ICH Stability & Forced Degradation Studies
Ensure stability and secure the commercial success of your products with SK biotek Ireland Analytical Services
Accurately Monitor Quality And Stability With Us
Assess the long-term stability of your drug substances with SK biotek Ireland Analytical Services. Utilising up-to-date analytical tools, our fully GMP-compliant labs enable us to provide accurate and precise results in compliance with regulations.
Our Available Stability Services Include:
- Protocol writing
- Report writing
- Forced Degradation Studies
- Long-Term Stability Storage & Testing
- Intermediate Stability Storage & Testing
- Accelerated Stability Storage & Testing
- Temperature Excursion/Cycling Studies
Available ICH Storage Conditions:
- 5 °C
- 2 °C – 8 °C
- 25 °C/60 %RH
- 30 °C/65 %RH
- 30 °C/75 %RH
- 40 °C/75 %RH
- -20 °C
- Photostability per ICH Q1B
- Custom storage conditions upon request
The SK biotek Ireland Analytical Services Advantage
SK biotek Ireland Analytical Services offer a full suite of stability and forced degradation analytical services to support drug substance analysis.
Flexible, Tailored Services
Our multidisciplinary team of experts offers ICH stability services that efficiently provide storage, testing and forced degradation studies to support cGMP stability study requirements. SK biotek Ireland Analytical Services furnish a flexible service whereby customers can choose the level of stability or forced degradation support needed.
Value-Added Stability Storage and Analytical Support
We remove the need for clients to invest in expensive stability chambers and equipment. SK biotek Ireland Analytical Services provide cost-effective, controlled storage solutions. We also offer long and short-term stability storage, follow-up pharmaceutical and raw material analyses, and assist companies during drug development and commercialisation.
60 Years of Assurance
With almost 60 years of experience conducting stability studies within our corporate framework of continuous improvement, our team provides the support you need. With SK biotek Ireland Analytical Services’ expertise, you can focus on your core business objectives as we support your product evolution.
The Latest equipment & Talented chemists
Serving your needs, SK biotek Ireland Analytical Services leverage cutting-edge technology and expert staff. Our team of analytical chemists and scientists possess a broad range of experience in stability and forced degradation studies.
Regulation Compliant Assistance
Our analytical laboratories develop and validate stability-indicating methodologies using a variety of technologies. SK biotek Ireland Analytical Services identify, and quantify degradation products in accordance with ICH stability testing criteria.
your reliable Service partner
SK biotek Ireland Analytical Services monitors the quality of your products through reliable results and solutions; via the proﬁciency of our resources, we consistently guarantee on-time stability results throughout the relevant lifecycle of your product.
Expert cGMP Compliant ICH Stability & Forced Degradation Services
SK biotek Ireland Analytical Services offer extensive and comprehensive one-stop stability management solutions.
Bringing quality to life, SK biotek Ireland Analytical Services assures the commercial success of your pharmaceutical products. We offer bespoke Quality Assurance that aids in meeting regulatory standards for your pharmaceutical products.
Our best-in-class stability testing and ICH storage services for drug substances meet your requirements while accelerating your growth!