Description

Bendamustine Impurity D is a specified impurity of the antineoplastic agent Bendamustine Hydrochloride, a critical component for ensuring the quality and safety of the active pharmaceutical ingredient (API). This compound is essential for pharmaceutical manufacturers and analytical laboratories engaged in method development, stability studies, and regulatory compliance testing. Its primary value lies in its use as a certified reference standard for the accurate identification, quantification, and control of impurities in Bendamustine drug substances and finished products, directly supporting the stringent requirements of pharmacopeial monographs and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods in quality control laboratories.
• Method Development and Validation: Critical for developing and validating analytical procedures for Bendamustine Hydrochloride API and related drug products.
• Stability and Degradation Studies: Used to monitor and quantify the formation of this specific impurity during forced degradation and long-term stability studies.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Pharmacopeial Testing: Employed to ensure Bendamustine batches comply with purity specifications outlined in USP, EP, or other pharmacopeias.
• Research and Development: Utilized in R&D to understand the degradation pathways and impurity profile of Bendamustine.

Basic Information

Item	Details
Product Name	Bendamustine Impurity D
CAS No.	191939-34-1
Molecular Formula	C₁₆H₂₁Cl₂N₃O₂
Molecular Weight	358.26 g/mol
Synonyms	Bendamustine Related Compound D; 5-{[(2-{4-[Bis(2-chloroethyl)amino]phenyl}-1H-benzimidazol-1-yl)carbonyl]amino}pentanoic Acid; 1-{[(5-Carboxypentyl)carbamoyl]}-2-[4-[bis(2-chloroethyl)amino]phenyl]-1H-benzimidazole; Bendamustine Impurity 4; Bendamustine Carboxylic Acid Impurity; UNII-6Q3S5J9Q2F
EINECS	Contact for details

Quality Control

Our Bendamustine Impurity D is manufactured under strict quality systems to ensure high purity and batch-to-batch consistency suitable for use as a reference standard. Each batch undergoes comprehensive analytical characterization using techniques such as HPLC, NMR, and MS to confirm identity and purity. A detailed Certificate of Analysis (COA) is provided with each shipment, containing full analytical data including assay, related substances, and residual solvents. Our quality commitment aligns with cGMP principles for pharmaceutical impurities and supports compliance with ICH Q3A/B guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term storage, consider storing at 2-8°C. Keep the container sealed to protect from moisture.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Any single unknown impurity	≤ 1.0%
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.