Ibandronate Sodium Impurity24 NEW

Product Information

Product Code：I024024

English Name：Ibandronate Sodium Impurity 24

English Alias：methyl 3-(methyl(pentan-2-yl)amino)propanoate

CAS No.：1154279-11-4

Molecular Formula：C₁₀H₂₁NO₂

Molecular Weight：187.28

Advantages

High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR (1H, 13C), HRMS, and elemental analysis, suitable for Ibandronate Sodium impurity analysis and quality control.

Stability Assurance：Stable for 36 months at -20℃ under light-protected, sealed storage; degradation rate <0.3% in methanol - water mixture within 6 months.

Applications

Quality Control Testing：Used for UPLC-MS/MS detection of Impurity 24 in Ibandronate Sodium API and formulations, controlling content to meet ICH Q3A standards (single impurity limit ≤0.1%).

Process Optimization Research：Monitors impurity formation during Ibandronate Sodium synthesis, reducing generation by >30% by adjusting esterification temperature (e.g., 50 - 60℃) and reaction time.

Method Validation：Serves as a standard for developing impurity detection methods, verifying UPLC resolution (≥3.0) and LOD (0.01 ng/mL).

Background Description

Research Status

Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid - acetonitrile gradient elution achieves separation within 6 minutes, with LOD of 0.005 ng/mL for trace impurity analysis.

Formation Mechanism：Formed by nucleophilic substitution of methyl 3-aminopropionate with 2-pentanone under formic acid catalysis; optimizing catalyst dosage and reaction pH inhibits side reactions.

Safety Evaluation：In vitro cytotoxicity shows IC₅₀ of 198.6 μM against MG-63 bone cells (Ibandronate Sodium IC₅₀=10.2 μM), with lower toxicity than the main drug but requiring strict content control. Long-term stability testing is ongoing to monitor degradation under high temperature and humidity conditions.