Transdermal Formulation Elemental Impurities Testing

Elemental impurity research team at CD Formulation can provide transdermal formulation elemental impurity testing services based on ICH guidelines and relevant requirements of various countries' pharmacopeias. Our team has accumulated rich work experience is equipped with high-end instruments and equipment and has completed elemental impurity research services for more than 100 varieties.

About Elemental Impurities Testing of Transdermal Formulations

The control of impurities in the drug production process is crucial to drug safety. Elemental impurities cannot provide therapeutic effects for patients and may affect the safety and effectiveness of the final pharmaceutical product. Some studies have shown that elemental impurities may be the cause of various cancers and neurological diseases. Therefore, relevant regulations, such as ICH Q3D, USP <233>, etc., have put forward requirements for the control of elemental impurities in raw materials, formulations, drug packaging materials, and medical devices.

What Can We Offer

CD Formulation is equipped with an ICP-MS inductively coupled plasma mass spectrometer, which can provide you with the following detection methods:

Our Workflow for Elemental Impurities Testing of Transdermal Formulation

Fig.1 Flow chart of elemental impurities testing. (CD Formulation)

1. Prepare Instruments: Select the appropriate instruments based on the test method, such as an Inductively Coupled Plasma Mass Spectrometer (ICP-MS) or an Inductively Coupled Plasma Optical Emission Spectrometer (ICP-OES).
2. Sample Preparation: Pre-treat the sample to minimize matrix interference and extract elemental impurities. Pre-treatment methods may include direct dissolution, acid digestion (e.g., wet digestion, microwave digestion), among others. The specific method should be chosen based on the sample characteristics and test requirements.
3. Test Process: Prior to testing, calibrate the instrument to ensure its accuracy and stability. Inject the pre-treated sample solution into the instrument for analysis. Calculate the content of elemental impurities in the sample based on the instrument's test results.
4. Data Analysis and Reporting: Conduct a statistical analysis of the test data and compare it with standard limits to evaluate whether the content of elemental impurities in the transdermal preparation meets the requirements. Compile a test report that includes details such as test methods, instrument information, sample details, test results, and conclusions.

Why Choose Us for Elemental Impurities Testing of Transdermal Formulation?

• Our professional technical team is equipped with advanced IC, ICP-MS, digestion equipment, and other equipment; with high sensitivity, it can accurately detect ppb level.
• Our technicians have rich testing experience and have completed more than 100 varieties of elemental impurity research services.
• We can determine element control strategies according to customer requirements and realize customized solutions.

Published Data

We can provide you with method verification of elemental impurities, quantitative testing services, elemental semi-quantitative full scan screening testing services, etc. If you have any needs, please feel free to contact us and our colleagues will reply to 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.