Description

Ranolazine Bis(n-Oxide) is a key pharmaceutical intermediate and metabolite of the antianginal drug Ranolazine. This compound matters for its critical role in the synthesis and analytical profiling of the active pharmaceutical ingredient, ensuring drug quality and consistency. It is primarily needed by pharmaceutical manufacturers and research institutions engaged in cardiovascular drug development, process chemistry, and metabolite studies. CAS No. 1246816-00-1.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis of Ranolazine and related therapeutic compounds.
• Reference Standard: Used as a certified reference material (CRM) for analytical method development and validation in quality control laboratories.
• Metabolite Studies: Essential for pharmacokinetic and pharmacodynamic research to understand the drug's metabolism and activity.
• Process Impurity Profiling: Employed to identify, quantify, and control related substances during API manufacturing.
• Regulatory Submissions: Serves as a characterized material for inclusion in drug master files (DMF) and regulatory dossiers (e.g., for FDA, EMA).
• Academic & Contract Research: Utilized in life science research for studying cardiac ion channels and ischemia mechanisms.

Basic Information

Item	Detail
Product Name	Ranolazine Bis(n-Oxide)
CAS No.	1246816-00-1
Molecular Formula	C24H33N3O5
Molecular Weight	443.54 g/mol
Synonyms	Ranolazine N,N-Dioxide; Ranolazine Dioxide; 1-[3-(2-Methoxyphenoxy)propyl]-4-[(2,6-dimethylphenyl)aminocarbonylmethyl]piperazine N,N'-Dioxide; CVT 303; RS 43285-003; RS-43285-003; Gilead-303
EINECS	Contact for details

Quality Control

Our Ranolazine Bis(n-Oxide) is manufactured under strict quality systems to meet the exacting standards of the pharmaceutical industry. Each batch undergoes comprehensive analytical testing, including HPLC for purity and related substances, IR and NMR for structural confirmation, and residual solvent analysis. A detailed Certificate of Analysis (COA) is provided with every shipment, ensuring full traceability and compliance with cGMP principles where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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