Description

Rizatriptan Dimer Benzoate is a high-purity pharmaceutical intermediate and reference standard of significant importance in modern drug development and quality control. Its primary value lies in its critical role as a key impurity marker and synthetic precursor for the active pharmaceutical ingredient (API) Rizatriptan Benzoate, a leading medication for acute migraine treatment. This compound is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on ensuring the purity, safety, and efficacy of migraine therapeutics through rigorous impurity profiling and method validation.

Application

• Pharmaceutical Impurity Standard: Serves as a certified reference material (CRM) for the identification, qualification, and quantification of the dimer impurity in Rizatriptan Benzoate API and finished dosage forms.
• Analytical Method Development: Used in the development and validation of stability-indicating HPLC, UPLC, and LC-MS methods for impurity profiling in compliance with ICH guidelines.
• Process Chemistry Research: Employed as a critical intermediate in synthetic pathway studies to understand and control dimer formation during the manufacturing of Rizatriptan Benzoate.
• Quality Assurance & Control (QA/QC): Integral for routine batch release testing in pharmaceutical production to ensure API purity meets pharmacopeial specifications (e.g., USP, EP).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies to monitor impurity levels over the product's shelf life.

Basic Information

Product Name	Rizatriptan Dimer Benzoate
CAS No.	1016900-25-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rizatriptan Dimer; Rizatriptan Related Compound D; Rizatriptan Benzoate Dimer; 1H-Indole-3-ethanamine, N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-, Benzoate (2:1) (Dimer Form); Rizatriptan Impurity D; MK-0462 Dimer Benzoate
EINECS	Contact for details

Quality Control

Our Rizatriptan Dimer Benzoate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. Certificates of Analysis (COA) with detailed chromatographic data and traceable results are provided for every lot, supporting compliance with cGMP and ICH Q3A/B guidelines.

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 in a desiccated environment to maintain stability and purity. Handle and store under an inert atmosphere where specified.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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