Are you confident that your pharmaceutical products will maintain their quality over time? The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) offers comprehensive guidelines for stability testing of new drug substances and products. These studies are designed to assess how a pharmaceutical product’s quality evolves under different environmental conditions such as temperature, humidity, and light exposure. ICH stability studies for pharmaceuticals are a crucial part of drug development, ensuring long-term product integrity and playing a key role in quality assurance.
Looking for a partner who can help guide your stability storage studies? Here’s how the team at Purple Diamond can help.
ICH Stability Studies for Pharmaceuticals at Purple Diamond
ICH stability studies for pharmaceuticals ensures the quality, efficacy, and safety in the development of drugs, medicines, and controlled substances produced are kept meeting the highest standards.
At Purple Diamond, we have the experts and equipment to test a variety of use cases when it comes to your pharmaceutical product.
- Stability of New Drug Substances and Product Lines. For this we place samples inside multiple different test chambers simulating many different environmental conditions.
- Photostability of New Drug Substances and Product Lines. For this we test the sensitivity the product has to light.
- Stability of New Dosage Forms. This is the testing of new dosage amounts, which can change over the course of a certain drug’s tenure.
In addition to ICH stability testing, our team at Purple Diamond is specialized in several other services relative to ICH:
- Test For Impurities in New Pharmaceutical Products
- Provide Microbial Examinations of Non-Sterile products
- Join In Quality Risk Management Consultations
- Give Pharmaceutical Quality System Recommendations
- Pharmaceutical Products Lifecycle Management
- Provide On-Going Research and Development of Pharmaceutical Products
- Validate Stability Study and Storage Procedures
Partner with Purple Diamond for Reliable Results
Purple Diamond offers specialized stability testing tailored to meet the specific storage needs of your pharmaceuticals. With state-of-the-art laboratory chambers that include continuous monitoring, backup power, and 24/7 security, our team ensures the protection and integrity of products throughout the entire testing period.
Contact us today to learn how our ICH stability studies for pharmaceutical can support your product development and ensure regulatory compliance.
