CDMO Analytical Testing Services

Metrics Contract Services offers analytical testing services for:

• Methods development and validation
• Stability studies
• Raw materials
• Trace metals
• Microbiology

And drug release testing appropriate to the intended dosage form.

Methods development and validation:

• High Pressure Liquid Chromatography (HPLC)
• Gas Chromatography (GC)
• Ion Chromatography (IC)
• Karl Fischer Moisture Titrations
• Particle Size Characterization
• Dissolution and Drug Release
• Other Analytical Techniques

Stability Studies & Storage

• Study protocol development
• Packaging, labeling and storage of product
• Analytical testing
• Data management
• Statistical analysis of data
• Complete reporting – you’ll receive a complete, fully-documented data package ready for submission to the FDA.

Raw Materials Testing

Metrics Contract Services offers a comprehensive range of raw material testing services, meeting both global and domestic compendia:

• Full-service compendial testing, including USP/NF, BP, EP, JP and ACS monographs
• Streamlined preparation and testing procedures to meet rapid timelines. Just-in-time testing system provides for methods on schedules agreed upon with the client. We also offer a 24-hour emergency turnaround option if needed.
• Complete GMP review of all data to ensure quality results

Trace Metals Testing

Our veteran trace metals group delivers true cGMP results with the following services:

• Elemental analysis of raw material, drug substances and drug products
• Complete program for USA 232 and USP 233 Elemental Impurities
• Determination of metal counter ions for drug substance salts
• Method development, validation and transfer
• Conventional and microwave digestion sample preparation
• ICP-MS, ICP-OES, GFAAS, FAAS, and Cold Vapor Mercury instrumentation

You’ll also receive GMP and FDA reporting and documentation support.

Microbiology Testing

Metrics Contract Services offers a wide variety of microbial testing for non-sterile and sterile dosage forms, including:

• solids
• liquids
• powders
• emulsions
• suspensions
• ampoules
• vials
• intravenous bags

Specific testing capabilities include:

• Microbial Limits Testing (harmonized USP  <61> & <62>)
• Antimicrobial Effectiveness Testing
• Particulate Matter Testing
• Bacterial Endotoxin Testing

Other Microbiological Testing

• Sterility Testing
• Antibiotic Assay
• Water Testing
• Water System Validation Services

Founded in analytical services.

Since our early days when Metrics Contract Services was focused solely on providing analytical services, we’ve always understood the importance of robust support for development and manufacturing. Today, as a full-fledged CDMO with more than 90 analytical chemists on staff, we are just as committed to excellence in analytical testing.

State-of-the-art facilities designed for a broad range of substances.

With more than 28,000 square feet of cGMP analytical laboratory space, Metrics Contract Services is both FDA and DEA registered and inspected. The state-of-the-art facility is designed to handle a wide range of compound types including potent, toxic, light-sensitive, temperature-sensitive, DEA-regulated, and other challenging molecules.