PRODUCT
STABILITY
ANALYSIS

Home / Products Stability Analysis

PRODUCT STABILITY ANALYSIS

Products used for animal health are tested during product development and to ensure quality standards are met. These range from dip-wash analyses to newly formulated products.

Stability Product Testing

Stability testing is utilized to determine if the quality of a drug/food substance or drug/food product is altered over time by various environmental factors, such as light, temperature, and humidity.

Two common types of stability tests are real-time and accelerated. Real-time tests are accomplished by storing pharmaceutical products according to the recommended conditions and checking or monitoring the product until it fails.

The storage conditions are usually prescribed by the ICH/WHO and SAHPRA guidelines which are a set of guidances to ensure safe, effective and high-quality medicines are developed and registered efficiently. These guidelines have been adopted by regulatory authorities throughout the world.

The climate is different in all the countries in the world and stability studies should be done according to the climatic conditions of the country. According to the WHO guidelines for stability studies the climate of the world is divided into five different zones.

Zone	Type of climate	Long-Term Testing Conditions
Zone I	Temperate Zone	21 ⁰C / 45 % RH
Zone II	Mediterranean/subtropical zone	25 ⁰C / 60 % RH
Zone III	Hot dry zone	30 ⁰C / 35 % RH
Zone IVa	Hot humid/tropical zone	30 ⁰C / 65 % RH
Zone IVb	Hot/higher humidity	30 ⁰C / 75 % RH

Accelerated testing is usually performed at 40 0C / 75 % RH for a 6-month period.

How stability test is done?

7 Steps for Stability Testing

Step 1: Batch Production.

Step 2: Product Container Filling.

Step 3: Initial Test (Time Point Zero). Full analyses and description of container.

Step 4: Product Storage at the customer specified conditions.

Step 5: Product Evaluation at various set time points (usually 3, 6, 9, 12, 18 and 24 months for long-term storage.

Step 6: Determine Stability. This from product specification guidelines.

Step 7: Conclusion Report.

Airsep can assist in both the storage and testing of you product and ensure a dossier is developed for product registration purposes.

STABILITY TESTING

Stability testing of stock remedies is also undertaken. This may include, equivalence testing and 5 batch analysis. Assistance is given with new product development.

PRODUCT STABILITY ANALYSIS