Description

Ranolazine Dihydrochloride is a high-purity pharmaceutical intermediate and active pharmaceutical ingredient (API) primarily used in the development and manufacture of cardiovascular therapeutics. Its core value lies in its role as the dihydrochloride salt of Ranolazine, which offers enhanced stability and solubility for formulation. This compound is critically needed by pharmaceutical manufacturers, R&D laboratories, and contract development and manufacturing organizations (CDMOs) focused on producing anti-anginal medications. Ranolazine Dihydrochloride CAS NO 95635-56-6 is supplied under stringent quality control to ensure batch-to-batch consistency for regulatory filings and commercial production.

Application

• Pharmaceutical API Synthesis: Primary use as the active ingredient in the manufacture of finished dosage forms for the treatment of chronic angina.
• Cardiovascular Drug Development: Critical raw material in R&D for novel anti-ischemic and metabolic modulator therapies.
• Reference Standard: Serves as a high-purity standard for analytical method development, validation, and quality control testing in regulatory laboratories.
• Formulation Research: Used in pre-formulation and formulation studies to optimize stability, bioavailability, and release profiles of solid and liquid dosage forms.
• Generic Drug Manufacturing: Essential for companies producing bioequivalent generic versions of branded ranolazine medications.
• Clinical Trial Material (CTM) Production: Supplied under GMP guidelines for the production of batches used in Phase I-III clinical studies.

Basic Information

Product Name	Ranolazine Dihydrochloride
CAS No.	95635-56-6
Molecular Formula	C24H33N3O4·2HCl
Molecular Weight	500.46 g/mol (as dihydrochloride)
Synonyms	Ranolazine HCl; (±)-Ranolazine Dihydrochloride; RS-43285-003; CVT 303; 1-Piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, dihydrochloride; (R,S)-Ranolazine Dihydrochloride; N-(2,6-Dimethylphenyl)-2-[4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]piperazin-1-yl]acetamide dihydrochloride
EINECS	Contact for details

Quality Control

Our Ranolazine Dihydrochloride is manufactured and tested to meet the exacting standards required for pharmaceutical applications. Quality assurance protocols align with ICH guidelines and current Good Manufacturing Practices (cGMP). Each batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles. We can supply material that complies with relevant pharmacopeial monographs (e.g., USP) upon request, ensuring regulatory readiness for our global clientele.

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 product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Optical Rotation	Contact for details

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