Description

3’,5’-Dihydrodiol Simvastatin (Mixture Of Diastereomers) is a key pharmaceutical intermediate and metabolite of the widely used 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 chemistry.

Application

• Pharmaceutical Intermediate: A crucial building block in the synthesis and research of HMG-CoA reductase inhibitors and related compounds.
• Metabolite Reference Standard: Used as an analytical standard in bioanalytical studies to identify and quantify simvastatin metabolites in biological matrices.
• Impurity Standard: Essential for method development and validation in quality control laboratories to monitor and control process-related impurities in simvastatin API manufacturing.
• Pharmacological Research: Employed in in vitro and in vivo studies to investigate the metabolic pathways, pharmacokinetics, and pharmacodynamics of statin drugs.
• Chemical Synthesis: Serves as a starting material or intermediate for the preparation of novel simvastatin derivatives and analogs for structure-activity relationship (SAR) studies.

Basic Information

Product Name	3’,5’-Dihydrodiol Simvastatin (Mixture Of Diastereomers)
CAS No.	198818-02-9
Molecular Formula	C25H38O6
Molecular Weight	434.57 g/mol
Synonyms	Simvastatin 3',5'-Dihydrodiol; Simvastatin Dihydrodiol; 3',5'-Dihydroxysimvastatin; (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 (2S)-2-methylbutanoate (and diastereomers); Simvastatin metabolite M4; 3'alpha,5'-Dihydrodiol Simvastatin
EINECS	Contact for details

Quality Control

Our 3’,5’-Dihydrodiol Simvastatin is produced under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical research and development. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting batch-specific results for purity, identity, and related substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0% (sum of diastereomers)
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
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.