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Method Development & Method Validation for Solubility and Dissolution Curves

CD Formulation specializes in providing one-stop pharmaceutical formulation analysis services, including pre-prescription studies, prescription process development, analytical method development and validation, scale-up production, process validation production, stability studies, and other pharmacological development services. The core members of our team are pharmacology and medical research experts with rich experience in drug formulation development and analytical method development and validation work.

Method Development & Method Validation for Solubility and Dissolution Curves

Background

The solubility of a new drug is the first parameter that should be measured, and with the knowledge of this parameter, appropriate considerations can be made for the selection of formulation dosage forms and for the prescription, process, crystalline form of the drug, particle size, etc. Solubility can be expressed in concentration units such as mass molar concentration, molar fraction, molar ratio, weight/volume ratio, weight/weight ratio, etc. Accurate determination of the aqueous solubility of drugs is very important for understanding quality control and drug delivery issues of pharmaceutical formulations, and is influenced by the physicochemical properties of the drug, the nature of the medium, and the control of the solubility determination parameters. CD Formulation has extensive experience in drug solubility testing, solubility determination methods, and solubility curve analysis.

Our Services

CD Formulation provides analytical method development and method validation services for solubility and solubility profile testing. Based on extensive experience and expertise, our pharmacologists, medical and chemists perform analytical method development for solubility and solubility curves, followed by method validation to ensure the accuracy of analytical assay results.

Method Development & Method Validation for Solubility and Dissolution Curves

Method Development for Solubility & Solubility Curve Testing

Solubility testing methods

  • Saturation concentration measurement

This method is used to measure the solubility by adding the drug to the medium until it starts to precipitate and the concentration of the drug in the excipient is no longer increasing.

  • UPLC/HPLC technique

When using liquid lipid excipients, UPLC/HPLC can be used to determine the equilibrium solubility of the drug.

  • Differential thermal scanning calorimetry (DSC) & hot stage microscopy (HSM) techniques

When semi-solid lipid excipients are used, differential scanning calorimetry (DSC) and/or hot bench microscopy (HSM) can be used for relevant measurements.

Solubility curve method development

Solubility curves are obtained by continuous dynamic method testing.

Assay Method Validation

In order to examine whether the analytical assay methods described above have excellent results for solubility and solubility curves, we performed method validation services. The method specificity, linearity, range, accuracy, repeatability and intermediate precision are evaluated to ensure the validity and reliability of the method.

Advantages of Our Services

  • Professional experimental team with rich experience in method development and method validation.
  • Complete quality assurance system to ensure development quality.
  • Well-configured and advanced instruments and equipment to provide guarantee for high-efficiency development.
  • Efficient service with short cycle time.

If you have a requirement about our services, please contact us by phone or email, our colleagues will reply to you within three working days.

Online Inquiry

Please note: Our products and services can only be used for research purposes. Do not use in diagnostic or therapeutic procedures!

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