Description

Cistracurium Besylate Ep Impurity D is a high-purity reference standard and pharmaceutical impurity used in analytical research and quality control. This compound is critical for ensuring the safety and efficacy of the neuromuscular blocking agent, Cistracurium Besylate, by enabling precise identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specified impurities in Cistracurium Besylate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor process-related impurities.
• Quality Control & Assurance (QC/QA): Essential for routine batch release testing in pharmaceutical manufacturing to ensure compliance with pharmacopeial standards (e.g., EP, USP).
• Stability Studies: Employed to track the formation of degradation products in Cistracurium Besylate formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in synthetic chemistry research to understand degradation pathways and to improve the purity of the final API.

Basic Information

Product Name	Cistracurium Besylate Ep Impurity D
CAS No.	1075726-88-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	1R-cis,1'R-cis-2,2'-[1,5-Pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] Dibenzenesulfonate; Cistracurium Besylate Related Compound D; Cistracurium Impurity D; Cistracurium Besylate EP Impurity D; (1R-cis)-2,2'-[1,5-Pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] Dibenzenesulfonate; Cistracurium Bisbenzene sulfonate Impurity D
EINECS	Contact for details

Quality Control

Every batch of Cistracurium Besylate Ep Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, LC-MS) and spectroscopic techniques to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and residual solvents.

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. The container should be kept in a dry, cool, and well-ventilated area. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to 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 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.