Description

Atorvastatin Impurity CAS NO 1357600-18-0 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Atorvastatin, a widely prescribed statin. It serves as an essential tool for analytical method development, validation, and regulatory compliance in pharmaceutical manufacturing. Quality control laboratories and R&D departments in the global pharmaceutical and biotechnology industries rely on such impurities for precise chromatographic analysis and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Atorvastatin calcium API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity levels throughout the drug product lifecycle.
• Quality Control & Assurance: Employed in routine batch release testing to ensure Atorvastatin drug substances and products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Used to identify and track degradation products formed under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Regulatory Submissions: Critical for preparing impurity profiles and supporting documentation for regulatory filings with agencies like the FDA, EMA, and PMDA.
• Research & Synthesis: Serves as a key intermediate or marker in process chemistry research to optimize synthesis pathways and minimize impurity formation.

Basic Information

Product Name	Atorvastatin Impurity
CAS No.	1357600-18-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atorvastatin Related Compound; Atorvastatin Impurity Standard; Atorvastatin EP Impurity; Atorvastatin USP Impurity; (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid impurity; Atorvastatin Degradation Product; Atorvastatin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Impurity CAS NO 1357600-18-0 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. The material is typically hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

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

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