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Stability Studies

Controlled pharmaceutical stability studies are conducted to determine the shelf life and expiration date of a drug substance or product. Certain conditions as well as the passage of time can cause drugs to deteriorate and change, leading to loss of efficacy and the possibility of harmful side effects. To determine this, it’s essential to understand how a drug substance and product behaves under the influence of environmental factors such as temperature, heat and light.

Southwest Research Institute’s CGMP Manufacturing team helps the pharmaceutical industry develop Analytical & Regulated Projects to support early-stage and scale-up across the Pharmaceutical Formulation Development.

We conduct an array of pharmaceutical stability studies, which involve mimicking various climate zones throughout the globe and accelerating the degradation of the drug or formulation which needs to be monitored to maintain a useful drug supply. Many of these tests are required before a drug can be approved by the FDA.

Stability Storage Services

Stability storage services are vital for the recreation of climate conditions in pharmaceutical analysis. SwRI researchers conduct pharmaceutical stability studies according to the World Health Organization’s definitions of climatic zones based on prevailing environmental conditions. SwRI facilities recreate these conditions and perform long-term tests on pharmaceutical formulations to determine their shelf-life in various global regions.

Climatic Zones for Stability Studies

Zone

Description

Examples

Conditions

I

Temperate

Russia, Mayada

21 °C / 45% RH

II

Mediterranean/subtropical humidity

USA, Japan, Europe (portions)

25 °C / 60% RH

III

Hot Dry

Iraq, Syria

30 °C / 35% RH

IVA

Hot Humid/ tropical

Taiwan, India, south Asia

30 °C / 65-70% RH

IVB

Very humid

 

 

Accelerated Storage Stability Testing

While the above denote standard storage conditions, accelerated storage stability testing allows to further predict a formulation’s stability profile. For zone 2, typical accelerated storage stability testing would store materials at 40 °C / 75% RH.  Various tests are conducted to demonstrate a product is stable.

Photostability Testing

Many pharmaceutical formulations can change or degrade due to exposure to light. SwRI provides photostability testing using fluorescent and ultraviolet light exposure to determine a drug’s sensitivity to light.

GMP Stability Test

SwRI offers Good Manufacturing Practice (GMP) stability testing and pharmaceutical analysis services that meet the requirements of regulatory authorities worldwide. Laboratory services supporting GMP stability test requirements range from early development characterization, formulation support analysis, stability testing and method development and method validation through to GMP batch release testing.

ICH Stability Studies

Guidelines governed by The International Council for Harmonisation (ICH) determine how new pharmaceutical products must be tested for stability and quality prior to approval for worldwide distribution. SwRI follows general guidelines for ICH stability studies and can also provide custom testing.

Related Pharmaceutical Services