Description

Rosuvastatin Impurity 121 is a high-purity chemical reference standard used in the pharmaceutical development and manufacturing process. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Rosuvastatin Calcium. It serves as a key analytical marker for identification, quantification, and control of specific impurities during method validation and routine quality testing. This impurity standard is essential for research laboratories, analytical service providers, and pharmaceutical companies engaged in the production of cardiovascular medications.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify and quantify Rosuvastatin Impurity 121 in API and finished drug products.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control (QC) and Quality Assurance (QA): Employed in routine batch release testing to monitor impurity levels and ensure they remain within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing protocols.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate control over the manufacturing process and impurity profile.
• Research and Development (R&D): Facilitates studies on the synthesis pathway, degradation routes, and pharmacokinetics of Rosuvastatin and its related substances.

Basic Information

Product Name	Rosuvastatin Impurity 121
CAS No.	140164-51-8
Molecular Formula	C₂₂H₂₈FN₃O₆S
Molecular Weight	481.54 g/mol
Synonyms	Rosuvastatin Related Compound 121; (3R,5S)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]-5-pyrimidinyl]-3,5-dihydroxy-6(E)-heptenoic Acid; Rosuvastatin EP Impurity I; Rosuvastatin USP Related Compound 121; Rosuvastatin Acid; Bisnortrans-Rosuvastatin; ZD-4522 Acid; (E)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-[N-methyl-N-(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid
EINECS	Contact for details

Quality Control

Our Rosuvastatin Impurity 121 is manufactured under strict quality control conditions to meet the exacting standards of pharmaceutical reference materials. Each batch is characterized using advanced spectroscopic and chromatographic techniques, including NMR, MS, and HPLC. We provide comprehensive Certificates of Analysis (COA) detailing purity, identity, and impurity profiles, ensuring full traceability and compliance with current Good Manufacturing Practice (cGMP) principles and relevant pharmacopoeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. The material is hygroscopic (moisture-sensitive) and should be handled under anhydrous conditions to maintain stability and purity.

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 unspecified impurity ≤ 0.5%
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.