What are the guidelines for a drug stability test?

July 28, 2022by Kalstein

Drug stability testing is an essential part of the entire research and development process that must be done in advance of a pharmaceutical product that will be made available to the public, in order to determine the time during which it maintains its quality specifications. They consist of a series of tests used to verify physico-chemical, biochemical and immunochemical characteristics, molecular entity analysis, qualitative and quantitative detection of degradation products, provided that the purity and molecular characteristics of the drug allow the use of the different analytical techniques.

Biological drugs are constituted by active components that are commonly proteins or polypeptides, in which the conservation of molecular conformation and biological activity depends on covalent and non-covalent forces, which makes them sensitive to environmental factors (temperature, humidity and light), oxidation, ion content, therefore, well-defined storage conditions are needed in order to ensure the conservation of biological activity and prevent its degradation or deterioration.

What is a drug stability test for?

The stability of a finished pharmaceutical product (drug or drug), refers to the property of maintaining over time its original properties within the established specifications, in relation to its quality, safety and efficacy such as identity, concentration or potency, purity and physical appearance, among others.

That is, drug stability tests serve to support a proposal for approval, testing, and/or modification of a drug’s labeled shelf life or storage conditions. These tests consist of exposing the medicinal product to environmental conditions that could occur along the supply and storage chain, studying parameters such as temperature, humidity and exposure to light, because these conditions can cause a medicinal product to deteriorate or lose effectiveness.

What factors can influence the degree and rate of drug deterioration?

Among the main factors that influence the degree and rate of deterioration of drugs are a) environmental factors such as temperature, humidity, light, oxygen and others such as vibration or freezing and b) factors related to the product, among which we can include:

  • Physical and chemical properties of the active substance and excipients, presence of certain impurities, the particular crystalline or polymorphic form, particle size and possible presence of water or other solvents.
  • The pharmaceutical form and its composition.
  • The manufacturing process, including environmental conditions, technological procedures and others such as personnel, equipment, among others.
  • The nature of the container with which the pharmaceutical product has direct contact.

Guidelines for drug stability testing

Drug stability testing chamber applications are required by regulatory authorities to meet the following requirements:

  • Appropriate documentation, including standard operating procedures and periodic reports.
  • Cameras and rooms are equipped with several sensors evenly distributed throughout the controlled area.
  • Multi-level shelving for orderly storage and adequate exposure to the controlled environment.
  • Acceptable monitoring equipment (probes, data loggers, among others).
  • Continuous data recording and absolute traceability.
  • Implement corrective actions when stability factors are out of specification limits

Stability tests are also required to have an alarm function to detect and announce any deviation from the conditions set out in the study. To this end, pharmaceutical industries have implemented various methods to detect and advertise abnormal conditions.

What is ICH?

The ICH (international conference on harmonization) is the International Council for Harmonization of Technical Requirements for Registration of Medicinal Products for Human Use. This board meets with regulatory authorities from Europe, Japan and the United States,

ICH guidelines have now been adopted into law in many countries and are used as guidelines by the FDA, as they set out scientific and technical aspects of drug registration.

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. HERE

For more information we invite you to take a look: HERE




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