APIs and Drug Substances
We perform comprehensive testing of active pharmaceutical ingredients (APIs) and drug substances to verify identity, purity, potency, and chemical characteristics. Our rigorous analytical approaches ensure batch-to-batch consistency, compliance with pharmacopeial standards, and readiness for downstream formulation and clinical use.

Drug Products
Our team conducts in-depth analysis of finished drug products, assessing formulation integrity, content uniformity, and overall product quality. These studies support product release, quality assurance, and lifecycle monitoring, helping ensure that products consistently meet safety and efficacy standards.

Elemental Impurity Testing
Using advanced techniques such as ICP-based analysis, we detect and quantify trace elemental impurities, ensuring compliance with ICH, USP, and other global regulatory guidelines. These assessments mitigate safety risks and are critical for regulatory approval.

Genotoxic Impurity Analysis
We provide specialized testing for genotoxic impurities at trace levels. These analyses are essential to evaluate potential mutagenic or carcinogenic risks, ensuring product safety and meeting global regulatory expectations.

Dissolution Testing
Dissolution studies are essential to assess drug release profiles and ensure consistent bioavailability. Our laboratories conduct controlled dissolution testing to support formulation development, regulatory submissions, and quality control throughout the product lifecycle.

Stability Studies
We perform accelerated and long-term stability studies under controlled environmental conditions to determine shelf life, packaging compatibility, and long-term product integrity. Data generated from these studies supports regulatory filings, product lifecycle management, and quality assurance.

Solid-State Characterization
Our solid-state analysis services identify and characterize polymorphs, crystalline forms, and other physical properties that can impact drug solubility, stability, and performance. This information helps optimize formulation, manufacturing, and storage strategies.

Method Development & Validation

Our scientists develop and validate robust, regulatory-compliant analytical methods tailored to the specific needs of each product. These validated methods ensure reliable, reproducible, and globally accepted testing results, supporting both development and routine quality control.

Regulatory Documentation Support
Keysight Chemtech provides comprehensive analytical documentation to support regulatory submissions, including method validation reports, analytical summaries, impurity profiles, and stability reports. All documentation is aligned with global standards and ready for submission to FDA, EMA, ICH, and other regulatory authorities.

Commitment to Quality and Compliance

At Keysight Chemtech, scientific integrity and quality are central to every analytical program. Our laboratories adhere to internationally recognized guidelines and follow rigorous quality control procedures, ensuring accurate, reliable, and reproducible data.

By integrating advanced technology, experienced scientific teams, and regulatory expertise, we help clients maintain product safety, efficacy, and consistency while meeting the expectations of global regulatory authorities.