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Transdermal Formulation Impurity Analysis

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Identifying and controlling impurities and degradants in active pharmaceutical ingredients (API) and finished products is a critical aspect of the drug development process when assessing drug safety. CD Formulation can provide you with expert impurity and degradation product analysis services.

About Transdermal Formulation Impurities and Degradation Products

Drug impurities refer to any substance that affects the purity of the drug. According to ICH Q3A, Q3B, and other guidelines, impurities are usually divided into the following categories:

Impurities	Description
Organic impurities	Including synthetic byproducts, degradation products, reagents, and solvent residues of APIs. Some have known structures, while others have unknown structures. They may increase during production and storage.
Inorganic impurities	Such as catalyst residues, inorganic salts, etc. The structures are generally known and determined.
Residual solvents	Residual organic solvents are used in the synthesis and preparation process. The toxicity is recorded, so the control limit is known and will not increase during storage.
Other impurities	Such as microbial contamination, migration of packaging materials, etc.

What Can We Offer

We can provide you with impurity analysis services according to relevant regulations such as the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP), including but not limited to:

Elemental impurity detection
Residual solvent analysis
Impurity separation technology
Impurity structure identification
Impurity quantitative analysis

Our Workflow for Impurity Analysis of Transdermal Formulation

Fig.1 Flow chart for impurities and degradation products testing. Fig.1 Flow chart of impurity analysis testing (CD Formulation)

Prepare Instruments: Select the appropriate instruments based on the analysis method, such as High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Mass Spectrometry (MS), Inductively Coupled Plasma Mass Spectrometry (ICP-MS), etc.
Sample Preparation: Randomly select representative samples of transdermal preparations from the production batch. Perform the necessary pretreatment on the samples, such as dissolution, dilution, and filtration, to prepare them for subsequent impurity analysis.
Impurity Analysis Process: Inject the pretreated sample solution into the instrument for analysis. Utilize the test results from the instrument to identify and quantify the impurities present in the transdermal preparations.
Data Analysis and Reporting: Conduct statistical processing of the analysis data, calculate the impurity levels, and compare them against the standard limits. Compose an impurity analysis report that encompasses the analysis methodology, instrument details, sample information, analysis outcomes, and conclusions, among other relevant details.

Our Technology Platform

Our pharmaceutical impurity testing uses a variety of techniques:

Technologies		Description
High-Performance Liquid Chromatography (HPLC)	Commonly used to detect organic impurities and residues in drugs.
Gas Chromatography (GC)	GC is suitable for detecting volatile organic impurities, especially residual solvents and reactants.
Mass Spectrometry (MS)	Mass spectrometry is often used in conjunction with chromatography techniques, such as GC-MS and LC-MS. It can provide accurate mass and structural information on compounds and is particularly useful for identifying unknown impurities.
Nuclear Magnetic Resonance (NMR)	NMR technology can provide detailed information on the structure of compounds and can be used to verify the structure and purity of drugs.

Why Choose Us for Impurity Analysis of Transdermal Formulation?

We have professional technicians with rich experience and expertise in drug analysis. Familiar with ICH (Q3A) Impurities in New APIs and (Q3B) Impurities in New Drug Products guidelines.
We are equipped with the latest analytical equipment and technology to provide accurate and reliable analysis results.
We have a complete testing process and standard operating procedures (SOPs) to ensure the efficient conduct of analysis.

Published Data

Technology: Methods to identification, characterization, and quantification of impurities

Journal: Journal of AOAC International

IF: 1.6

Published: 2017

Results: In the study, a new HPLC method was developed and validated based on ICH guidelines concerning specificity, accuracy, sensitivity, and system suitability. Furthermore, we also proposed possible mechanisms for their formation. Our approach shows potential for quality control and stabilizing process-related impurities and degradation products in a sample analyzed using SAFM.

Fig.2 Overlaid HPLC chromatograms of the blank run and spiked sample run (Liang Zou, et al., 2017)

CD Formulation can provide you with expert impurity and degradation product analysis services. If you have any needs, please feel free to contact us and our colleagues will contact you within three working days.

References

Liang Zou, Lili Sun. Identification, Characterization, and Quantification of Impurities of Safinamide Mesilate: Process-Related Impurities and Degradation Products. Journal of AOAC International. 2017. Vol. 100, No. 4.

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.

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