Halogenated Butyl Rubber Oligomers – Vitnvivo
Ensuring the safety and efficacy of pharmaceutical products is paramount, and a critical aspect of this is monitoring potential leachables from packaging materials. Halogenated butyl rubber, commonly used in pharmaceutical stoppers and seals, can release specific oligomers into drug products, potentially affecting their quality. Accurate detection and quantification of these oligomers are essential, necessitating reliable reference standards.
Vit-n-Vivo: Pioneering Rubber Oligomer Reference Standards
Recognizing the industry’s need for precise analytical tools, Vit-n-Vivo has successfully isolated and now offers a range of rubber oligomer reference materials. These standards include:
- C13H23Cl Rubber Oligomer (RI 1418, CAS: 63216-72-8)
- C13H23Br Rubber Oligomer (RI 1501, CAS: 2514965-51-4)
- C21H39Br Rubber Oligomer (RI 2035, CAS: 2518227-14-8)
- A mixture of C21H39Br Rubber Oligomers (RI 1985 and 1990)
- C21H40 Rubber Oligomer (RI 1712, CAS: 2512216-71-4)
These authentic reference standards are indispensable for laboratories aiming to accurately identify and quantify rubber oligomers in pharmaceutical products. Utilizing these standards enhances the precision of analytical methods, ensuring that any leachables present are detected reliably.
Why Monitoring Halogenated Butyl Rubber Oligomers Matters
Halogenated butyl rubber oligomers, such as C13H23Cl, C13H23Br, and C21H39Br, can migrate into drug products from packaging materials. Their presence poses two primary concerns:
- Potential Mutagenicity: These compounds belong to the class of aliphatic halogens, which are alkylating agents capable of damaging DNA, raising concerns about their carcinogenicity and mutagenicity.
- Reactivity with Active Pharmaceutical Ingredients (APIs): The oligomers can react with nucleophilic centers in API molecules, potentially reducing drug efficacy and generating impurities. For instance, studies have shown that C13H23Br can react with lyophilized insulin, underscoring the importance of monitoring these leachables.
Enhancing Analytical Precision with Vit-n-Vivo’s Mass Spectral Library
To assist laboratories in identifying these oligomers, Vit-n-Vivo provides a mass spectral library of rubber oligomers. This resource enables analysts to match deconvoluted spectra with known standards, facilitating accurate identification of leachables in samples.
Commitment to Pharmaceutical Safety
Vit-n-Vivo’s dedication to providing high-quality reference standards and analytical resources underscores their commitment to pharmaceutical safety. By equipping laboratories with the tools needed to detect and quantify rubber oligomers, they play a crucial role in ensuring that pharmaceutical products remain safe and effective for consumers.
For more information on Vit-n-Vivo’s offerings and to access their mass spectral library, visit their website.
Halogenated Butyl Rubber Oligomers – Vitnvivo
Note: Always ensure compliance with relevant regulatory guidelines when conducting extractables and leachables studies.
