Pharmaceutical, Nutraceutical & Cosmetic OTC Stability Programs – Our Stability Studies Comply with FDA Requirements (ICH Guidelines)
Stability Chambers/Programs (ICH GUIDELINES)
Stability storage and testing is required in order to assign expiration dating and release products for commercialization. Our in-house chambers are calibrated and design to set expiration dating and stability conditions for pharmaceutical, dietary and nutraceutical over-the-counter products.
Stability testing provides FDA required data on the quality of the finished product over a specific time under the conditions of temperature and relative humidity. Upon every pull that is due, testing is performed on the finished product.
Various Parameters for Stability Programs
PharmaTech’s Analytical Laboratory can perform the following:
- Accelerated Stability: 40 Degrees Celsius +- 2 Degrees Celsius / 75% RH +- 5% RH
- Intermediate Stability: 30 Degrees Celsius +- 2 Degrees Celsius / 65% RH +- 5% RH
- Long-Term Stability: 25 Degrees Celsius +- 2 Degrees Celsius / 60% RH +- 5% RH
Stability Samples & Forms:
- NDA’s / ANDA’s / OTC’s
- Controlled Substances / Drug Substances
- Sample Forms: Liquids / Powders / Tablets / Caplets / Capsules / Creams / Ointments / Gels
- 2-year and 3-year expiration dating on finished products upon completion of stability programs.
- Stability Storage for both Pilot Batch Samples and Pilot Commercial Batches
- Method Development and Validation to support stability studies
- Finish Product Release based on testing results