Our company has extensive experience in the analysis of preformulations and can provide you with a comprehensive solubility testing service to help you improve the bioavailability, stability, and efficacy of drugs. Please do not hesitate to contact us if you have any questions.
Our Services
Solubility analysis of preformulations is one of the important steps in the drug development and manufacturing process. The solubility of active ingredients (APIs) refers to the maximum amount of APIs that can be dissolved in a solution at a specific temperature and pH value. This parameter has an important impact on the formulation design, bioavailability, stability, and therapeutic effect of the drug. Our company's analytical laboratories are equipped with state-of-the-art analytical instruments (e.g., UV-Vis spectrometers, HPLC, etc.) to assess the solubility of APIs under specific conditions, which in turn guides the design and preparation of drug dosage forms.
The general steps of APIs solubility testing include:
Our Methods
| UV-Vis spectroscopy | The concentration of APIs in the solution is determined by measuring the change in absorbance of APIs in the ultraviolet or visible range. |
| High performance liquid chromatography | The APIs in the solution are separated into individual components by high pressure, and the concentration of APIs is calculated by detection. |
| Ion chromatography | Used to analyze the solubility of ionic components in APIs. |
Advantages
- Expertise and experience: With a wealth of experience in the analysis of preformulations, our company possesses deep expertise in the intricacies of solubility testing. This ensures that we provide accurate and reliable solubility data for your drug development process.
- Comprehensive solubility analysis: Our service provides a thorough assessment of the solubility of APIs under specific conditions. This comprehensive analysis takes into account various factors such as temperature and pH, which are crucial in determining the solubility profile of APIs.
- Diverse analytical methods: Our company employs a range of analytical methods to assess APIs solubility. These methods include UV-Vis spectroscopy, HPLC, and ion chromatography. The application of multiple techniques ensures a comprehensive understanding of solubility characteristics, especially for complex drug molecules.
Delivery
Solubility curve: Based on experimental data, draw the solubility curve of APIs at different time points or conditions.
Maximum solubility value: Determine the maximum solubility value of APIs under specific conditions from the solubility curve.
Determination method and experimental conditions: The report will describe in detail the experimental method used to determine the solubility, the solvent used, temperature, pH value, and other conditions.
Dosage form design guidance: To provide guidance for drug dosage form design, as the solubility of APIs is crucial in selecting the appropriate dosage form (e.g. tablet, capsule, etc.) and formulation.
Please kindly note that our services are for research use only.
