Description

Atorvastatin Lactam Phenanthrene Calcium Salt Impurity 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 Atorvastatin, a leading cholesterol-lowering medication. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development, quality control, and method validation. The availability of this well-characterized impurity is essential for accurate HPLC/LC-MS analysis and for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify this specific impurity in Atorvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating chromatographic methods (HPLC, UPLC, LC-MS) to ensure specificity and accuracy.
• Quality Control and Stability Testing: Employed in routine QC testing and forced degradation studies to monitor impurity levels and ensure product stability and shelf-life.
• Regulatory Compliance and Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA, ICH) to demonstrate thorough impurity characterization and control strategies.
• Research and Development: Used in pharmacokinetic and metabolic studies to understand the formation and behavior of this impurity.
• Calibration of Laboratory Equipment: Acts as a precise calibrant for analytical instruments to maintain data integrity and traceability.

Basic Information

Product Name	Atorvastatin Lactam Phenanthrene Calcium Salt Impurity
CAS No.	148127-12-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atorvastatin Lactam Phenanthrene Derivative; Atorvastatin EP Impurity G (Calcium Salt); (3R,5R)-7-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-(phenylcarbamoyl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid Lactam Phenanthrene Calcium Salt; Atorvastatin Related Compound G; Calcium (3R,5R)-7-[2-(4-fluorophenyl)-5-isopropyl-3-phenyl-4-(phenylcarbamoyl)pyrrol-1-yl]-3,5-dihydroxyheptanoate Lactam Phenanthrene Derivative
EINECS	Contact for details

Quality Control

Every batch of Atorvastatin Lactam Phenanthrene Calcium Salt 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, ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%
Heavy Metals	≤ 20 ppm

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