Photostability is needed to control the photosensitivity and stability of drug products. Protheragen-ING Lab specializes in providing comprehensive and professional photostability testing services for new Active Pharmaceutical Ingredients (APIs) and preparations in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. Our state-of-the-art facilities and experienced team ensure accurate and reliable results to support your product development and regulatory requirements.
Professional pharmaceutical photostability test
Our photostability testing services encompass the following areas:
a. API Testing:
We conduct rigorous photostability testing on the API to evaluate its photosensitivity and establish appropriate test methods.
b. Testing Preparations with Inner Packaging Removed:
We perform photostability testing on the preparation with the inner packaging removed, if necessary. This step helps evaluate the photosensitivity of the preparation without the protection of the inner packaging.
c. Testing Preparations without Outer Packaging (with Inner Packaging):
In some cases, it is essential to test the preparation without the outer packaging while keeping the inner packaging intact. This testing allows us to assess the photosensitivity of the preparation under specific conditions.
d. Preparation Testing for Market Packaging:
We offer comprehensive photostability testing on the preparation with its market packaging. This testing ensures that the packaging provides adequate protection against light and maintains the stability of the product during storage and distribution.
Our test light source
Our testing facilities are equipped with various light sources that comply with the D65/ID65 emission standard, simulating natural daylight conditions. These light sources include:
- Artificial Daylight Fluorescent Lamps
- Xenon Lamps
- Metal Halide Lamps with Visible-UV Output
- Cool White Fluorescent Lamps
- Near Ultraviolet Lamps
For each photostability study, we carefully select the appropriate light source based on the photosensitivity of the API or preparation, ensuring accurate and reliable results.
Photostability studies of APIs
We understand the importance of thorough analysis in evaluating the photosensitivity of APIs. This photostability testing service includes two important components:
Forced Degradation Testing:
Forced degradation testing is designed to evaluate the overall photosensitivity of raw materials. We test APIs and simple API solutions/suspensions to validate analytical methods. Exposure conditions are carefully selected based on the photosensitivity of the drug and the intensity of the selected light source. If excessive sample degradation occurs, the study can be terminated. Observed decomposition products that are unlikely to be produced under normal conditions provide valuable information for establishing and validating analytical methods.
Confirmation Testing:
Following forced degradation testing, we conduct confirmation studies to provide information necessary for storage, packaging, labeling, and other aspects of the API. Typically, a batch of samples is tested during the development phase. If the photostability properties of the drug are identified, a batch of samples may be selected to confirm these properties. However, if the confirmation studies do not provide sufficient clarity, two additional batches of samples are tested according to guidelines and requirements.
Photostability studies of formulations
In addition to the tests described above, we fulfill the specific requirements of different formulations:
- Some formulations, such as aluminum tubes or cans, have been shown to have inner packaging that is completely protected from light. For such formulations, direct exposure testing is usually sufficient.
- For formulations such as infusions and skin creams, additional tests are required to verify their photostability during use. The design of these tests depends on the specific method of use and our experienced team can provide guidance and advice.
- All analytical methods used during testing are rigorously validated to ensure accuracy and reliability.
Why choose Protheragen-ING Lab?
- Experienced Team.
- State-of-the-Art Facilities.
- Regulatory Compliance.
- Customized Approach.
- Timely Results.
Contact us today to discuss your photostability testing requirements and let our expert team assist you in ensuring the stability and quality of your APIs and preparations.