How is a drug stability study done?

July 28, 2022by Kalstein

Drug stability studies are analyzes conducted in pharmaceutical industries, with the aim 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 to show that a final product was obtained free of errors and that it works properly.

Results of drug stability studies support the proposal for approval, testing and/or modification of the shelf life or labeled storage conditions of a pharmaceutical product. The time to conduct stability studies may range from weeks, months or even years according to the product requirement. They are based on exposing the drug to environmental conditions that could occur along the supply and storage chain, evaluating parameters such as temperature, humidity and exposure to light, because these conditions can cause a drug to deteriorate or lose effectiveness.

What is the purpose of drug stability studies?

Drug stability studies aim to document the changes that drugs manufactured in the pharmaceutical industry can experience both at the physical-chemical and microbiological levels, when they are exposed to different environmental conditions, temperature, humidity or light exposure. The aim of these tests is to define precisely and specifically the storage conditions of the product, the type of packaging and packaging most suitable for it, and to establish its shelf life for medicinal products.

The stability of the medicines will be seriously influenced by environmental factors such as temperature, humidity and ambient light, as well as other factors that are specific to the product: the physical and chemical properties of the active substance it contains and also of the excipients contained in the product, the manufacturing process for processing it, as well as the closure system of the used packaging, the properties of all the materials with which the packaging has been manufactured and the compatibility between the packaging and the product.

How are drug stability studies performed?

Drug stability studies are carried out inside the pharmaceutical stability chambers. These equipment work by recreating, maintaining and controlling parameters such as constant temperature and relative humidity inside the chambers, thus simulating the conditions at the places of destination of the drugs in order to check the efficacy of the drugs during their useful life. In these tests, parameters indicating product stability, such as organoleptic properties, potency if applicable to the product, and dissolution, related substances, microbial count, pH and other parameters, should be analyzed according to the pharmaceutical form.

These medicinal products will be subject to different types of conditions during the stability studies, in order to analyze in this way the possible changes that these conditions could generate in the quality of the medicinal product in extreme situations of environmental exposure. This type of studies allow the analysis of pharmaceutical chemicals, and products of biological origin including proteins, polypeptides and conjugates.

Applications of drug stability studies

Drug stability studies can first assess the efficacy of medicines against various conditions such as temperature, humidity, pH, radiation, etc. They are also used to check how long the product can be used without losing its effectiveness. Information on the integrity of the product packaging is also allowed from these tests.

These studies also allow to determine under which environmental conditions a drug could cause toxicity or comes with some error, saving a large amount of time and avoiding large losses to the industry. As well as determine the expiry date of any medication.

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 confidently with us, knowing that you have the service and advice of a company specialized in the field and committed to provide you with safe, economical and effective options to perform your functions in the right way.

This time we present our Comprehensive Drug Stability Test Chamber YR053286 // YR053288. It consists of a novel lighting stability testing chamber for pharmaceutical companies for the evaluation of drug failures, accelerated testing and long-term testing of special equipment. Among its main characteristics are:

  • World-famous compressor: Balanced cooling technology, automatic defrosting, multiple security system, extended operation, environmental protection, high efficiency and energy saving.
  • Automatic defrosting function: original rapid defrosting technology with heat pump, for continuous operation, effectively prevents frost due to continuous evaporator operation.
  • Cooling effect manual control system: meets the customer’s terrible working environment.

For more information we invite you to take a look




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