Transdermal Formulation Forced Degradation Testing

Forced degradation testing involves a series of tests that subject the raw material drug or formulation to relatively severe conditions to evaluate its stability. CD Formulation specializes in providing professional forced degradation testing services for transdermal formulations.

About Forced Degradation Testing of Transdermal Formulation

A forced degradation test is one of the contents of stability research, also known as a destructive test or strong degradation test. It causes the degradation of drugs under special artificial conditions, such as acid, alkali, oxidation, high temperature, light, etc., and verifies the feasibility of the detection method by measuring the degradation products and analyzing the possible degradation pathways and mechanisms of the drugs.

What Can We Offer

Our forced degradation mainly includes four mechanisms: high temperature, hydrolysis, oxidation, and photostability.

Thermal stability

Solid APIs and preparations should be exposed to dry heat and wet heat at the same time. The recommended destruction temperature should be 10°C higher than the accelerated test temperature, and the relative humidity should be 75% or higher.

Acid-base hydrolysis

APIs and preparations should be subjected to acid-base hydrolysis destruction tests in solution at room temperature or higher. The choice of acid and base type and concentration depends on the characteristics of the drug itself.

Oxidative destruction

The choice of oxidant type and concentration depends on the properties of the drug itself. APIs are in solution, and preparations are in solution or solid-state for oxidative destruction.

Photostability

APIs and solid/liquid preparations should be exposed to conditions with a total illumination of not less than 1.2 million Lux·hr and near-ultraviolet energy of not less than 200W hr/m². The same sample should be exposed to both fluorescent lamps and near-ultraviolet lamps.

Our Workflow for Transdermal Formulation Forced Degradation Testing

Fig.1 Flow chart of forced degradation testing. (CD Formulation)

1. Select Destruction Conditions: Choose the appropriate conditions for destruction, such as the concentrations of acid, alkali, and oxidizing agents, the temperature of destruction, and the appropriate duration of the process.
2. Record Degradation Data: Document the degradation products and pathways under various degradation conditions. Analyze the characteristics and quantity of these degradation products.
3. Analyze Drug Stability: Assess the stability characteristics of the drug by comparing the outcomes from different degradation conditions.
4. Report Test Findings: Compile a report of the test results, encompassing the test conditions, analytical methods, principal findings, and conclusions.

Our Technology Platform

Why Choose Us for Transdermal Formulation Forced Degradation Testing?

• Our laboratory is equipped with several special instruments for impurity research, such as gas chromatography-mass spectrometry (GC-MS, GC-MS/MS), liquid chromatography-mass spectrometry (LC-MS/MS), ion chromatography (IC), liquid chromatography (LC-FLD), etc.
• We have a complete range of testing instruments and professional testing technicians and can provide strong degradation test services under various conditions including acid, alkali, high temperature, light, etc.
• We are customer-centric and provide personalized service solutions to ensure that customers have a satisfactory experience during the testing process.

Published Data

CD Formulation provides you with professional forced degradation testing for transdermal formulations. 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.