Transdermal Formulation Extractables and Leachables Testing

Packaging materials are crucial in ensuring the quality of drugs and medical devices. The study of extractables and leachables is gaining significance in the pharmaceutical industry due to stricter regulatory oversight. CD Formulation offers expertise in conducting extractable and leachable testing, drawing on years of experience in the field.

About Transdermal Formulation Extractables and Leachables Testing

Extractables refer to compounds that can be extracted from packaging or production component materials (plastics, elastomers, glass, metals, and their coatings) under harsh experimental conditions (such as solvents, temperature, and time) using solvents with different physical and chemical properties (solvents of different polarity or solutions similar to the product solution).

Leachables refer to compounds that migrate into drugs from production components, packaging components, or drug delivery devices under normal production processes, storage, and use conditions.

What Can We Offer

There is a certain intersection between extractable impurities and leachable impurities. Except for special impurities in the feed solution, most leachable impurities can be covered by the chemical substances detected by extractable verification. Therefore, potential leachables can be predicted through extractable verification.

We can provide you with the following services:

Extractables testing

We usually conduct simulation tests on packaging components to identify and semi-quantitatively study the extracted compounds. Based on various target species and dosage forms, components are tested using a variety of extraction techniques and solvents of various polarities. Appropriate extraction conditions and analytical methods are selected to predict the extractable generated in specific applications. The extracts are then evaluated using analytical techniques based on sensitivity, detection limit, and target substance characteristics.

Leachables testing

Leachables may be present in the final API and drug product. Due to the limitations of separation and detection methods, their qualitative or quantitative analysis is more difficult than extractable. First, obtain extractable data under reasonable worst conditions and conduct a safety assessment. When the extractable data indicate that there is a large interference or safety risk to the process equipment, consider leachable testing.

Our Workflow for Extractables and Leachables Testing of Transdermal Formulation

Fig.1 Flow chart of extractable and leachable testing. (CD Formulation)

1. Sample Preparation: Randomly select representative samples of the transdermal preparation from the production batch. Pre-treat the samples according to the test method requirements, which may include processes such as cutting, dissolving, and diluting.
2. Test Method Selection: Choose the appropriate test method based on the purpose of the test and the characteristics of the sample. For extract testing, this could involve the extraction and quantitative analysis of specific components within the preparation; for leachate testing, it may focus on the total amount of soluble substances or the leaching of specific components from the preparation.
3. Test Process:

   Extractables Testing

   Extraction: Utilize suitable solvents and methods to extract the target components from the transdermal preparation.

   Purification: Conduct necessary purification steps to remove impurities from the extract.

   Quantitative Analysis: Employ appropriate analytical instruments, such as High-Performance Liquid Chromatography (HPLC) or Gas Chromatography (GC), to quantitatively analyze the purified extract and calculate the content of the target component.

   Leachables Testing

   Leaching: Follow the test method requirements to use water, ethanol, or other suitable solvents to extract the transdermal preparation.

   Filtration and Evaporation: Filter the extract and evaporate it to dryness to obtain the residue.

   Determination: Weigh the residue or further analyze it using techniques such as HPLC or GC to calculate the total amount of extract or the content of specific components.

4. Data Analysis and Reporting: Conduct a statistical analysis of the collected test data to determine indicators such as the content of the target component and the total extract amount. Compile a test report that includes details on the test methods, instrument information, sample information, test results, and conclusions.

Our Technology Platform

• Headspace-gas chromatography-mass spectrometer (HS-GC-MS)
• High-performance liquid chromatography (HPLC)
• Liquid chromatography-tandem mass spectrometer (LC-MS/MS)
• Inductively coupled plasma optical emission spectrometer (ICP-OES)
• Inductively coupled plasma mass spectrometer (ICP-MS)

Why Choose Us for Extractables and Leachables Testing of Transdermal Formulation?

• We use cutting-edge technology and analytical skills to offer thorough extractable and leachable testing methods, tailoring the plan to meet your specific testing needs.
• We have a library of various reference standards for the confirmation of extractable/leachable compounds.

Published Data

Our team of experts will provide you with support and advice on your pharmaceutical packaging challenges. 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.