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Analytical testing

ALS offer a significant range of analytical services to help drive quality throughout the development processes into routine quality control testing.

ALS provides clients with cost-effective quality assurance paralleled with easily accessible analytical expertise, data-driven insights and current technologies. Furthermore, ALS offers clients access to a global network of collaborative cGMP compliant laboratories.

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ALS: Your partner & collaborator

ALS offers quality focused testing and proactively seeks to form long-term, mutually beneficial relationships. Our clients are accustomed to receiving high quality data, technical support and open communication. The collaborative approach is underpinned by project and client managers, skilled and qualified client service teams, access to technical experts and a management team committed to service delivery. Performing efficiently & ethically, ALS is ready to support the healthcare industries with trustworthy and reliable QC services.

Analytical Testing: Products and Raw Materials

Pharmaceutical products and materials made under current Good Manufacturing Practice (cGMP) require batch or lot release against the approved product specification. Furthermore, importation testing is required for many generic products. Our analytical laboratories possess a wide range of analytical instrumentation and expertise to provide responsive drug product and raw material release testing. Routinely handling a diverse range of sample matrices, including both small and large molecules, leaves ALS well positioned to meet the needs of our clients’ ever expanding product portfolios and diverse product ranges.

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Method Development and Validation

ALS supports the development, validation, verification or transfer of analytical methods ranging from simple identification tests to more complex, stability indicating analysis. Our chemists are adept at developing or working with methods for HPLC, UPLC, GC, GC-MS, Ion Chromatography, ICP-OES, or ICP-MS instruments. Application of Quality by Design (QbD) concepts are entwined throughout ALS-driven development, validation and transfer processes.

Physical & Structural Characterization

Understanding the physical properties of pharmaceutical raw materials is key to successful drug product development and performance. Physical properties such as size/shape, morphology, particle size distribution, flow, density, dissolution profile, bioavailability and melting point enable more efficient formulation and manufacturing process development at the drug product stage. These are all offered by ALS at numerous locations.

Elemental Impurities

Elemental impurities in drug products may arise from several sources; they may be residual catalysts that were added intentionally in synthesis or they may be of unknown origin. As these impurities can be hazardous to patients their levels in excipients, drug substances, drug products and dietary supplements must be controlled and minimized. ALS has some of the world’s leading labs for Elemental analysis per the requirements outlined within ICH Q3D, USP <233> and Ph. Eur. method 2.4.20.

Extractables & Leachables Studies

ALS offers a broad range of specific and non-specific analytical techniques in support of tailored Extractable and Leachables studies. ALS help demonstrate compliance with USP <1663> and <1664> requirements in addition to USP <661> for polymer materials. Modern technologies are underpinned by significant datasets and considerable expertise that allow for quick and efficient study shaping; even for the most complex drug substances and delivery systems.