Formulation Stability Study

Research on the stability of pharmaceutical preparations provides a scientific basis for the determination of production, packaging, storage, transportation conditions and the validity period of pharmaceutical products. This is achieved by investigating the parameters of the changes of API properties and preparations with time under the influence of temperature, humidity and light, so as to ensure the safety and effectiveness of clinical medication. Stability evaluation is one of the main components of drug quality control research. It is closely related to drug quality research and the establishment of quality standards.

The research on preparation stability is featured by phases and links all steps in drug R&D.
Different placement conditions for stability study based on different formsDifferent investigation items based on different formsDifferent packaging materials based on different formsInvestigation of physicochemical properties and stability of drugs Scheme design of stability study, project management, storage and detection of samples for stability study, data trend analysis, and evaluation of drug shelf life
Content of stability study
Stability of global drug registration; experimental/exploratory stability (pre-experiment); and stability of drugs after approval for marketComprehensive services such as scheme design, project management, stability sample storage and testing, data trend analysis, drug shelf-life evaluation and NDA/MAA filing document preparationStorage: 40°C/75%RH, 30°C/75%RH, 30°C/65%RH, 25°C/60%RH, with proper lighting, or the storage conditions specified by the customer, including 2-8°C, -20°C, -70°C, 25/40, 30/35, 40/20 and 50/40 (new)Qualified constant temperature and humidity box (IQ/OQ/PQ certified) for stability study; multi-channel power supply; Real-time temperature and humidity monitoring (dual system); and automatic alarm system;Three batches (filing batches) of pilot-scale stability test Investigation of influence factors with packages of one batch of samples removedInvestigation of influence factors during production with packages of one batch of samples retained for potential analysisAcceleration test of three batches of samplesIntermediate condition test of three batches of samplesLong-term test of three batches of samples

FAQ

What is Stability of a Drug?

The stability of a drug refers to the degree to which the physical, chemical, biological and microbial properties of an active substance or formulation can be maintained within prescribed limits during its entire storage and use.

Relevant laboratories

Relevant articles

Consistency Evaluation Preformulation Study Formulation Stability Study GMP-based Clinical Sample Production & Packaging Pilot-scale Preparation Testing Laboratory-scale Preparation Testing