Pharmaceutical Product Testing
Maxxam offers heavy and other trace metals analysis in pharmaceutical drug products and dietary supplements of various types ranging from proteins and cytotoxic compounds to peptides and oligomers. More
Antifoam agents, divalent metal cation and EDTA impurities are often associated with the manufacturing and formulation process of biologics. Maxxam has developed a number of analytical procedures required for in-process monitoring as well as bulk and final product release testing. More
Method Development and Validation
Maxxam offers comprehensive method development and validation services for regulatory and non-regulatory investigational studies. Our validation protocols follow industry standards such as the ICH, USP or the FDA’s Guidance on Bio-analytical Methods Validation as required. We also customize our protocols to accommodate client’s individual needs and expectations.
Our customers rely on Maxxam to provide a variety of analytical testing services to identify, qualify and report product- and process-related impurities. These services include: Active Pharmaceutical Ingredients (APIs), Raw Materials testing, Clearance and Control of additives.
Our analytical experience includes work with such diverse products as peptides, metallo-drugs, medical devices, nutraceuticals, excipients and packaging materials. Pharmaceutical tests on these products includes: Heavy metals (USP <232> and <233>), Residual solvents (USP <467>), Residual catalysts (ICP-MS), and Stability & Dissolution Testing.
Additional Biologics and Biopharmaceutical testing services include:
- Process Impurities & Additives
- Silicones and antifoams (Final Bulk Product)
- Tungsten (Glass Syringes)
- GLP Extractables/Leachables studies (Design & Implementation)
Facility and Equipment
Maxxam offers a comprehensive suite of services based on advanced mass spectrometry as well as a number of supplementary liquid and gas chromatography detection methods including:
- Inductively Coupled Optical Emission Spectroscopy (ICP-OES)
- Inductively Coupled Plasma Mass Spectroscopy (ICP-MS & LC-ICP-MS)
- Gas Chromatography (MS, ECD, FID, Headspace, SPME)
- Liquid Chromatography (MS, MS/MS, UV, RI, FSA, Conductivity, Amperometry)
Our GxP laboratory facility incorporates many state of the art features including:
- Back-up generator
- Secure and fireproof data archives
- Remote monitored security access
- Remote temperature monitored & alarmed Freezers and Refrigerators