Description

Bendamustine Impurity 29 is a designated process-related impurity and degradation product of the antineoplastic agent Bendamustine Hydrochloride. This compound is of critical importance in the pharmaceutical industry for analytical method development, stability studies, and ensuring the quality and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for research, quality control, and compliance purposes.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Bendamustine Impurity 29 in Bendamustine Hydrochloride drug substance and finished products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (HPLC, UPLC) to monitor impurities during drug manufacturing.
• Stability Studies & Forced Degradation: Employed in stability-indicating assays to understand the degradation pathways of Bendamustine and establish appropriate shelf-life and storage conditions.
• Quality Control & Batch Release: Serves as a system suitability standard and a comparator in the routine QC testing of active pharmaceutical ingredients (APIs) to ensure compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Regulatory Submissions: Critical for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research & Development: Used in R&D to study the chemical behavior, synthesis pathways, and toxicological profile of Bendamustine-related substances.

Basic Information

Product Name	Bendamustine Impurity 29
CAS No.	847588-86-7
Molecular Formula	C16H21Cl2N3O2
Molecular Weight	358.26 g/mol
Synonyms	1H-Benzimidazole-2-butanoic acid, 5-[bis(2-chloroethyl)amino]-1-methyl-, ethyl ester; Ethyl 5-[bis(2-chloroethyl)amino]-1-methyl-1H-benzimidazole-2-butanoate; Bendamustine Ethyl Ester Impurity; Bendamustine Related Compound 29; SDX-105 Impurity; Treanda Impurity; Ribomustin Impurity; UNII-4X6P2S2P4F
EINECS	Contact for details

Quality Control

Our Bendamustine Impurity 29 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical impurity analysis. Certificates of Analysis (COA) with detailed chromatographic data are provided, supporting compliance with ICH Q3A (R2) and ICH Q6A guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. For long-term storage, consider storing at 2-8°C. Handle and store under an inert atmosphere if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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