Description

Ranolazine Impurity 13 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the anti-anginal pharmaceutical agent, Ranolazine. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine quality control testing. The reliable identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the analysis of Ranolazine active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to separate and quantify impurities in Ranolazine.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity profiles and ensure batch-to-batch consistency of Ranolazine.
• Stability Studies: Used to identify and track degradation products formed during the forced degradation and long-term stability studies of Ranolazine.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and marketing authorization applications.
• Research & Development: Serves as a key material in pharmaceutical R&D for studying the synthesis pathway, degradation mechanisms, and metabolism of Ranolazine.

Basic Information

Product Name	Ranolazine Impurity 13
CAS No.	1983943-76-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ranolazine Related Compound 13; Ranolazine EP Impurity J; Ranolazine USP Impurity; Ranolazine Process Impurity; 1-Piperazineacetamide, N-(2,6-dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-, (2R,3R)-; (2R,3R)-N-(2,6-Dimethylphenyl)-4-[2-hydroxy-3-(2-methoxyphenoxy)propyl]-1-piperazineacetamide
EINECS	Contact for details

Quality Control

Every batch of Ranolazine Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, and NMR to ensure compliance with pharmacopeial standards (e.g., USP, EP). A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

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 the container with care to prevent moisture ingress and physical damage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Conforms to reference retention time
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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