Formulation Stability Study

Overview

Stability is one of the important indicators of the quality of pharmaceutical preparations, which directly affects the potency and safety of drug products throughout the shelf life. It is of great value to study the stability of pharmaceutical preparations. This study not only ensures that pharmaceutical products remain stable and effective under recommended storage conditions, but is also considered a prerequisite for the approval of pharmaceutical product.

Factors Affecting the Stability of Pharmaceutical Preparations

The stability of pharmaceutical preparations is affected by many factors, mainly including the following aspects:

• Light: Many drugs are sensitive to light and are prone to photolysis, photo-oxidation and other reactions, which can lead to a decrease in the quality of the drug.
• Temperature: Pharmaceutical preparations have different stability at different temperatures. In general, the higher the temperature, the worse the stability of pharmaceutical preparations.
• Humidity: Too high or too low humidity may cause decomposition, oxidation, hydrolysis and other reactions of the pharmaceutical preparation, which may lead to the decrease of the quality of the drug.
• pH Value: Drug molecules may undergo ionization, hydrolysis, polymerization and other reactions in an inappropriate pH range.

Our Services

Influencing Factor Test

The influencing factor test generally includes high temperature, high humidity and light test. The purpose of the influencing factor test for pharmaceutical preparations is to examine the rationality of the preparation prescription, the production process and packaging conditions, and to provide a basis for the screening of the preparation process, the selection of packaging materials and containers, and the determination of storage conditions.

Accelerated Stability Test

Accelerated stability test is a commonly used method to evaluate the stability of pharmaceutical preparations. In accelerated stability test, the drug product is stored at elevated stress conditions such as acceleration temperature, humidity, light, agitation, pH, and gravity. The purpose of the test is to predict the stability of a pharmaceutical preparation under actual conditions of use by accelerating its chemical or physical changes.

Long-Term Stability Test

Unlike accelerated stability testing, long-term stability testing involves monitoring the stability of the formulation over a long period of time under normal storage conditions. This test provides data support to confirm packaging, storage conditions and validity/reinspection period.

ICH Stability Zones

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has established the following different climate zones to guide the pharmaceutical industry in formulation stability testing.

Table 1. ICH Climate zones and long-term stability conditions.

Why Choose Us

• Expertise: Our company has a team of experienced scientists with extensive expertise in formulation development and stability testing. Our team can provide comprehensive support throughout the formulation stability study process.
• Quality Assurance: Our company adheres to strict quality assurance procedures to ensure the accuracy and reliability of stability study data. This includes adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) where appropriate.
• Timely Delivery: Our company understands the importance of timely delivery in the pharmaceutical industry. We strive to deliver reliable stability study results within agreed-upon timelines, helping you achieve development and regulatory milestones.