Olon USA’s expertise in stable labeling empowers clients to develop cost-effective and precise bioanalytical internal standards. As a trusted partner in the drug development journey, we deliver high-quality standards that drive success. Discover what sets our process apart and why our clients consistently achieve outstanding results.
Why Stable-Labeled Standards Are Crucial for Drug Development
Stable-labeled internal bioanalytical standards are molecules where certain atoms are replaced with heavier isotopes, such as deuterium (2H or D), 13C, and 15N. These non-radioactive isotopes retain the same physical and chemical properties as the original molecules but have a distinct molecular mass, making them ideal for mass spectral analysis. They are highly effective in correcting recovery rates, minimizing matrix effects, and reducing ionization variability during the extraction and analysis of analytes in complex matrices using LC-MS/MS.
In late-stage drug development (phases II and III), where accuracy is paramount, stable-labeled internal standards become especially critical. They provide significantly more reliable results compared to non-stable-labeled alternatives. While incorporating stable-labeled standards from phase I clinical trials is advisable, some clients choose to forego them initially. However, starting with stable-labeled standards from phase I ensures more accurate data throughout the development process. By the time phase II/III begins, using stable-labeled standards is essential for success.
Olon USA’s Unique Experience in Stable Labeling
With over 20 years of experience, Olon USA specializes in preparing complex stable-labeled compounds using deuterium, 13C, and 15N isotopes. As a CRO focused on early-phase drug development, for tox lots and GMP Phase I and II clinical lots, we utilize the chemistry and intermediates of unlabeled compounds to create cost-effective, high-isotopic purity stable-labeled bioanalytical standards. This ensures precise and reliable results throughout the drug development process.
We have extensive experience in ensuring the precise incorporation of labels, whether adding a typical +5 molecular weight unit or accurately positioning the label. Our expertise guarantees that we deliver stable, cost-effective, and reliable compounds meeting the rigorous standards required for drug development.
Criteria for a Suitable Stable-Labeled Bioanalytical Standard
While stable-labeled internal standards are the best choice, their effectiveness can be compromised if not properly selected. Even with stable isotopes, issues such as recovery effects and ionization variability can arise. Some standards may cause slight changes in analyte retention, leading to ion suppression and inaccurate results. To address these challenges, a well-designed bioanalytical internal standard is essential. Olon USA adheres to rigorous criteria to ensure optimal performance and reliability:
- High Isotopic Purity: The standard should have an isotopic purity of 99.9% or higher.
- Mass Unit Increase: A mass increase of +4 or preferably +5 units is recommended for common APIs. For APIs with elements like bromine or chlorine, a mass increase of +6 or +7 units may be required.
- Mass Increase: The required mass increase can be achieved through single or multiple stable-labeled atoms.
- Common Isotopes: The most frequently used stable-labeled atoms are deuterium, carbon-13, and nitrogen-15.
- Chemical Stability: The labeled atoms must remain chemically stable within the standard pH ranges used during analysis.
These criteria ensure that our stable-labeled bioanalytical standards provide accurate and reliable results.
Olon USA’s Proven Expertise in Labeling Services
Olon USA has achieved a 100% success rate in preparing custom stable-labeled compounds with 99.9% purity or higher. Contrary to the misconception that stable-labeled standards are prohibitively expensive, the stable-labeled standards are a very small fraction of the drug development cost and we often provide double the quantity at only 10% to 20% additional cost. We also offer comprehensive services, including storage, distribution, and stability testing for stable-labeled standards. Our extensive expertise ensures that we deliver successful, cost-effective, and timely solutions tailored to our clients’ needs.