Description

Atorvastatin Impurity 134 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) in cholesterol-lowering medications. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The use of this well-characterized impurity standard is essential for compliance with stringent pharmacopeial guidelines and regulatory submissions.

Application

• Pharmaceutical Quality Control (QC): Used as a certified reference material for the identification and quantification of specific impurities in Atorvastatin API and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Stability Studies: Employed to track the formation and level of this impurity during forced degradation and long-term stability testing of Atorvastatin formulations.
• Regulatory Compliance & Documentation: Essential for preparing regulatory filings (e.g., for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development (R&D): Used in synthetic chemistry R&D to study the formation pathways and chemical behavior of this specific impurity.
• Pharmacopeial Testing: Applied as a reference standard for testing against specifications in monographs from USP, EP, or other pharmacopeias.

Basic Information

Product Name	Atorvastatin Impurity 134
CAS No.	737755-14-5
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 J; Atorvastatin Related Compound J; Atorvastatin USP Related Compound J; Atorvastatin Impurity J; (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 134 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-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, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. Keep the container in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

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 unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.2%

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