Laboratory Services

ICP-MS Capabilities

Analytical Services
Extractables & Leachables Testing
Laboratory Services
Specialty Capabilities

Advanced ICP-MS Capabilities for Comprehensive Elemental Impurities Testing

At Alcami, our Inductively Coupled Plasma Mass Spectrometry (ICP-MS) capabilities are designed to meet the stringent demands of modern pharmaceutical and biotechnological applications. Our advanced ICP-MS services include a wide range of analytical capabilities, such as catalyst control, assay determination, organometallic compound analysis, and cleaning verification methods, all complemented by comprehensive elemental impurities testing for both raw materials and finished products.

Expertise in Elemental Impurities Testing

The latest elemental impurities regulations emphasize the critical need to control all sources of elemental impurities in drug products, affecting both new and existing commercial products intended for human use. Compliance with these regulations requires an approach that is not only efficient and cost-effective but also accepted by regulatory agencies. At Alcami, we bring a wealth of experience and agility to expertly manage your ICP-MS testing needs, ensuring your products meet all necessary regulatory standards.

Comprehensive ICP-MS Capabilities

Limit Testing: Ensuring compliance with specified impurity thresholds.

Catalyst Control: Monitoring and controlling catalysts used in pharmaceutical processes.

Extractables & Leachables: Identifying potential contaminants from packaging and manufacturing systems.

Organometallics: Analyzing complex organometallic compounds in drug formulations.

Full Quantitation Analysis: Providing accurate quantification of trace elements.

Assays: Conducting comprehensive assays for precise impurity profiling.

Improved Testing Accuracy & Speed: Utilizing cutting-edge technology to enhance testing efficiency and precision.

Initial Elemental Impurity Assessment: Conducting preliminary assessments of elemental impurities in materials.

Risk Assessments: Offering detailed risk assessments on current materials and providing comprehensive reports for regulatory filings.

Unknown Metal Impurities: Analyzing samples with unidentified metal impurities to determine their composition.

Standalone Elemental Impurity Methods: Developing and validating methods for standalone impurity testing.

Validated Methods for Release Testing: Ensuring that all elemental impurity testing methods are fully validated and ready for product release.

Why Choose Alcami for ICP-MS Testing?

Our state-of-the-art ICP-MS technology, combined with our team’s expertise, allows us to deliver accurate and timely results that meet the highest standards of quality and compliance. Whether you need routine testing or specialized analysis, Alcami’s ICP-MS capabilities are here to support your drug development and manufacturing processes with precision and reliability.

Related Topics
Leveraging Inductively Coupled Plasma Mass Spectrometry To Its Full Potential
Contact Alcami
Summary

Alcami offers advanced ICP-MS capabilities to meet the stringent requirements of elemental impurities testing in pharmaceutical products. Our services include catalyst control, organometallic analysis, and comprehensive risk assessments, all designed to ensure compliance with regulatory standards. With state-of-the-art technology and expert knowledge, Alcami provides precise and efficient ICP-MS testing to support drug development and manufacturing.

Related Topics
Leveraging Inductively Coupled Plasma Mass Spectrometry To Its Full Potential
Contact Alcami
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