Description

Rosuvastatin Impurity 122 is a high-purity chemical reference standard used in the analytical profiling of the cholesterol-lowering drug Rosuvastatin. This compound is critical for pharmaceutical research and development, enabling the identification, quantification, and control of related substances to ensure drug safety and efficacy. It is an essential material for quality control laboratories, regulatory affairs, and analytical scientists working on method development and validation for Rosuvastatin API and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for HPLC, LC-MS, and other chromatographic methods.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods for Rosuvastatin.
• Quality Control & Assurance: Used in routine QC testing of Rosuvastatin Active Pharmaceutical Ingredient (API) and finished drug products to monitor impurity levels against ICH guidelines.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and dossiers.
• Stability Studies: Employed to identify and track degradation products formed during forced degradation and long-term stability studies of Rosuvastatin.
• Research & Process Chemistry: Aids in understanding the synthesis pathway and impurity formation mechanisms during Rosuvastatin manufacturing.

Basic Information

Item	Detail
Product Name	Rosuvastatin Impurity 122
CAS No.	135999-58-5
Molecular Formula	C22H28FN3O6S
Molecular Weight	481.54 g/mol
Synonyms	Rosuvastatin Related Compound 122; (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 J; Rosuvastatin USP Related Compound C; Rosuvastatin Acid Impurity; (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

Every batch of Rosuvastatin Impurity 122 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
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.