Description

Bendamustine Impurity A is a specified impurity and degradation product of the active pharmaceutical ingredient Bendamustine Hydrochloride. This compound is critical for pharmaceutical research, development, and quality control, serving as a reference standard for analytical method validation and impurity profiling. It is essential for manufacturers, contract research organizations (CROs), and regulatory bodies to ensure the purity, safety, and efficacy of Bendamustine-based chemotherapeutic formulations.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of Bendamustine impurities.
• Critical component in analytical method development and validation (HPLC, LC-MS) for Bendamustine Hydrochloride drug substance and finished products.
• Essential for stability studies and forced degradation studies to understand the degradation pathways of Bendamustine.
• Used in quality control (QC) laboratories to monitor and control impurity levels during API synthesis and drug product manufacturing.
• Supports regulatory submissions (e.g., ANDA, NDA) by providing necessary impurity data to comply with ICH Q3A(R2) and Q3B(R2) guidelines.
• Valuable for academic and pharmacological research investigating the metabolism and pharmacokinetics of Bendamustine.

Basic Information

Product Name	Bendamustine Impurity A
CAS No.	109882-26-0
Molecular Formula	C₁₆H₂₁Cl₂N₃O₂
Molecular Weight	358.26 g/mol
Synonyms	Bendamustine Related Compound A; 5-{[(2-{[(2-Chloroethyl)amino]carbonyl}oxy)ethyl]amino}-1-methyl-1H-benzimidazole-2-butanoic Acid; 1H-Benzimidazole-2-butanoic acid, 5-[2-[bis(2-chloroethyl)amino]-2-oxoethoxy]-1-methyl-; Bendamustine EP Impurity A; Bendamustine USP Impurity A; Bendamustine Degradant; Treanda Impurity A
EINECS	Contact for details

Quality Control

Every batch of Bendamustine Impurity A is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic techniques, to ensure compliance with pharmacopeial standards such as USP and EP. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support our clients' regulatory needs with full traceability and documentation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to prevent degradation upon exposure to atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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