Drug stability studies are analyses performed in pharmaceutical industries, with the objective of evaluating how a drug will be affected by different environmental conditions over time. These studies are an integral part of many manufacturing processes in this type of industry, since they allow demonstrating that an error-free and properly functioning final product was obtained.
The results of drug stability studies support the proposed approval, testing and/or modification of the shelf life or labeled storage conditions of a drug product. The time to conduct stability studies can range from weeks, months or even years, depending on product requirements. They are based on exposing the drug to environmental conditions that may occur along the supply and storage chain, evaluating parameters such as temperature, humidity and exposure to light, as these conditions may cause a drug to deteriorate or lose efficacy.
What is the purpose of drug stability studies?
Drug stability studies aim to document the changes that drugs manufactured in the pharmaceutical industry may undergo, both at physicochemical and microbiological levels, when exposed to different environmental conditions, temperature, humidity or exposure to light. The objective of these tests is to define precisely and specifically the storage conditions of the product, the most suitable type of container and packaging for it, and to establish its shelf life for drugs.
The stability of drugs will be seriously influenced by environmental factors such as temperature, humidity and ambient light, as well as by other factors specific to the product: the physical and chemical properties of the active ingredient it contains and also of the excipients it contains. in the product, the manufacturing process for its transformation, as well as the container closure system used, the properties of all the materials from which the container has been manufactured and the compatibility between the container and the product.
How are drug stability studies performed?
Drug stability studies are performed inside pharmaceutical stability chambers. This equipment works by recreating, maintaining and controlling parameters such as constant temperature and relative humidity inside the chambers, thus simulating the conditions at the destination sites of the drugs in order to test the efficacy of the drugs during their shelf life. In these tests, parameters that indicate product stability, such as organoleptic properties, potency if corresponding to the product and dissolution, related substances, microbial count, pH and other parameters, must be analyzed according to the dosage form.
These drugs will be subjected to different types of conditions during stability studies, in order to analyze the possible changes that these conditions could generate in the quality of the drug in extreme situations of environmental exposure. This type of studies allow the analysis of pharmaceutical chemical products and products of biological origin including proteins, polypeptides and conjugates.
Applications of drug stability studies
Drug stability studies can first evaluate the efficacy of drugs against various conditions, such as temperature, humidity, pH, radiation, etc. They are also used to test how long the product can be used without losing its efficacy. These tests also provide information on the integrity of the product packaging.
These studies also make it possible to determine under what environmental conditions a drug could cause toxicity or present an error, saving a great deal of time and avoiding large losses to the industry. As well as determining the expiration date of any drug.
What does Kalstein offer you?
Kalstein is a manufacturer of medical and laboratory equipment of the highest quality and the best technology at the best prices in the market, so you can make your purchase with confidence with us, knowing that you have the service and advice of a company specialized in the field. and committed to providing safe, economical and effective options to perform their functions in the right way.
This time we introduce our YR053286 // YR053288 Comprehensive Drug Stability Test Chamber. It consists of a novel illumination stability test chamber for pharmaceutical companies for drug failure evaluation, accelerated testing and long-term testing of special equipment. Its main features include:
- World-famous compressor: balanced refrigeration technology, automatic defrosting, multiple safety system, long operation, environmental protection, high efficiency and energy saving.
- Automatic defrost function: original rapid defrosting technology with heat pump for continuous operation effectively prevents freezing due to continuous evaporator operation.
- Manual control system of cooling effect: meets customer’s terrible working environment.
For more information, we invite you to take a look at HERE
