Transdermal Formulation Analytical Method Development and Validation

The quality of transdermal formulations needs to be tested from multiple angles and levels, and multiple items need to be tested to ensure the quality of transdermal formulations. Different analytical methods can be used for each test item. To make the test results accurate and reliable, the scientificity, accuracy, and precision of the analytical method need to be verified to fully demonstrate that the analytical method meets the requirements of the test items. CD Formulation can provide you with various analytical method verification services.

About Transdermal Formulation Analytical Method Development and Validation

The purpose of method validation is to determine whether the analytical method used is scientific and reasonable and whether it can effectively control the quality of drugs. According to the requirements of the test items, certain validation contents are set in advance, and reasonable tests are designed to verify whether the analytical method used meets the requirements of the test items. The validation test items are identification, impurity inspection (limit test, quantitative test), quantitative determination (content determination, dissolution, release, etc.), other specific test items, etc. The validation contents include the method's specificity, linearity, range, accuracy, precision, detection limit, quantitative limit, durability system applicability, etc.

What Can We Offer

The services we can provide you include but are not limited to the following:

• Method development and validation for drug content and excipient content
• Method development and validation for in vitro permeation testing (IVPT)
• Method development and validation for in vitro release testing (IVRT)
• Method development and validation for microbiological testing
• Residual drug testing
• Strong degradation testing

Our Workflow for Analytical Method Development and Validation of Transdermal Formulation

Taking the development of API analytical methods as an example, our process is as follows:

Fig.1 Flow chart of transdermal formulation analytical method development and validation. (CD Formulation)

1. Determine analytical objectives and requirements: Before developing API analytical methods, clarify analytical objectives and requirements. Including determining the compounds to be analyzed, the sensitivity and accuracy of the analytical method, etc.

2. Determine analytical methods: Select analytical methods based on analytical objectives and requirements.

3. Method optimization and validation: After determining the analytical method, optimize and validate. Containing determining analytical conditions, evaluating the reliability and accuracy, etc.

4. Sample preparation and analysis: After optimizing and validating the analytical method, perform sample preparation and analysis.

5. Data analysis and report writing: After completing sample analysis, analyze and process the data to determine the content and purity of the compound, etc. Finally, an analytical report needs to be written to record the analytical results and methods.

Why Choose Us for Analytical Method Development and Validation of Transdermal Formulation?

Our transdermal patch analysis methods are equipped with a variety of advanced instruments, including but not limited to:

Published Data

Our analytical method development and validation for transdermal patches are carried out through careful experimental design and rigorous experimental execution to ensure the accuracy and reliability of the results and safeguard the quality and safety of your products. If you have any needs, please feel free to contact us and our colleagues will contact you within three working days.

How It Works

STEP 1

Submit a service request describing your specific research or development need.

STEP 2

We'll email you to provide your quote and confirm order details if applicable.

STEP 3

Execute the project with real-time communication, and deliver the final report promptly.