Description

Atorvastatin Lactam Impurity CAS NO 906552-18-9 is a key process-related impurity and degradation product formed during the synthesis and storage of Atorvastatin, a leading statin medication. This compound is critical for pharmaceutical research and development, serving as a certified reference standard for method validation, stability studies, and ensuring drug purity and safety. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory compliance teams involved in quality control and the development of generic Atorvastatin formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of lactam-related impurities in Atorvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Method Development and Validation (HPLC/LC-MS): Essential for developing and validating robust analytical methods to monitor and control impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of Atorvastatin and to establish appropriate storage conditions and shelf-life.
• Quality Control and Batch Release: A critical component in the quality control workflow to ensure that Atorvastatin batches meet stringent pharmacopeial specifications (USP, EP, BP).
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Abbreviated New Drug Applications (ANDAs), and other regulatory documentation.
• Research and Development: Used in synthetic chemistry research to study impurity formation mechanisms and to develop improved, cleaner synthetic routes for Atorvastatin.

Basic Information

Product Name	Atorvastatin Lactam Impurity
CAS No.	906552-18-9
Molecular Formula	C33H35FN2O5
Molecular Weight	582.65 g/mol
Synonyms	Atorvastatin Lactam; (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic acid δ-lactam; Atorvastatin EP Impurity D; Atorvastatin USP Impurity D; Atorvastatin Related Compound D; 1H-Pyrrole-1-heptanoic acid, 2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-, δ-lactam, (βR,δR)-; UNII-0B6Q1N5N1P
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Lactam Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards (USP, EP) and ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

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 material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
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 single unknown 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.