Description

3”-Hydroxy Simvastatin CAS NO 126313-98-2 is a key pharmaceutical intermediate and metabolite of the cholesterol-lowering drug Simvastatin. This compound is critical for research and development in the pharmaceutical industry, particularly for metabolic studies, impurity profiling, and the synthesis of novel active pharmaceutical ingredients (APIs). It is primarily utilized by pharmaceutical manufacturers, contract research organizations (CROs), and academic research institutions focused on cardiovascular drug development and analytical method validation.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis and development of statin-based cholesterol-lowering medications.
• Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Simvastatin and its related substances in quality control laboratories.
• Metabolite Studies: Essential for in-vitro and in-vivo pharmacokinetic and pharmacodynamic research to understand the metabolic pathway of Simvastatin.
• Impurity Profiling: Serves as a known impurity standard to ensure the purity and safety of Simvastatin API batches according to ICH guidelines.
• Analytical Method Development: Used to validate HPLC, UPLC, and LC-MS/MS methods for accurate assay and impurity testing.
• Research Chemical: Employed in academic and institutional research for studying HMG-CoA reductase inhibition mechanisms.

Basic Information

Product Name	3”-Hydroxy Simvastatin
CAS No.	126313-98-2
Molecular Formula	C25H38O6
Molecular Weight	434.57 g/mol
Synonyms	3''-Hydroxy Simvastatin; Simvastatin Hydroxy Acid; 3-Hydroxy Simvastatin; (3R,5R)-7-((1S,2S,6R,8S,8aR)-8-((2R,4R)-4-Hydroxy-6-oxotetrahydro-2H-pyran-2-yl)-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)-3,5-dihydroxyheptanoic Acid; L-654,969; Simvastatin β-Hydroxy Acid; Zocor Hydroxy Acid; MK 0733 Acid Form
EINECS	Contact for details

Quality Control

Our 3”-Hydroxy Simvastatin is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation via IR and NMR, to ensure it meets high-purity standards suitable for pharmaceutical research and development. Certificates of Analysis (COA) with detailed chromatographic data are provided for every shipment.

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 must be kept in a dry environment. 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
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single 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.