Description

Bendamustine Impurity 8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the anticancer drug Bendamustine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions for impurity profiling, method development, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Bendamustine Hydrochloride API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating stability-indicating chromatographic methods to ensure drug purity and safety.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing necessary data for impurity identification and qualification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control (QC) Testing: Serves as a system suitability standard and for routine batch release testing in pharmaceutical QC laboratories to monitor impurity levels.
• Stability Studies: Employed in forced degradation and long-term stability studies of Bendamustine to understand degradation pathways and establish shelf-life.
• Research & Development: Used in academic and industrial R&D for studying the metabolism, pharmacokinetics, and degradation chemistry of Bendamustine.

Basic Information

Product Name	Bendamustine Impurity 8
CAS No.	1797881-48-1
Molecular Formula	C₁₆H₂₁Cl₂N₃O₂
Molecular Weight	358.26 g/mol
Synonyms	Bendamustine Related Compound 8; Bendamustine Impurity B; 5-[(1-{[(2-{[(2-Chloroethyl)amino]carbonyl}phenyl)amino]carbonyl}-1,2,3,4-tetrahydro-7-isoquinolinyl)carbonyl]-1H-benzimidazol-2-amine; Bendamustine dimer impurity; Bendamustine process impurity; Treanda Impurity 8; Levact Impurity 8; SDX-105 Impurity 8
EINECS	Contact for details

Quality Control

Our Bendamustine Impurity 8 is manufactured under strict quality systems to ensure the highest standards of purity and traceability. Each batch is rigorously tested using validated analytical methods (HPLC, LC-MS, NMR) to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the requirements for pharmaceutical reference standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled under dry conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.