Shenzhen Excellent Biomedical Technology Co.,Ltd.(SZEB) is a leading supplier of high quality pharmaceutical impurities,API related compounds,intermediates,labeled standards and impurity custom synthesis services.E-mail:sales@ex-biotech.com.
Discover all our products through our official website (https://www.ex-biotech.com/), and get in touch if you have any questions about how we can help support your work. Email:sale@ex-biotech.com.
*The following content is generated by AI and is for reference only.
Overview
Ampicillin EP Impurity M Disodium Salt is a defined degradation product of the broad-spectrum beta-lactam antibiotic, typically formed via dimerization. It serves as a critical reference standard for HPLC purity analysis in pharmaceutical manufacturing to ensure compliance with European Pharmacopoeia (EP) specifications regarding diastereomeric impurities. The material represents a mixture of diastereomers resulting from the coupling of ampicillin units.
Application
- Quality Control: Used as an analytical standard for method validation and system suitability testing in API production.
- R&D: Employed in stability-indicating studies to monitor degradation pathways during formulation development.
- Regulatory Compliance: Essential for generating data required by FDA and EMA dossiers on specific impurity profiles.
Precautions
Store under inert atmosphere at controlled temperatures below 25°C to prevent hydrolysis. Personnel must utilize appropriate PPE due to potential sensitization risks associated with beta-lactam compounds. This substance is strictly for laboratory research and quality control use only, not for clinical administration.