Analytical Testing

Get High-Quality Analytical Testing at our Modern, cGMP Facilities

LGM Pharma provides analytical and microbiological testing services for drug product and drug substance

To get to market fast you need to focus on what you do best. Trust LGM Pharma to handle analytical testing requirements for drug substance and drug product, including compound pharmacy APIs and drug products. We have the expertise, cGMP facilities and equipment to provide high-quality contract analytical services that meet your budgets and timelines. In addition to analyzing samples using various pharmacopoeia methods, LGM Pharma takes an innovative approach to developing and validating stability-indicating methods for all forms of drug substance and drug product.

Service expansion includes endotoxin and rapid sterility testing

For small and virtual pharmaceutical companies, compounding pharmacies, or those seeking 503(a), 503(b), and 505(b)2 regulatory pathways, LGM Pharma now offers endotoxin and rapid sterility testing for sterile compounds. This service expansion:

Significantly accelerates turnaround times, reducing costs
Enhances quality control for in-demand sterile injectables including peptides.

New capabilities and equipment at our Irvine, CA facility mean we can provide:

5-day incubation periods – vs. 14 days with traditional compendial methods – for faster submissions and product launches
PCR-based testing for greater sensitivity, accuracy, reproducibility and faster detection
Affordable, flexible, and rapid testing for sterile products, including injectables
Compliance with global regulations
Supply chain consolidation – full analytical testing from one provider

How We Work

Whether you engage with us through our facilities strategically located in California, Colorado, or Texas, you’ll find deep expertise and care among our 60+ QA/QC/Analytical staff members. Working in cGMP-compliant facilities with modern equipment – including ICP-MS and ICP-OES – under a robust quality management system, we provide comprehensive analytical services for rapid analysis of a range of samples to meet your tightest timelines. These are available as stand-alone services or as part of our CDMO services.

Analytical Method Development and Validation Services

Analytical target profile identification
Critical quality attributes identification

Validation of analytical procedures

Identification tests
Quantitative tests for impurity content
Limit tests for the control of impurities
Quantitative tests of the active moiety in various samples

For drug substances and drug products:

ID
Assay
Impurities
Residual solvents
Wet chemistry tests
Elemental impurities

Validated methods include (but are not limited to):

Chromatographic techniques such as TLC, HPLC, UPLC, GC
Spectrophotometric techniques such as IR, UV, ICP-MS, ICP-OES, AA
Titrimetric methods
Microbiological assays
Bioburden testing
Bacterial endotoxin testing (BET)
Rapid sterility testing
Other methods such as fluorimetry, gravimetry, LOD, KF, Dissolution, X-ray Diffraction, Laser Diffraction Particle size characterization, and Sonic/Air Jet Particle size analyzer

Quality is a cornerstone at LGM Pharma

Our analytical method development and validation processes follow the highest standards – meeting all current Good Manufacturing Practices (cGMP) and following ICH guidelines. We’re proud of our regulatory track record with the FDA on inspections of our development, manufacturing, and testing facilities.

With over 60 QA/QC/analytical staff members, cGMP-compliant facilities, and modern chromatography and spectroscopy equipment, including ICP-MS and ICP-OES, we provide high-quality analytical services so you can focus on what you do best.