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

Stability Services

Custom, ICH, and Registration Stability Services

On-Site Stability Chambers Enable Comprehensive Stability Services

Ensure patient safety and the profitability of your drug product with comprehensive, timely, and high-quality stability study services.

As part of LGM Pharma’s broader analytical testing capabilities, stability studies are performed on Phase 1, Phase 2, and Phase 3 clinical batches and finished drug product in the final marketed container/closure system.

 Complete Stability Services Capabilities

Studies are designed and conducted on-site in stability chambers under the following ICH-recommended testing and storage conditions:

  • 2-8 °C
  • 25 °C (+/-2 °C) at 60% RH (relative humidity)
  • 30 °C (+/-2 °C) at 65% RH
  • 40 °C (+/-2 °C) at 75% RH

Contract stability testing services include:

  • cGMP registration stability
  • Real-time stability testing
  • Accelerated stability testing
  • Forced degradation stability studies
  • Formulation stability studies
  • Biologics Stability studies
  • Freeze/Thaw cycle studies

Trust LGM with Your Stability Data

Your custom or ICH-mandated stability protocol yields client-specific reporting: time-point stability data reports and a final stability report with all supporting data, prepared by LGM stability specialists.

LGM Pharma provides the evidence to support shelf-life claims in FDA new drug application (NDA) and abbreviated new drug applications (ANDA). Our reports demonstrate the viability of API, other excipients, and packaging components against light, heat, and humidity over the 24-, 36-, 48-, or 60-month expiry of your drug product.