An Experimental Approach

1. By GMP Pharma Institute Pvt. Ltd.
Drug Substance Solid:
Acid – Base: NA
Oxidative: Optional
Photo-stability: √
Thermal: √
Thermal-Humidity: √
Drug Substance
Solution / Suspension:
Acid – Base: √
Oxidative: √
Photo-stability: Optional
Thermal: NA
Thermal-Humidity: NA
Drug Product Solids
(Tablets, Capsules, Blends):
Acid – Base: NA
Oxidative: √
Photo-stability: √
Thermal: √
Thermal-Humidity: √
Drug Product Solutions
(IV, Oral Suspensions):
Acid – Base: Optional
Oxidative: √
Photo-stability: √
Thermal: √
Thermal-Humidity: NA
Forced Degradation Study
An Experimental Approach
Testing Stressed samples is required to:
Evaluate stability of Drug substance and Drug product in solution,
Determine structural transformations of the drug substance and drug product,
Detect low concentrations of potential degradation products,
Detect unrelated impurities in the presence of the desired product and product-
related degradants,
Separate product-related degradants from those derived from excipients and intact
placebo,
Elucidate possible degradation pathways,
Identify degradation products that may be spontaneously generated during drug
storage and use, and
Facilitate improvements in the manufacturing process and formulations in parallel
with accelerated pharmaceutical studies.