Description

Rosuvastatin Ep Impurity H is a high-purity chemical reference standard used in the pharmaceutical development and quality control of Rosuvastatin, a widely prescribed statin medication. This compound is critical for ensuring the safety and efficacy of the final drug product by enabling accurate identification, quantification, and control of specific impurities. It is an essential material for analytical chemists and quality assurance professionals in pharmaceutical R&D and manufacturing, particularly for those working under stringent regulatory frameworks like ICH guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of Rosuvastatin Ep Impurity H in active pharmaceutical ingredients (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating sensitive HPLC, UPLC, or LC-MS methods for impurity profiling.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to monitor impurity levels against strict ICH Q3A/B thresholds to ensure batch-to-batch consistency and compliance.
• Stability Studies: Employed to track the formation of this specific impurity over time under various stress conditions (e.g., heat, humidity, light) as part of drug stability programs.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity understanding and control strategies to agencies like the FDA and EMA.
• Pharmacopoeial Testing: Supports testing to meet the stringent purity criteria outlined in pharmacopoeial monographs such as USP, EP, or BP for Rosuvastatin.

Basic Information

Product Name	Rosuvastatin Ep Impurity H
CAS No.	1335110-44-5
Molecular Formula	C22H28FN3O6S
Molecular Weight	481.54 g/mol
Synonyms	Rosuvastatin Impurity H; (3R,5S)-7-[4-(4-Fluorophenyl)-6-(1-methylethyl)-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid; Rosuvastatin EP Impurity H; Rosuvastatin Related Compound H; (E)-7-[4-(4-Fluorophenyl)-6-isopropyl-2-[N-methyl(methylsulfonamido)]pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoic Acid
EINECS	Contact for details

Quality Control

Every batch of Rosuvastatin Ep Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, LC-MS, NMR) to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, including assay purity and related substance data.

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 must be kept under dry, inert conditions to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere such as argon or nitrogen.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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