What is long-term stability testing?
Long-term stability testing is one of the crucial aspects of the pharmaceutical industry. It is designed to assess how the physical, chemical, and microbiological properties of a drug or formulation change over a certain time frame. This test is critical to ensure the continued quality, safety, and efficacy of a drug product.
Our specialized testing services
Protheragen-ING Lab is a professional pharmaceutical service provider specializing in comprehensive and reliable long-term stability testing of pharmaceutical products by the guidelines set by the International Committee for the Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), ensuring that your products meet the highest standards of quality and compliance. Our team has the experience and expertise to ensure the stability and consistency of your drug product throughout its life cycle.
Our process for long-term stability testing services:
1) Study design and program development:
We'll be working with you to define the scope of the stability testing, including test conditions, time points, and analytical methods to be used. Our experts develop a detailed study program based on your product's specific requirements.
2) Sample storage and handling:
We provide optimal storage conditions for your samples to maintain their stability during testing. Our state-of-the-art storage facilities are equipped with temperature and humidity control systems to ensure the integrity of your samples throughout the study.
3) Analytical testing and evaluation:
We perform comprehensive analytical testing on your samples at predetermined points in time. We use proven analytical techniques to evaluate a variety of parameters, including drug potency, degradation products, dissolution, content uniformity, and microbiological properties.
4) Data analysis and reporting:
Upon completion of testing, our experts analyze the collected data and prepare detailed stability reports. These reports include comprehensive analysis, graphical representation, and statistical evaluation of stability data. We provide clear and concise explanations of the results, enabling you to make informed decisions about product shelf life and storage recommendations.
Benefits of our services
- ICH code compliance
Our test methods strictly follow ICH guidelines such as Q1A(R2), Q1B, Q1C, and Q1D to ensure the reliability and comparability of results. Our laboratory facilities and operations meet the highest quality standards to ensure testing accuracy and confidence.
- Diverse testing conditions
We are able to design and perform a variety of test conditions based on the characteristics and requirements of different products. This includes different temperature, humidity, and light conditions. Our goal is to simulate the various conditions that pharmaceutical products may encounter in actual storage and use environments to comprehensively assess their stability and adaptability.
- Advanced analytical equipment
We are equipped with state-of-the-art analytical equipment and instruments that can accurately measure and monitor changes in trace components in drug or formulation samples. Our team is skilled in various analytical techniques, such as high-performance liquid chromatography (HPLC), gas chromatography (GC), mass spectrometry (MS), etc., to ensure comprehensive and accurate analysis of samples.
We look forward to working with you to ensure the quality and reliability of your pharmaceutical products. If you are interested in our long-term stability testing services or have any questions, please feel free to contact us. Our professional team will be happy to provide you with support and answers.