Chemical Stability Assays

Creative Bioarray provides Chemical Stability Assays to determine the degradation of drugs under different conditions. These assays are carried out using various media, including simulated intestinal fluid (SIF), simulated gastric fluid (SGF), or buffers of different pH values.

Why is it necessary to determine drug chemical stability?

• Chemical stability of the drug includes reactions such as hydrolysis, dehydration, oxidation, photochemical degradation, or reaction with excipients.
• The constant presence of water and oxygen in our environment means that exposure to moisture or oxygen can affect chemical stability.
• Oral administration is the preferred route for new drugs. Compounds must remain chemically stable in the stomach under the low pH environment. Therefore, knowing whether a compound is stable in the low pH environment in vitro is essential information for predicting the suitability of oral administration.
• When assessing chemical stability, whether the compound degrades into toxic products and maintains potency in the intended dosage form are points of interest.
• Drug formulation, storage, and packaging need to be adjusted accordingly for chemically unstable compounds to reduce their chemical degradation.

Our Capabilities

• Hydrolysis, dehydration, oxidation, photochemical degradation, or reaction with excipients
• Stability in different pH buffers
• Stability in simulated gastric fluid (SGF)
• Stability in simulated intestinal fluid (SIF)

Brief Protocol

• The compounds were incubated with different buffers (or other conditions the customer requested).
• The mixture was then transferred into ice methanol.
• The concentration of undegraded compounds was detected using LC-MS/MS.

Study Example

Figure 1. Degradation kinetics of [6]-gingerol and [6]-shogaol in simulated gastric fluid (a and c) and 0.1M HCl (b and d). The amount of [6]-gingerol (◆) and [6]-shogaol (■) at time (t) were determined by HPLC (Bhattarai, 2007).

Quotation and ordering

If you have any special needs or questions regarding our services, please feel free to contact us. We look forward to cooperating with you in the future.

References

1. FDA. Guidance for Industry. Drug Stability Guidelines. (2008)
2. Wang, Binghe, Longqin Hu, and Teruna J. Siahaan. Drug delivery: principles and applications. John Wiley & Sons, 2016.
3. Bhattarai, Sushila; et al. "Stability of [6]-gingerol and [6]-shogaol in simulated gastric and intestinal fluids." Journal of pharmaceutical and biomedical analysis 45.4 (2007): 648-653.

Explore Other Options

• In Vitro Metabolism
• In Vitro Permeability and Transporters
• Drug-Drug Interaction
• High-throughput ADME Screening
• Physicochemical Characterization Assays

• Aqueous Solubility Assays
• Lipophilicity and pK_a Assays

For research use only. Not for any other purpose.