Stability analysis is a vital part of drug development and production, and it is the basis for the formulation of product quality standards. BOC Sciences provides you with comprehensive stability analysis services from the development stage to the listing stage. We have enough storage space to store all the analysis data of each stage. Our analysis equipment and data management system are in compliance with current regulations, and we strive to become your most trusted partner for stability analysis solutions.
What is Drug Stability Analysis?
Stability is a crucial quality attribute (CQA) of medicines. It affects the efficacy and safety of drugs, and also provides a basis for the production process, formulations, packaging materials, storage, and transportation conditions of the drugs. The stability assessment of a drug is not static from the beginning of its establishment. It needs to be updated and modified continuously with the modification of the formula, the change of the process and the analysis method. Stability test mainly includes influencing factor test, accelerated test and long-term test. Accelerated stability testing can represent long-term testing and will not cause degradation pathways that are not present in the nominal storage environment. Once the long-term stability data is obtained, the accelerated stability estimates can be calibrated and corrected.
What Can We Offer?
- Formulate a drug stability plan according to the needs of customers, and formulate a detailed stability evaluation plan, including a series of test categories, test samples, test items, test conditions, test time, etc.
- Introduce the most advanced data management programs and statistical analysis software for data collection and analysis.
- During the project, the management of different batches of samples will be stored in containers and closed systems of the same material as those used in large-scale production.
- Establish reasonable results evaluation methods and acceptable acceptance criteria, analyze different inspection items separately, and comprehensively evaluate the results of product stability tests.
- Judge the consistency between different batches of the same project stability research results; perform trend analysis on the stability data collected at different time points for the same batch of products.
- According to the analysis structure, formulate the storage conditions and validity period (preservation period) of the product, and formulate the maximum acceptable variation range of each index according to the characteristics of the product to ensure that the product is safe and effective throughout the validity period.
Drug Stability Testing
The purpose of stability testing is to provide the necessary evidence to demonstrate how the quality of a drug substance or drug product changes over time under the influence of a variety of environmental factors (such as temperature, humidity, and light). As well as determining the retest period for the drug substance and the effective shelf life of the drug product and recommended storage conditions. At each stage of development, formulation modifications, process changes, and analytical method improvements are made, allowing stability assessments to be challenged, updated, and revised. In addition, stability analysis is also an important part of drug registration and marketing, which has far-reaching significance for promoting the sustainable and healthy development of the biopharmaceutical industry.
Influencing Factor Testing
The main factors in any stability study are time, batch and environmental factors. The main environmental conditions are humidity and temperature. A risk assessment should be completed to evaluate any other environmental factors to which the drug may be sensitive. In addition, there are factors related to the drug product and drug substance that may affect stability, such as pH, excipients, API content concentration and retention time, and these factors should be included in the overall stability assessment and drug development process. BOC Sciences develops and validates drug stability analysis methods to provide you with various types of biopharmaceutical stability analysis. We evaluate accelerated stability, short-term and long-term stability of drugs through physical and chemical properties, structure verification, aggregation, biological activity, visual appearance, impurities, etc.
Accelerated Stability Testing
Accelerated stability testing mainly examines the effects of temperature and humidity on drugs. The conditions are lower than the influencing factors and higher than the normal storage conditions. The purpose is to study the stability of pharmaceutical preparations by accelerating the chemical or physicochemical changes of drugs, so as to provide necessary data and information support for product prescription design, process improvement, quality research, packaging design, product transportation, and storage. Before conducting accelerated stability studies, temperature and humidity conditions need to be selected based on the properties and characteristics of different formulations. The basic steps for our accelerated stability study are as follows:
1. Determine the purpose of accelerated stability studies
2. Select acceleration factor conditions and ranges to be included in the accelerated stability studies
3. Determine the time period in hours, days or weeks
4. Model the acceleration period and degradation rate under each temperature or storage condition
5. General conditions for the model at any temperature or storage condition
6. Stability prediction under normal storage conditions (validity period, degradation rate and acceleration factor)
7. Calibrate or correct accelerated stability studies with long-term stability studies to ensure they are valid and predictive
8. Verify the matching between accelerated stability studies and long-term stability studies
Long-term Stability Testing
Long-term testing is carried out under the actual storage conditions of the drug or close to the actual storage conditions of the drug, and its purpose is to provide a basis for formulating the validity period of the drug. As with accelerated stability studies, temperature and humidity conditions need to be selected based on the properties and characteristics of different formulations before long-term stability studies are carried out. Our long-term test conditions for preparations include temperature-insensitive drugs (conventional preparations), temperature-sensitive drugs (refrigerated preparations), frozen pharmaceutical preparations and special packaging containers (pharmaceutical preparations packaged in semi-permeable containers).
Transport Stability Testing
Any pharmaceutical preparation will face transportation problems after leaving the factory, so pharmaceutical preparations should conduct transportation stability studies. In preliminary research, vibration conditions can be used to simulate transportation to examine product stability, so as to understand in advance whether the product is stable during handling, vibration, and shaking during transportation, which can provide reference for subsequent product transportation stability research. As the time to market approaches, it is necessary to conduct a real transportation stability investigation based on the transportation distance, vibration amplitude, and frequency based on product market conditions. If refrigerated drugs are used, the impact of temperature deviations such as cold chain detachment on pharmaceutical preparations must also be investigated.
Stability testing is the basis for all drug development and production. All organizations need to have a clear vision of the appropriate stage of stability research design, organizational data collection, appropriate data analysis, clear stability reports, and available analytical methods to achieve product development goals that stabilize product entry into consumers and markets, and meet all regulatory requirements submitted. You can believe that our one-stop stability program can speed up the entire drug development cycle to the maximum extent and ensure product quality. We are committed to using our expertise to ensure your success. If you are interested in our stability analysis service, please contact us immediately.