Description

Simvastatin, Sodium Salt is the water-soluble sodium salt form of Simvastatin, a well-known HMG-CoA reductase inhibitor. This form offers enhanced solubility and stability, making it a critical active pharmaceutical ingredient (API) and a valuable intermediate in advanced pharmaceutical synthesis. It is primarily utilized by pharmaceutical manufacturers and research institutions for the development and production of cholesterol-lowering medications and related therapeutic agents.

Application

• Active Pharmaceutical Ingredient (API) for the formulation of cholesterol-lowering drugs.
• Pharmaceutical Intermediate in the synthesis of advanced statin-based therapeutics.
• Reference Standard for quality control and analytical testing in pharmaceutical laboratories.
• Biochemical Research for studying lipid metabolism, HMG-CoA reductase inhibition, and related pathways.
• Preclinical and Clinical Research for developing new dosage forms and drug delivery systems.

Basic Information

Product Name	Simvastatin, Sodium Salt
CAS No.	101314-97-0
Molecular Formula	C25H39NaO5
Molecular Weight	442.57 g/mol
Synonyms	Simvastatin Sodium; Sodium Simvastatin; Simvastatin Sodium Salt; MK 0733 Sodium Salt; (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 Sodium Salt; Zocor Sodium Salt; Synvinolin Sodium Salt
EINECS	Contact for details

Quality Control

Our Simvastatin, Sodium Salt is manufactured under strict quality systems to ensure it meets the rigorous standards required for pharmaceutical applications. We adhere to cGMP (current Good Manufacturing Practice) guidelines, and the product can be supplied to meet various pharmacopoeial specifications, including USP and EP monographs. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing purity, identity, and impurity profiles.

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
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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