Our company has extensive experience in preformulation and analysis of active pharmaceutical ingredients (APIs). We can provide one-stop APIs and excipients hygroscopicity evaluation services to study the potential impact of moisture on the physical and chemical properties of APIs and excipients, supporting pharmaceutical formulations. If you have any needs, please contact us.
Our Services
Hygroscopicity, also known as "moisture sensitivity", can be defined as the susceptibility of a solid to absorb and retain moisture from the environment. Most APIs are highly hygroscopic in their solid form. High hygroscopicity can lead to many problems such as changes in their physicochemical properties, which in turn lead to difficulties in formulation processes, instability during shelf life, and ultimately detrimental to their bioavailability Influence. Therefore, the water content of solid APIs and excipients, either alone or when formulating pharmaceutical dosage forms, is a parameter that should be monitored throughout the drug development process. Hygroscopicity evaluation has become a routine preformulation assay.
At our company, we use dynamic vapor sorption (DVS) to evaluate the hygroscopicity of APIs and excipients, which accurately measures the change in APIs and excipients mass as the water concentration around the sample changes. DVS is a gravimetric technique that combines microbalance, gas flow, and vapor measurements. In the DVS method, the sample to be tested is placed on a microbalance, and a certain concentration of gas with water vapor passes through the sample to be tested at a set flow rate and temperature, and the mass of the sample on the microbalance is read to reveal the moisture adsorption/desorption behavior of the sample.
| Services | Hygroscopicity evaluation of APIs, Hygroscopicity evaluation of excipients |
| Relative humidity range | 0 to 98% |
| Average particle size | 5°C to 85°C |
| Control accuracy | ± 0.1°C |
Advantages
- Accurate and sensitive measurement of water vapor adsorption and desorption isotherms.
- The sensitivity is high, and the mass change of the sample is less than one ten-thousandth of a gram, which can also be determined.
- Predicts the moisture concentration at which APIs and excipients are most stable and the final moisture concentration of the formulation.
Delivery
| Water vapor sorption isotherms | Adsorption/equilibrium rate |
| Water absorption/loss kinetics | Other experimental data |
Please kindly note that our services are for research use only.
