Description

5'(S)-Hydroxy Simvastatin is a key pharmaceutical intermediate and metabolite of the cholesterol-lowering drug Simvastatin. Its primary value lies in research and development for studying metabolic pathways, pharmacokinetics, and for the synthesis of novel statin derivatives. This compound is essential for pharmaceutical R&D laboratories, analytical reference standard providers, and manufacturers engaged in advanced active pharmaceutical ingredient (API) development.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for analytical method development and validation in quality control laboratories.
• Metabolite Research: Critical for in-vitro and in-vivo studies investigating the metabolic profile, bioavailability, and efficacy of Simvastatin.
• Process Impurity Profiling: Employed to identify, quantify, and control related substances during the manufacturing of Simvastatin API.
• Bioanalytical Studies: Serves as a standard in LC-MS/MS and HPLC assays for quantifying Simvastatin and its metabolites in biological matrices.
• Chemical Synthesis Intermediate: Utilized as a building block in the research-scale synthesis of new statin analogs and prodrugs.
• Regulatory Compliance: Supports regulatory filings (e.g., FDA, EMA) by providing impurity and degradation product identification data.

Basic Information

Product Name	5'(S)-Hydroxy Simvastatin
CAS No.	149949-05-3
Molecular Formula	C25H38O6
Molecular Weight	434.57 g/mol
Synonyms	Simvastatin Hydroxy Acid; (1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-Hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-dimethylbutanoate; 3-Hydroxy Simvastatin; 5'-Hydroxy Simvastatin; Simvastatin β-Hydroxy Acid; Zocor Hydroxy Acid Metabolite
EINECS	Contact for details

Quality Control

Our 5'(S)-Hydroxy Simvastatin is produced and handled under strict quality management protocols. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the stringent requirements for research and reference standard applications. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the certificate of analysis. The material is light-sensitive and should be handled accordingly to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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