If you are in to pharmaceutical manufacturing you shall need to conduct pharmaceuticals stability testing on your products containing drugs and substances. The testing mainly encompasses chemical, microbiological and physical attributes of your pharmaceutical products and is designed to enhance their quality and popularity in the market.
What is stability testing for pharmaceuticals?
The testing provides testimonials on the quality of the drugs or products under different environmental conditions including high humidity, temperatures and sun exposure. The test also provides evidence on how your product will react under varying conditions. The testing also includes attributes that are vulnerable to changes while the products are being stored and how the changes will influence on the quality, efficacy and safety of the product. As mentioned earlier the Pharmaceuticals Stability Testing mainly covers physical, microbiological and chemical attributes.
Physical – factors taken into consideration during testing will include appearance, water content, melting point, pH, color of solution, clarity, dissolution, Viscosity, disintegration attitudes, particle size and crystal modification.
Microbiological – testing will include microorganism growth, preservative content efficiency antimicrobial and antioxidant contents.
Chemical – assessment of product, such as degradation, residual solvents and related substances.
Long term studies by frequent tests should be enough to establish the stability of a pharmaceutical product for a given period of time. If your drug substance is proposed to have a re-test schedule of 12 months, the test frequency will be for 3 months in the beginning year under storage conditions. It will be for every 6 months in the following year and there after annually for re-testing. Four time points are the recommended test frequency for transitional storage conditions. It will include the first and last time points during the course of a 12-month study.
If storage conditions are accelerated the test frequency will change and the recommended number is a minimum of 3 time points, which will also cover the first and final time points during a study of 6 months. Drug substances must be evaluated under storage climatic conditions so as to test its sensitivity to moisture and thermal stability.
High quality pharmaceutical test chambers are essentially used to conduct the testing so products are accurately evaluated to meet the various pharmaceutical testing parameters. It is highly important that you only install reliable pharmaceutical testing equipment/chambers if you want your drug products to attain the highest quality name in the market.
What is drug stability?
Drug stability can be defined as a pharmaceutical dosage form’s ability to maintain its physical form and appearance, chemical, microbial and therapeutic properties while it is being stored and used for treating patients. Stability of the drug is measured by the frequency or rate of changes that occur to the pharmaceutical dosage form that is in subject.
As a pharmaceutical manufacture it is Important that you abide by the norms applied by the stability protocol mandatory. Now obeying the protocol can severely affect the quality of your drug substances and products resulting into the fall out of your product from the market and its salability.