Description

Atorvastatin Impurity G CAS NO 887324-53-0 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Atorvastatin, a leading active pharmaceutical ingredient (API) used in cholesterol management. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The availability of a well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Atorvastatin API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and LC-MS methods in quality control laboratories.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing necessary impurity profiling data.
• Stability Studies: Employed to monitor the formation of degradation products in Atorvastatin under various stress conditions.
• Process Chemistry R&D: Used by research scientists to study and optimize synthetic pathways to minimize impurity formation.
• Pharmacopeial Testing: Applied in testing to meet the specifications of USP, EP, and other international pharmacopeias.

Basic Information

Product Name	Atorvastatin Impurity G
CAS No.	887324-53-0
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 USP Impurity G; Atorvastatin Related Compound G; (βR,δR)-2-(4-Fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic Acid
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Impurity G is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity determination and structural confirmation (NMR, MS), to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for identity, purity, and related substances.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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