Description

Atorvastatin Lactam Sodium Salt Impurity is a key chemical reference standard used in the pharmaceutical development and quality control of Atorvastatin, a widely prescribed statin medication. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of the lactam-related impurity in Atorvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor and control impurity levels, ensuring compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of degradation products in Atorvastatin formulations under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Investigational New Drug (IND) applications, and New Drug Applications (NDAs) to meet FDA, EMA, and other global regulatory requirements.
• Research & Development (R&D): Facilitates process chemistry research to understand and minimize impurity formation during Atorvastatin synthesis.

Basic Information

Product Name	Atorvastatin Lactam Sodium Salt Impurity
CAS No.	148217-40-7
Molecular Formula	C33H33FN2NaO5
Molecular Weight	579.62 g/mol
Synonyms	Atorvastatin Lactam Sodium Salt; Atorvastatin EP Impurity G (Sodium Salt); (3R,5R)-7-[3-(Anilinocarbonyl)-5-(4-fluorophenyl)-2-isopropyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid Lactam Sodium Salt; Atorvastatin Sodium Lactam; Atorvastatin Related Compound G Sodium Salt; 1H-Pyrrole-1-heptanoic acid, 3,5-dihydroxy-7-[3-(phenylcarbamoyl)-5-(4-fluorophenyl)-2-(1-methylethyl)-4-(phenylamino)carbonyl]-, γ-lactam, sodium salt
EINECS	Contact for details

Quality Control

Our Atorvastatin Lactam Sodium Salt Impurity is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) with detailed chromatographic data are provided and can be tailored to support compliance with USP, EP, ICH, and customer-specific 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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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