Description

Atorvastatin Related Compound C is a high-purity chemical reference standard, essential for pharmaceutical research and quality control. This compound serves as a critical impurity marker in the analysis and validation of Atorvastatin, a leading cholesterol-lowering medication. It is primarily used by analytical chemists, quality assurance professionals, and R&D scientists in the pharmaceutical and fine chemical industries to ensure product purity, safety, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Atorvastatin Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: A critical component in developing, qualifying, and validating HPLC, UPLC, and other chromatographic methods for Atorvastatin.
• Quality Control (QC) Testing: Employed as a system suitability standard and for routine batch release testing in pharmaceutical manufacturing to meet pharmacopeial (USP, EP) specifications.
• Stability Studies: Used to monitor the formation of degradation products in Atorvastatin under various stress conditions (e.g., heat, light, humidity).
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing definitive impurity characterization data for health authorities like the FDA and EMA.
• Research & Development: Facilitates metabolic and pharmacokinetic studies by helping to trace and understand related substance pathways.

Basic Information

Product Name	Atorvastatin Related Compound C
CAS No.	693793-53-2
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 C; Atorvastatin USP Related Compound C; Atorvastatin Impurity C; Atorvastatin 4'-N-Phenylamide; (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

Our Atorvastatin Related Compound C is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high standards required for pharmaceutical reference materials. Each batch is characterized using advanced techniques including HPLC, NMR, and MS to confirm identity and purity. Certificates of Analysis (COA) with detailed chromatographic data are provided, supporting compliance with ICH guidelines and pharmacopeial 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 low-humidity environment to prevent degradation. For long-term storage, consider desiccated conditions.

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, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
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.