Description

Atorvastatin Related Compound D (20 Mg) (Epoxide Impurity, Or 3-(4-Fluorobenzoyl)-2-Isobutyryl-3-Phenyl-Oxirane-2- Carboxylic Acid Phenylamide) is a critical pharmaceutical reference standard and impurity used in the quality control of Atorvastatin, a leading statin medication. This compound is essential for ensuring the safety and efficacy of the final drug product by enabling the accurate identification and quantification of a key process-related impurity. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of the epoxide impurity in Atorvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop and validate sensitive HPLC, UPLC, or LC-MS methods for impurity profiling in accordance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release Testing: A critical component in the routine QC testing of Atorvastatin to ensure impurity levels remain within specified safety thresholds.
• Stability Studies: Employed to monitor the formation of this impurity over time under various stress conditions (e.g., heat, humidity, light) during drug product stability testing.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity control strategies to agencies like the FDA and EMA.
• Research & Development: Used in R&D to study the degradation pathways and chemistry of Atorvastatin, aiding in process optimization and impurity mitigation.

Basic Information

Product Name	Atorvastatin Related Compound D (20 Mg) (Epoxide Impurity, Or 3-(4-Fluorobenzoyl)-2-Isobutyryl-3-Phenyl-Oxirane-2- Carboxylic Acid Phenylamide)
CAS No.	148146-51-4
Molecular Formula	C28H26FNO4
Molecular Weight	459.51 g/mol
Synonyms	Atorvastatin Epoxide Impurity; Atorvastatin Impurity D; 3-(4-Fluorobenzoyl)-2-isobutyryl-3-phenyloxirane-2-carboxylic acid phenylamide; Atorvastatin Related Substance D; Atorvastatin EP Impurity D; (2R,3S)-3-(4-Fluorophenyl)-1-isopropyl-2-oxo-5-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-3-heptanoic acid epoxide; Atorvastatin Oxirane Impurity
EINECS	Contact for details

Quality Control

This high-purity reference material is manufactured under strict quality control conditions. Each batch is characterized and tested using advanced analytical techniques including HPLC, GC, NMR, and Mass Spectrometry to confirm identity and purity. A comprehensive Certificate of Analysis (CoA) is provided, detailing the results against stringent in-house specifications. Our quality system is designed to support GMP/GLP compliance for pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The product is light-sensitive (store away from light). Keep the container tightly sealed in a dry environment.

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%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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