Stability Studies

Stability studies in the pharmaceutical industry are designed to evaluate how the quality of a drug substance or product varies with time under the influence of environmental factors such as temperature, humidity, and light. These studies ensure that pharmaceuticals maintain their safety, efficacy, and quality throughout their shelf life.

ICH guidelines, such as Q1A(R2) for stability testing of new drug substances and products, provide a comprehensive framework for designing and conducting stability studies. These guidelines outline critical aspects of stability testing, including:

• Study Design: Defines the overall structure and protocols for stability studies.
• Testing Parameters: Specifies the attributes to be tested, such as potency, purity, and dissolution rate.
• Storage Conditions: Details the environmental conditions (temperature, humidity, and light) under which the products are stored during the study.
• Documentation Requirements: Outlines the necessary documentation for demonstrating compliance with regulatory standards.

At Tentamus Pharma UK, stability studies are meticulously planned and executed in accordance with ICH guidelines using five in-house stability cabinets. These cabinets provide the controlled environments necessary for testing drugs under various specified conditions:

Temperature Control

Ensures accurate and consistent temperature settings.

Humidity Control

Maintains specified humidity levels for testing.

Light Exposure

Controls light conditions to assess the impact of light on product stability.

Detailed documentation of study protocols, sample analysis results, and conclusions is maintained to demonstrate compliance with regulatory requirements. This includes:

1. Study Protocols - Documenting the detailed plans and procedures for each stability study.

2. Sample Analysis Results - Recording the outcomes of all tests conducted during the study.

3. Conclusions - Summarising the findings and implications for product shelf life and quality.

Commitment to Quality

Tentamus Pharma UK ensures that stability studies are conducted to the highest standards, contributing to the quality, safety, and efficacy of pharmaceutical products throughout their lifecycle. Our commitment to following ICH guidelines and maintaining rigorous documentation practices helps us deliver reliable and compliant stability data to our clients.