, purity analysis, and metabolite detection.

HPLC & UPLC

High-performance liquid chromatography for purity assessment, impurity profiling, and related substances analysis.

X-Ray Diffraction

Single crystal and powder XRD for polymorphism screening and crystal structure determination.

Thermal Analysis

DSC and TGA for melting point determination, thermal stability assessment, and decomposition profiling.

Elemental Analysis

CHN analysis, trace metals detection, and elemental composition determination via ICP-OES.

Routine Testing

•Identity testing
•Assay & purity analysis
•Residual solvents
•Heavy metals & elemental impurities
•Water content (Karl Fischer)
•Particle size distribution

Advanced Analysis

•Polymorph & crystal form screening
•Salt & co-crystal screening
•Forced degradation studies
•Extractables & leachables testing
•Genotoxic impurities (Ames testing)
•Chiral analysis & enantiomer purity

Regulatory Compliance

Quality Standards & Certifications

All analyses meet or exceed the most stringent global pharmaceutical and analytical standards.

FDA

FDA Compliance

Methods and practices align with FDA guidance documents and 21 CFR requirements for pharmaceutical manufacturing.

EMA

EMA Guidelines

European Medicine Agency guidelines compliance ensuring acceptance across EU and international markets.

ICH

ICH Q2(R1)

International Council for Harmonisation validation guidance ensuring data integrity and method robustness.

USP

USP/EP/JP

Pharmacopeial standards from United States, European, and Japanese pharmacopeias integrated into testing protocols.

cGMP

cGMP Certified

Current Good Manufacturing Practice compliance ensuring quality systems meet pharmaceutical manufacturing standards.

ISO

ISO 17025 Accredited

International standard for competence of testing and calibration laboratories with third-party verification.

Questions & Answers

Analytical Services FAQ

Common questions about our analytical capabilities and testing services.

What is the typical turnaround time for analytical testing? +

Turnaround times vary depending on the complexity and scope of analysis. Routine testing typically requires 5-10 business days, while advanced characterization studies may take 2-4 weeks. We provide expedited services for urgent projects. Contact our team for specific timelines for your analysis.

Can you validate analytical methods for our internal use? +

Yes, we specialize in method development and validation services. Our team can work with you to develop custom analytical methods tailored to your specific compound properties and regulatory requirements. All validations follow ICH Q2(R1) guidelines for maximum compliance and acceptance by regulatory authorities.

What sample size is required for comprehensive analytical testing? +

Sample requirements depend on the analytical techniques requested. For typical pharmaceutical compounds, we recommend 100-500 mg for comprehensive analysis including NMR, MS, and HPLC characterization. We can work with smaller quantities for preliminary analysis. Our scientists will advise on optimal sample sizes during project planning.

Are your analytical reports suitable for regulatory submissions? +

Absolutely. Our comprehensive analytical reports are formatted for direct inclusion in IND, CTA, NDA, and ANDA submissions. Reports include detailed methodology, quality control data, chromatograms, spectra, and full compliance documentation with relevant pharmacopeial and ICH standards, supporting regulatory acceptance worldwide.

Comprehensive Analytical Services