Quality control (QC) and release testing are critical steps to ensure the safety, efficacy, and consistency of transdermal formulations before they are released to the market. CD Formulation offers a comprehensive range of transdermal formulation testing solutions to help you meet these challenges.

About Quality Control and Release Testing for Transdermal Formulations

We have decades of experience in quality control and release testing of transdermal formulations. Quality control and release testing of transdermal formulation involves a combination of physical, chemical, microbiological, and performance testing to ensure safety, efficacy, and consistency. These tests are critical to meeting regulatory requirements and ensuring product quality before it reaches consumers. We can help you identify critical quality attributes and design the right release test combination to help you quickly complete your pharmaceutical analytical testing requirements.

What Can We Offer

• Transdermal Formulation API and Excipient Characterization
• Transdermal Formulation Analytical Method Development and Validation
• Transdermal Formulation Analytical Method Transfer
• Transdermal Formulation Batch Release Testing
• Transdermal Formulation Residual Solvents Testing
• Transdermal Formulation Elemental Impurities Testing
• Transdermal Formulation Extractables and Leachables Testing
• Transdermal Formulation Impurity Analysis
• Transdermal Formulation Stability Testing
• Transdermal Formulation Temperature Cycling Testing
• Transdermal Formulation Forced Degradation Testing
• Transdermal Formulation Packaging Integrity Testing
• Transdermal Formulation Bioequivalence Evaluation

Our Technology Platform

Analytical method development and phase-appropriate method validation

• 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 validation of elemental impurities, quantitative testing services, elemental semi-quantitative full scan screening tests
• Package Integrity: Verify that the packaging maintains integrity and protects the formulation from environmental factors.
• Accelerated stability: Accelerated aging studies are performed to predict shelf life under various conditions.
• Long-term stability: Evaluate the stability of a formulation over an extended period to determine shelf life.

Stability storage and testing under ICH-controlled conditions

• 25°C, 60% RH
• 30°C, 65% RH
• 30°C, 75% RH
• 40°C, 75% RH
• Photostability studies in accordance with ICH

We ensure that all test methods comply with regulatory requirements (e.g. FDA, EMA) and follow Good Manufacturing Practices (GMP). We fully document all test results, deviations, and corrective actions taken during quality control and release testing.

Our Technology Platform

Why Choose Us for Quality Control and Release Testing for Transdermal Formulations?

• We have deep expertise to help you determine the correct, minimum test combination.
• We have a variety of cutting-edge analytical technologies and methods and have accumulated rich technical experience in drug release testing. We can deal with various complex situations and ensure the comprehensiveness and depth of testing.
• Testers have received professional training and are familiar with various release test methods and standards. They can accurately perform tests and analyze results.
• We have an in-depth understanding of drug-related regulations and standards and can ensure that drug release testing complies with relevant regulatory requirements.
• We can provide customized service solutions based on the individual needs of customers to meet the different needs of different customers.

Our transdermal formulation expertise helps ensure the quality, safety, and effectiveness of your products. If you have any needs, please feel free to contact us and our colleagues will reply to you within three working days.