Description

Hydroxy Cerivastatin, Sodium Salt is a high-purity pharmaceutical intermediate and reference standard, specifically the sodium salt of a key hydroxylated metabolite of the HMG-CoA reductase inhibitor Cerivastatin. This compound is of critical importance for research, analytical method development, and quality control in the pharmaceutical industry. It is primarily utilized by pharmaceutical R&D laboratories, contract research organizations (CROs), and manufacturers engaged in the synthesis and analysis of statin-based active pharmaceutical ingredients (APIs) and their related substances.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities and degradation products in Cerivastatin API and finished dosage forms.
• Metabolite Research: Serves as a critical standard in pharmacokinetic and metabolic studies to understand the biotransformation pathways of Cerivastatin.
• Analytical Method Development: Essential for developing and validating HPLC, LC-MS, and other chromatographic methods for impurity profiling and stability testing.
• Process Chemistry & Quality Control: Employed as a benchmark in the synthesis and purification processes to monitor and control the formation of specific process-related impurities.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing characterized material for impurity identification and qualification reports.

Basic Information

Product Name	Hydroxy Cerivastatin, Sodium Salt
CAS No.	189060-31-9
Molecular Formula	C26H33FNO5•Na
Molecular Weight	481.54 g/mol
Synonyms	Cerivastatin Hydroxy Metabolite Sodium Salt; (3R,5S,6E)-7-[4-(4-Fluorophenyl)-5-(methoxymethyl)-2,6-bis(1-methylethyl)-3-pyridinyl]-3,5-dihydroxy-6-heptenoic Acid Sodium Salt; Sodium (E,3R,5S)-7-[4-(4-fluorophenyl)-5-(methoxymethyl)-2,6-di(propan-2-yl)pyridin-3-yl]-3,5-dihydroxyhept-6-enoate; BAY w 6228 Metabolite; Rivastatin Hydroxy Metabolite Sodium Salt
EINECS	Contact for details

Quality Control

Our Hydroxy Cerivastatin, Sodium Salt is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and tests for residual solvents and heavy metals, to ensure it meets the stringent requirements for pharmaceutical reference standards. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting the batch-specific purity, identity, and impurity profile.

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 should be handled in a dry environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 2.0%
Residual Solvents (GC)	Complies with ICH guidelines
Heavy Metals	< 20 ppm

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