Description

Dihydroergocristine Mesilate Impurity 12 (Dihydroergocristine Mesilate EP Impurity L) is a high-purity chemical reference standard, specifically identified as an impurity of the pharmaceutical substance Dihydroergocristine Mesylate. This compound is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) to ensure the purity, safety, and efficacy of related drug products.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Dihydroergocristine Mesylate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing and validating stability-indicating HPLC or UPLC methods according to ICH guidelines.
• Quality Control and Release Testing: Employed in routine QC testing of API batches to monitor impurity levels and ensure compliance with pharmacopoeial specifications (e.g., EP, USP).
• Stability Studies: Used to track the formation and growth of this impurity during forced degradation and long-term stability studies of drug substances and products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity characterization and control strategies.
• Pharmacopoeial Testing: Acts as a reference standard for testing described in monographs of the European Pharmacopoeia (EP) and other international compendia.

Basic Information

Product Name	Dihydroergocristine Mesilate Impurity 12 (Dihydroergocristine Mesilate EP Impurity L)
CAS No.	84094-91-7
Molecular Formula	C36H43N5O7S
Molecular Weight	689.83 g/mol
Synonyms	Dihydroergocristine Mesylate Impurity 12; Dihydroergocristine Mesylate EP Impurity L; Dihydroergocristine Methanesulfonate Impurity 12; (6aR,9R,10aR)-N-[(2R,5S,10aS,10bS)-5-Benzyl-10b-hydroxy-2-(1-methylethyl)-3,6-dioxooctahydro-8H-oxazolo[3,2-a]pyrrolo[2,1-c]pyrazin-2-yl]-7-methyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinoline-9-carboxamide methanesulfonate; Ergoloid Mesylates Impurity; CAS 84094-91-7
EINECS	Contact for details

Quality Control

Every batch of Dihydroergocristine Mesilate Impurity 12 is produced and analyzed under strict quality management systems. The material undergoes comprehensive testing, including HPLC purity assay, identity confirmation (IR, MS), and related substance analysis, to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (CoA) detailing all test results, methods, and traceability is provided with each shipment.

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. Keep the container in a dry, cool, and well-ventilated area. This product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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