LGM pharma’s unique mix of API sourcing and CDMO services is fueling robust growth

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. 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. 

How We Work

With over 60 QA/QC/Analytical staff members, cGMP-compliant facilities, and modern equipment, including ICP-MS and ICP-OES, we provide high-quality analytical services. Our three facilities, strategically located in California, Colorado, and Texas, can provide rapid analysis of various samples to meet your tightest timelines.

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
  • 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 no Form 483 observations from the FDA on recent 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.