Description

Atorvastatin Calcium Hydrate Impurity 33 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of Atorvastatin Calcium, a widely prescribed cholesterol-lowering medication. It serves as a key analytical marker for pharmaceutical manufacturers and quality control laboratories engaged in method development, validation, and impurity profiling. Professionals in the pharmaceutical and analytical chemistry sectors rely on this standard to meet stringent regulatory requirements for drug substance and product characterization.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in Atorvastatin Calcium active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity levels throughout the drug product lifecycle.
• Quality Control & Assurance (QC/QA): Employed as a system suitability standard and for preparing calibration curves to ensure the accuracy and precision of impurity assays in compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive characterization data for specified impurities, aiding in the drug approval process.
• Stability Studies: Acts as a reference to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and long-term stability testing.
• Research & Development: Utilized in synthetic chemistry R&D to study impurity formation pathways and to optimize manufacturing processes to minimize related substances.

Basic Information

Product Name	Atorvastatin Calcium Hydrate Impurity 33
CAS No.	2299304-89-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Atorvastatin Related Compound 33; Atorvastatin Impurity 33; Atorvastatin Calcium Impurity 33; Atorvastatin EP Impurity C; Atorvastatin USP Related Compound; (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-3,5-dihydroxyheptanoic Acid Calcium Salt Impurity; Atorvastatin Calcium Hydrate Specified Impurity
EINECS	Contact for details

Quality Control

Our Atorvastatin Calcium Hydrate Impurity 33 is manufactured and handled under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural elucidation via spectroscopic methods (NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to primary reference standards where applicable. Our quality commitment aligns with the principles of current Good Manufacturing Practice (cGMP) for APIs and excipients.

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 must be kept in a desiccated environment to maintain stability and purity. Avoid prolonged exposure to high humidity.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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