Description

Atorvastatin Impurity 36 CAS NO 1624328-52-4 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 active pharmaceutical ingredient (API) Atorvastatin Calcium. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in method development, stability studies, and impurity profiling. The availability of this well-characterized impurity standard is fundamental for maintaining the stringent quality control required in modern pharmaceutical production.

Application

• Pharmaceutical Impurity Profiling and Identification in Atorvastatin Calcium API and finished dosage forms.
• Analytical Method Development and Validation for HPLC, UPLC, and LC-MS techniques.
• Stability Studies and Forced Degradation Studies to monitor impurity formation over time.
• Quality Control (QC) and Quality Assurance (QA) testing in GMP manufacturing environments.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA, EMA, and PMDA.
• Research and Development of Atorvastatin synthesis pathways and degradation mechanisms.
• Calibration of Analytical Equipment using certified reference materials.
• Teaching and Academic Research in pharmaceutical chemistry and analytical sciences.

Basic Information

Product Name	Atorvastatin Impurity 36
CAS No.	1624328-52-4
Molecular Formula	C33H35FN2O5
Molecular Weight	558.65 g/mol
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 G; Atorvastatin Related Compound G; Atorvastatin Impurity G (EP); Atorvastatin 4'-Chloro Analog Impurity; 1H-Pyrrole-1-heptanoic Acid Derivative
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Impurity 36 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards such as USP and EP. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profiles. We support our clients' regulatory needs with full traceability and documentation.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.