Description

Rosuvastatin Related Compound 18 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 Rosuvastatin, a widely prescribed statin medication, by serving as a key impurity marker. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control processes. Our supply guarantees the reliability and consistency essential for meeting stringent global pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Rosuvastatin Calcium active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Serves as a critical standard for developing and validating HPLC, UPLC, and LC-MS methods to ensure accurate impurity detection limits.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to comply with ICH Q3A(R2) and Q3B(R2) guidelines on impurities.
• Regulatory Submissions: Supports the preparation of regulatory documentation for agencies like the US FDA, EMA, and PMDA by providing characterized impurity data.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation pathways in Rosuvastatin formulations.
• Research & Development: Used in synthetic chemistry R&D to study the formation, fate, and purge of process-related impurities.

Basic Information

Product Name	Rosuvastatin Related Compound 18
CAS No.	2124275-54-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Rosuvastatin Impurity 18; Rosuvastatin EP Impurity M; Rosuvastatin USP Related Compound 18; (3R,5S)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-(N-methylmethanesulfonamido)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic acid related compound; Rosuvastatin Specified Impurity M; Rosuvastatin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Rosuvastatin Related Compound 18 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Our quality system is designed to guarantee identity, purity, and strength, with testing typically aligned with pharmacopeial methodologies. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and identification. We support compliance with ICH, USP, and EP guidelines.

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 light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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