Solution Stability

Stability refers to the capacity of the pharmaceutical dosage form remain specifications established to ensure its identity, quality, safety and purity during the time of storage and usage by the patient. Stability is an important attribute of drug products quality. Instability of the drug can cause an undesired change in performance, finally leading to product failures. Drugs formulated as solutions (two categories: oral and parenteral solutions) almost always face stability challenges including chemical, physical and microbial stability. The instability of a solution may lead to a precipitate forming, which may not affect the chemical content, but for a parenteral product it is quite unacceptable, and for an oral solution it will also be unsatisfactory. Solution stability is a critical part of the drug development process, and it is a fundamental property of successful drug candidates. For example, for the development of parenteral formulations, the development candidates need to possess good stability and compatibility with different excipients in the formulated solutions to be successful in the clinic.  

Generally, the factors affecting solution stability include temperature, pH, ionic strength, solvent, oxygen and surface. Among them, the solution pH is one of the major determinants of the stability of a compound. Solution stability testing aims to monitor how the quality of drug substance varies with the influence of these environmental conditions. The obtained information is useful for the recommendation of storage conditions and shelf life of drug products. Stability testing is one of the most critical and necessary steps during the development of drug process. It is important to select an experienced stability study and testing outsourcing partner to help you minimize the risks associated with costly stability trials. Alfa Chemistry ' scientists have specialist knowledge for stability testing. We possess advanced stability chamber used for stability testing. In conjunction with our solid state service and analytical laboratory, and with the aid of kinds of instruments such as liquid chromatography-mass spectrometry (LC-MS), high performance liquid chromatographic (HPLC), we conduct stability testing in a planned way in compliance with the guidelines issued by ICH, WHO and or other agencies. We have a track record in delivering pharmaceutical stability testing and stability studies.

Our solution stability services:

RH: Relative humidity

Real-time testing

Real-time testing is commonly carried out under recommended storage conditions and the testing duration is long enough to allow significant product degradation. The testing period mainly depends on the stability of the product. The determination of shelf life is based on real-time testing.

Long-term testing

For pharmaceutical products, long-term testing is conducted under higher temperatures with shorter duration to support in-use stability and shipping conditions.

Accelerated testing

In an accelerated stability testing, the product is usually exposed to high-stress condition, which can enhance the deterioration of the product, and so reduce the time required for testing. Through accelerated stability testing, the stability profile and the shelf life of the product can be predicted before launching into the market.

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