Transdermal Formulation Residual Solvents Testing

Residual solvent testing of pharmaceutical products is the focus of pharmaceutical analysis and an important part of pharmaceutical quality control. Because residual solvents may be harmful to human health and the environment, it is necessary to ensure that they are not present in transdermal formulations or are only present below the recommended acceptable level. CD Formulation offers expert services for testing residual solvents in transdermal formulations to guarantee the safety and reliability of the products you utilize.

About Residual Solvents Testing for Transdermal Formulations

Residual solvents in drugs are organic volatile chemicals that are used or produced in the production of raw materials or excipients, as well as in the preparation of preparations, but are not completely removed during the process. Residual solvents may change the properties of drugs, such as changing the crystal form of certain drugs and increasing the moisture absorption of drugs, which will affect the quality of drugs. On the other hand, the toxicity and carcinogenicity of residual solvents have increasingly attracted the attention of pharmaceutical management departments in recent years. Therefore, residual solvents in drugs should be removed as much as possible and controlled in limited quantities.

Fig.1 Chromatoprobe diagram (Christopher J. Poronsky, et al., 2017)

What Can We Offer

Our testing scheme is divided into active pharmaceutical ingredients (APIs), pharmaceutical excipients, finished drugs, and pharmaceutical packaging materials according to the test objects:

Residual solvents in APIs

APIs are manufactured through complex chemical reaction processes. Specific organic solvents are introduced during the manufacturing process, but some of these organic solvents are not completely removed during the process.

Residual solvents in pharmaceutical excipients

Pharmaceutical excipients may also use some organic solvents during the production process. If these solvents remain, they may eventually be introduced into the finished drug.

Residual solvents in finished drugs

The ingredients of finished drugs include both APIs and various pharmaceutical excipients added during the production of preparations. These ingredients and the production process of preparations may also introduce residual solvents into the finished drug.

Residual solvents in pharmaceutical packaging materials

The packaging materials of drugs are usually made of polymer materials and metal films. These materials are prone to residual solvents during the production process. The ink will also introduce some residual solvents into the drug packaging materials during the printing process.

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Our Workflow for Residual Solvents Testing of Transdermal Formulation

Fig.2 Flow chart of transdermal formulation residual solvents testing. (CD Formulation)

1. Sample Preparation: In accordance with the test method requirements, the sample should be properly processed, such as by cutting or dissolving, to ensure it is suitable for analysis.
2. Analytical Testing: Samples are subjected to the selected analytical technique, such as Gas Chromatography (GC) or Liquid Chromatography (LC), to separate and quantify residual solvents.
3. Data Analysis: Peak areas or heights from the sample are compared to those from calibration standards to determine the concentration of each residual solvent.
4. Reporting: Results are assessed against regulatory limits to determine compliance and a report is generated to document the findings.

Why Choose Us for Residual Solvents Testing of Transdermal Formulation?

• Professional team: We have a professional testing team with rich experience and technical capabilities in testing residual solvents for transdermal formulations.
• Advanced equipment: We use internationally advanced testing equipment and instruments to ensure the accuracy and reliability of test results.
• Comprehensive testing: We provide comprehensive transdermal formulations residual solvent testing services, covering a variety of common solvents and toxic and hazardous substances.

Published Data

Residual solvent testing in transdermal formulations is crucial for ensuring product safety, quality, and compliance with regulatory standards. 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.