Stability Testing (Pharmaceutical)

Stability Testing (Pharmaceutical)

Pharmaceutical stability testing determines the shelf life of drug products under various storage conditions. Understanding how a drug product changes over time under the influence of environmental factors like temperature, humidity, and light is essential for establishing appropriate storage conditions and expiry dates.

We help manufacturers establish expiry dates and storage conditions for their formulations through comprehensive stability programs designed per ICH Q1A(R2) guidelines and regulatory requirements of major health authorities.

Types of Stability Studies

• Accelerated Stability Testing (40°C / 75% RH)
• Long-term Stability Testing (25°C / 60% RH or 30°C / 65% RH)
• Intermediate Stability Testing (30°C / 65% RH)
• Photostability Testing (ICH Q1B)
• Freeze-thaw Studies
• In-use Stability Studies
• Forced Degradation / Stress Testing

Dosage Forms Tested

• Tablets and capsules (solid oral dosage forms)
• Oral liquids, syrups and suspensions
• Injectables and parenteral products
• Topical formulations (creams, ointments, gels)
• Ophthalmic and nasal preparations
• Herbal and nutraceutical products

Parameters Evaluated

• Assay (potency) and related substances / degradation products
• Physical appearance, color, and odor
• Dissolution (for solid oral forms)
• pH and viscosity (for liquid forms)
• Microbial limits
• Packaging compatibility

Regulatory Compliance

Stability programs are designed to meet ICH Q1A(R2), ICH Q1B, ICH Q1C, CDSCO/DCGI requirements, WHO Technical Report Series, and US FDA guidelines for stability testing of new drug substances and products.