Photostability Testing
Save on the expenses of purchasing and maintaining photostability equipment by outsourcing to Sampled’s team of experts. Our up-to-date and validated instrumentation means we are always ready to handle any of our client’s needs.
What is Photostability Testing?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) seeks to unify international standards for testing substances or devices intended for human use.
Under ICH, the Q1B guidelines focus on testing the photostability of a drug or substance upon exposure to light. Photostability testing is an essential component of product development and is mainly used for the submission of registration applications for new molecular entities and associated drug products. Photostability also tests the effect of heat caused by exposure to the light source. Photostability, along with thermal cycling and stability storage is required for alignment with regulations. Failure to accurately perform photostability testing can have serious consequences for consumers and companies.
Why Use Sampled’s Photostability Testing Service?
Reduce Costs
Most companies perform photostability testing once every few years, which means their photostability equipment is mostly unused. Photostability instrumentation is expensive, occupies space, and needs to be validated, tested, and serviced regularly. By outsourcing to Sampled, you only pay for photostability facilities as and when you need them.
Validation & Expertise
Here at Sampled, we serve hundreds of clients and perform photostability testing regularly. This means our expert team performs testing that is up to date with new regulations using validated instrumentation. By outsourcing to Sampled, you don’t need to worry about expertise or equipment. We handle everything.
Photostability Testing Applications
We serve a wide variety of clients across the life science, medical device, BioTech, pharmaceutical, and cosmaceutical sectors. We are equipped and licensed to test a nearly infinite variety of drugs, cosmetics, substances, and devices.
Some applications of our photostability testing service include:
- Drug testing
- Clinical trials
- Cosmetics testing
- Nutraceutical testing
- Vaccines
- Medical device testing
- Drug discovery
- Research studies
How Does Photostability Testing Work?
ICH Q1B Guidelines
ICH is a set of guidelines for providing evidence on the quality of a substance or device for human use. Within the ICH, Q1B guidelines provide instruction on photostability testing of new pharmaceutical drug substances and products. Tests are typically performed in batches and are repeated if any changes are made to a product.
Light Source
There are two options for the light source used in photostability testing:
Option 1: Exposure to any source similar to D65/ID65 emission
Option 2: Exposure to a cool white fluorescent and near ultraviolet lamp
Either can be used. At Sampled we use option 2 because it offers the fastest turnaround time for our clients.
Procedure
Confirmatory studies must prove that samples are exposed to light providing an overall illumination of not less than 1.2 million lux hours and an integrated near ultraviolet energy of not less than 200 watt hours/square meter.
Calibrated UV and LUX sensors are used to ensure that the above parameters are met. A dark control, consisting of a duplicate sample wrapped in aluminum foil is used for comparisons. The exposure takes 5-14 days for the above parameters to be achieved. Once they have been achieved both samples are removed, the test sample is wrapped in foil and both are sent back to the client for testing. We then send the client the experimental data so they have proof it was performed to regulatory standards.
We regularly replace our bulbs to keep trials within expected client timescales.
What Are the Input Requirements for Photostability Testing?
At Sampled we can perform photostability testing on a huge array of drugs, substances, medical devices, and cosmetics. The input requirements depend on what the client wants to test. This includes but is not limited to:
- Pharmaceuticals
- Bulk pharmaceutical chemicals
- Cosmetics
- Nutraceuticals
- Vaccines
- Medical devices
Find out more about our photostability testing services
Looking to outsource your photostability testing? Get in touch with one of Sampled’s experts today to discover how we can solve all of your photostability testing needs.
