AKUMS DRUGS & PHARMACEUTICALS LTD. offers stability testing services to evaluate Drug Product and Drug Substance Stability in accordance with ICH Q1A guidelines.

To support these activities, Akums offers full Analytical Method Development and Qualification, Validated Stability Chambers at all storage conditions, and a Laboratory Information Management System (LIMS) for complete sample and Document Management.

Stability Capabilities:

• ICH Compliant Protocols
• Centralized LIMS for Sample Tracking
• Analytical Method Development
• Long-term Stability Studies
• Accelerated Stability Studies

Stability Testing Methods:

• Potency
• pH and Appearance
• HPLC
• UV
• Sterility
• Endotoxin

Storage Conditions:

• 5°C ± 3°C
• 25°C ± 2°C with 60% RH ± 5% RH
• 30°C ± 2°C with 65% RH ± 5% RH
• 40°C ± 2°C with 75% RH ± 5% RH