High-Quality Cilastatin Impurity 15 – Trusted Reference Material for Pharmaceutical Development & QC Labs
Why Choose Our Cilastatin Ammonium Salt?
(Also known as Cilastatin Impurity 15, CAS 877674-82-3)
Finetech Industry Limited specializes in supplying high-purity, fully characterized biochemical and pharmaceutical-grade compounds. Our Cilastatin Ammonium Salt—a recognized Cilastatin Impurity (Impurity 15)—is manufactured and tested under strict analytical standards to meet the needs of quality control labs, research organizations, and pharmaceutical manufacturers.
✨ Pharmaceutical-Grade Impurity Standard:
Cilastatin Ammonium Salt is an important process-related and degradation impurity of Cilastatin, essential for analytical method validation, impurity profiling, and stability studies.
🔬 Analytical Purity Guaranteed:
Each batch is verified at ≥98% purity (Finetech Catalog: FT-0779456), ensuring reliable performance in HPLC quantification, structural elucidation, and reference standard applications.
🌍 Reliable Global Supply:
We ensure consistent stock availability, rapid worldwide shipping, and complete documentation packages (COA, Specification Sheet, TDS), supporting both early-stage R&D and bulk production workflows.
Versatile Applications of Cilastatin Ammonium Salt (CAS 877674-82-3)
(Cilastatin Impurity 15)
As a key impurity associated with Cilastatin synthesis and degradation, this compound plays a critical role in pharmaceutical analysis, impurity research, and drug development.
1. Impurity Profiling & ICH Regulatory Compliance
Cilastatin Ammonium Salt is widely used in:
• Method development and HPLC/UPLC validation
• Identification of process-related impurities
• QC release testing and stability program controls
Featured Research:
Impurities such as Cilastatin Impurity 15 are essential for understanding Cilastatin’s degradation kinetics and maintaining regulatory compliance in generic drug development.
2. β-Lactam Antibiotic Metabolism & Stability Research
Although an impurity, Cilastatin Ammonium Salt also supports mechanistic studies related to:
• DPEP-1 (renal dehydropeptidase-I)–mediated hydrolysis
• β-lactam degradation pathways
• Carbapenem stability improvement strategies
• Metabolite identification and structure confirmation
Featured Research:
Cilastatin and its related impurities are central to studies examining carbapenem renal metabolism and stabilization strategies (Nicolau et al., Clin. Infect. Dis., 1996).
3. Pharmaceutical Development, Process Characterization & API Quality Control
This impurity standard is valuable for:
• API process optimization
• Structure–process correlation studies
• Long-term and accelerated stability monitoring
• Genotoxic and non-genotoxic impurity assessment
• Cilastatin formulation compatibility studies
Featured Research:
Impurity standards improve reliability in pharmaceutical dossier submissions and API release testing by enabling accurate quantification and risk assessment.
Ordering & Supply Information
Finetech Industry Limited provides research- and analytical-grade Cilastatin Ammonium Salt (Cilastatin Impurity 15) with high purity and consistent quality.
📧 Email: sales@finetechnology-ind.com
Catalog Number: FT-0779456
Molecular Formula: C₁₆H₂₉N₃O₅S
Molecular Weight: 375.48
Contact us for quotations, COA requests, impurity profiling support, or technical consultation.
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