Isotope Labeled Impurities
Product List
Isotope labeled impurities have become vital in pharmaceutical research and development providing valuable information on drug substance purity, which ensures complete safety of drugs. As a professional pharmaceutical compound service provider, BOC Sciences has rich experience in synthesizing and analyzing isotope labeled impurities. We provide labeled impurities standards of high quality and low price to all companies or institutions with R&D needs or quality control. We offer stock or custom labeled impurities standards that can be used as internal standards. All products come with comprehensive analytical data files and are of high chemical purity. In addition, we also provide custom isotope labeling service for various types of impurities. You can directly provide the impurity compounds to be labeled, or you can request the type of isotope to be labeled, the labeling site, and the isotope enrichment.
What are Impurities?
Impurities are undesired chemical constituents in active pharmaceutical ingredients or pharmaceutical formulations. Impurities have no therapeutic effect and may affect the stability and efficacy of the drug or affect the scientific management of the drug. Some impurities even have toxic side effects and damage human health. Impurities in drugs may come from various links such as drug production, storage, and sales. Impurities come from various sources and typically include starting materials, intermediates, by-products, degradation products, and the like. The existence of impurities not only affects the quality of drugs, but also reflects the problems existing in the process of production, storage and transportation. Therefore, impurity research is an important part of drug research and development.
Functions of Impurities
Impurities, as a general term, are undesirable because of their harmful effects. But at the same time they do play an important role in pharmaceutical research.
- Quality Control: Continuous monitoring of impurities to maintain consistency and safety in the production Specifications for pharmaceutical products.
- Stability Studies: Impurities enable the determination of stability and shelf-life of drug products.
- Regulatory Compliance: There are regulations by agencies like the FDA and EMA that specify permissible limits of impurities so identifying, isolating & quantifying them becomes critical for commercialization purposes.
What are Isotope Labeled Impurities?
In drug development, production, transportation, storage, etc., it is necessary to maintain the purity of the active ingredients of the drug, reduce the impurity content of the drug, and maximize the effectiveness and safety of the drug. Impurities standards can be used for the identification, inspection and content determination of impurities and related substances. The use of impurities standards brings time and cost savings to drug development. Isotope-labeled impurities standards contain one or more isotopic atoms in their molecules. Except for isotopic effects, the chemical properties of isotopically substituted impurities standards are generally unchanged. Thus, labeled impurities standards can participate in similar chemical reactions and are traceable.
Our Isotope Labeling Services for Impurities
BOC Sciences offers comprehensive isotope labeling services tailored to the specific needs of our clients. Our services include:
- Custom Synthesis: We provide custom synthesis of isotope labeled impurities with high isotopic purity and precise incorporation.
- Analytical Support: Our state-of-the-art analytical facilities ensure accurate characterization and quantification of labeled impurities.
- Regulatory Assistance: We offer support in compiling regulatory documentation, ensuring compliance with international standards.
Choosing Labels for Your Research
Choosing the right isotope label depends on the specific requirements of the study. Factors to consider include:
- Nature of the APIs : The chemical structure and properties of the API influence the choice of isotope.
- Analytical Techniques: Different isotopes are detectable by various analytical methods such as NMR, MS, and IR spectroscopy.
- Safety and Stability: The stability of the isotope under experimental conditions and its safety profile must be considered.
We mainly offer the following stable isotope labeling types.
For more types of impurities and isotopic labeling, please contact us directly.
Applications of Isotope Labeled Impurities
Isotope labeled impurities have wide-ranging applications in pharmaceutical research and development:
- Pharmacokinetic Studies: Formation of drugs inorganism and their distribution.
- Stability Testing: Assaying the stability of degradation pathways of drug substances.
- Method Development: Developing and validating analytical methods for impurity profiling.
- Toxicological Studies: Evaluation of safety and toxic profiles for impurities.
Why Choose BOC Sciences for the Synthesis of Isotope Labeled Impurities?
- Expertise and Experience: A group of professionals with more than two decades in the industry ensure unmatched quality and accuracy.
- Advanced Facilities: Our laboratories have facilities to carry out isotope labeling and analysis using the best technology followed in eth industry.
- Regulatory Compliance: Our products are made to the highest standard of regulatory compliance across global legislature.
- Custom Solutions: We are able to deliver custom tailored solutions by listening and working with our clients to assure a satisfactory outcome.
FAQ
1. What is the meaning of impurities?
Impurities are any substances within a drug product that are not the intended active pharmaceutical ingredient (API) or an excipient. They can arise during various stages of the drug production process.
2. What are examples of impurity?
Examples of impurities include process-related by-products, degradation products, residual solvents, and inorganic contaminants like residual metals or reagents.
3. What is the FDA impurity limit?
The FDA sets specific limits for impurities based on the type of impurity and the dosage of the drug product. These limits are detailed in guidelines such as the International Council for Harmonisation (ICH) Q3A and Q3B.
4. How to identify impurities?
Impurities are identified using advanced analytical techniques such as mass spectrometry (MS), nuclear magnetic resonance (NMR) spectroscopy, high-performance liquid chromatography (HPLC), and gas chromatography (GC).
5. Why is isotope labeling important?
Isotope labeling is important for tracing and quantifying impurities in pharmaceutical products. It provides detailed insights into the presence, behavior, and impact of impurities, aiding in quality control and regulatory compliance.
6. How to do isotopic labeling?
Isotopic labeling involves the incorporation of isotopic atoms into the molecular structure of the compound of interest. This can be achieved through chemical synthesis or biosynthetic methods, followed by rigorous purification and characterization to ensure the desired isotopic composition.
