Description

Atorvastatin Impurity 16 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 Atorvastatin, a leading cholesterol-lowering medication. It is primarily required by pharmaceutical manufacturers and analytical laboratories for method development, validation, and routine quality control testing. The availability of this well-characterized impurity is essential for maintaining stringent pharmacopeial standards in drug production.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Atorvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles during API synthesis and formulation.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC labs to ensure analytical procedures are performing correctly for impurity detection.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions, supporting drug shelf-life determination.
• Process Chemistry Research: Used by R&D scientists to study and optimize synthetic pathways to minimize the formation of this impurity.

Basic Information

Item	Details
Product Name	Atorvastatin Impurity 16
CAS No.	1450739-65-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid; Atorvastatin EP Impurity J; Atorvastatin Related Compound J; Atorvastatin Carbamate Impurity; Atorvastatin Impurity J (EP); Atorvastatin 1H-Pyrrole-4-carboxamide Impurity
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Impurity 16 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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