Transdermal Formulation Stability Testing

Drug stability research aims to determine the range of drug stability through a series of tests, and standardize the packaging, storage, transportation, and use of drugs, to ensure the quality of drugs used by patients and achieve the effectiveness and safety of drugs.

About Transdermal Formulation Stability Testing

The purpose of stability testing is to examine the changes in raw materials or preparations over time under the influence of temperature, humidity, and light, and provide a scientific basis for the production, packaging, storage, transportation, and use of drugs. CD Formulation offers versatile storage conditions and testing capabilities to comply with regulatory standards for various stability testing needs, including real-time stability testing, long-term and accelerated stability studies, forced degradation, photostability, in-use testing, and subsequent stability testing.

What Can We Offer

Our drug stability tests mainly include influencing factor tests, accelerated tests and long-term tests. Drugs with temperature requirements, such as refrigerated and frozen drugs, also need to undergo transportation stability tests and freeze-thaw cycle tests.

Influencing factors test

Also called a strong explanation experiment, it examines the impact of various extreme factors such as high temperature, high humidity, light, vibration, oxidation, acid and alkali, and other related conditions on the product. Influencing factor tests include high-temperature tests, high humidity tests, strong light irradiation tests, repeated freezing and thawing, low-temperature tests, oxidation tests, acid and alkali tests, etc.

Accelerated testing

By increasing the temperature and humidity, the chemical or physical changes of the drug are accelerated to explore the stability of the drug. The accelerated test is to place the sample at 40℃±2℃ and a relative humidity of 75%±5% for 6 months.

Long-term test

It refers to the stability test conducted within the set storage conditions, simulating the state of the marketed product, and considering the influencing factors, accelerated test results, and other factors such as climate zone, and considering the packaging form, storage conditions, re-inspection period or shelf life. Long-term tests are generally conducted at 25℃±2℃, relative humidity of 65%±5% or 30℃±2℃, relative humidity of 65%±5% for 12 months or 24 months or other periods.

Our Workflow for Stability Testing of Transdermal Formulation

Fig.1 Flow chart of stability testing. (CD Formulation)

1. Prepare Test Samples: Ensure sufficient test samples are prepared according to the production process of the patch to guarantee their representativeness.
2. Set Test Conditions: Establish appropriate test conditions, including temperature, humidity, and time, based on the experiment's purpose and in accordance with pharmacopoeia standards.
3. Conduct Timed Testing: Test the samples at predetermined time intervals (e.g., monthly, quarterly, semiannually, etc.) and document the values of the various indicators.
4. Statistical Analysis and Quality Evaluation: Analyze the collected test data statistically, create trend charts, and assess the quality stability of the patch throughout its storage period.

Our Technology Platform

• Forced degradation test
• Real-time stability test
• Long-term stability test
• Medium-term stability test
• Accelerated stability test
• Usage stability test

Our Advantages in Transdermal Formulation Stability Testing

We have a wide range of ICH drug stability storage stability conditions:

• 25℃ / 40% RH
• 25℃ / 60% RH
• 30℃ / 25%RH
• 30℃ / 35%RH
• 30℃ / 65%RH
• 40℃ / 75%RH
• Storage temperature is 5℃±3℃
• Ultra-low temperature storage -20ºC, -40ºC, -80ºC

Published Data

CD Formulation provides you with professional stability testing for transdermal formulations according to ICH guidelines. 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.