Stability Assays

The physicochemical stability of the drug substance or preparation has a decisive influence on the formulation, packaging, storage and transportation of the drugs. By determining the stability of active pharmaceutical ingredients, chemical degradation can be reduced by changing the pH of the pharmaceutical formulation, removing moisture from the formulation, storing the drug at lower temperatures, or protecting the drug from light. Chemical stability assays from BOC Sciences can evaluate compound degradation in various media, including simulated gastric fluid (SGF), simulated intestinal fluid (SIF), or buffers of varying pH.

During production and transportation of pharmaceutical molecules, hydrolysis, dehydration, oxidation or photochemical reactions may lead to compound degradation. Generally, highly labile compounds are not suitable drug candidates because it may be difficult to maintain an effective therapeutic dosage form. Therefore, whether a compound degrades to toxic substances and maintain the expected dosage form and potency is an important concern when evaluating the chemical stability of pharmaceuticals. Furthermore, oral administration is currently the preferred route of drug delivery. In the low pH stomach environment, the compounds must remain stable. Therefore, understanding the stability of compounds in various pH environments in vitro is also an important information for predicting the applicability of oral administration.

Real-Time Stability Assays

Real-time stability testing typically requires longer observation of the drug within the recommended shelf life for the product to degrade significantly. During testing, data are collected at appropriate frequencies and conclusively analyzed for their composition, efficiency, and response to various conditions. The reliability of the data is then increased by comparing the regularly tested data to a single batch of reference material with established stability characteristics. With years of efforts, BOC Sciences is equipped with comprehensive analytical technology and experienced team to ensure the high quality and safety of products.

Accelerated Stability Assays

Accelerated stability testing of pharmaceuticals is performed to obtain the amount of heat input required for the active ingredient to fail under high temperature. The shelf life of the product is determined by predicting the duration of safe use and retention of therapeutic value when it is in accelerated degradation conditions. BOC Sciences has developed a systematic stability research laboratory to determine the effect of stress conditions such as temperature, moisture, light, agitation, gravity, pH and packaging on active pharmaceutical ingredients. We have established strict acceptance criteria to ensure the accuracy of the shelf life of test samples. Additionally, we can select packaging materials and containers for specific active pharmaceutical ingredients based on test results.

Retained Sample Stability Assays

Retained sample stability testing is routine for every marketed product requiring stability data. In retained sample stability testing, at least one batch of selected stability samples is retained each year. When more than 50 batches are sold, it is recommended to take stability samples from both batches for preservation. At a later stage, stability samples can be reduced to 2% to 5% of the market batch. For example, when a product has a shelf life of 5 years, it is usually tested at 3, 6, 9, 12, 18, 24, 36, 48 and 60 months. BOC Sciences' experienced professional team is dedicated to helping pharmaceutical companies determine the retained sample stability of their products. We provide comprehensive stability testing services at an extremely cost-effective price.

Cyclic Temperature Stress Assays

Cyclic temperature stress testing is mainly designed according to the specific product situation to simulate the possible conditions in the market storage. Cyclic temperature stress testing can simulate conditions such as the recommended storage temperature, minimum temperature, maximum temperature, and specific chemical-physical degradation of the product in a controlled environment and expose the sample to these conditions for 24 hours. In addition, it is generally recommended to cycle this test 20 times to obtain reliable research data. BOC Sciences has the ability to provide complete stability research solutions to meet customer's applications such as product development, shelf life assessment, packaging material development, and more.

Over the years, BOC Sciences' chemical stability testing services has been committed to providing drug stability assays items such as microbial by-product growth, degradation product formation, crystalline by-product formation, chemical viscosity, and moisture. We rely on the ICH stability testing guidelines to provide authoritative stability testing reports, including the effects of temperature, humidity, light and packaging on the shelf life of drugs. If you are looking for a reliable partner for stability testing of your pharmaceutical products, please contact us to learn more.