Description

Simvastatin Ammonium Salt is a key pharmaceutical intermediate derived from the well-known cholesterol-lowering agent, simvastatin. This compound is critical for ensuring the stability, solubility, and precise formulation of active pharmaceutical ingredients (APIs) in finished drug products. It is primarily utilized by pharmaceutical manufacturers and research institutions engaged in the development and production of cardiovascular medications and related therapeutic agents.

Application

• Primary intermediate in the synthesis of Simvastatin and related HMG-CoA reductase inhibitors.
• Critical raw material for the formulation of finished dosage forms (e.g., tablets, capsules) in cardiovascular therapy.
• Used in pharmaceutical research and development for creating new drug delivery systems.
• Reference standard in analytical laboratories for quality control and method validation (HPLC, LC-MS).
• Starting material for the preparation of other simvastatin derivatives and prodrugs.
• Essential component in GMP-compliant manufacturing processes for regulated markets.

Basic Information

Product Name	Simvastatin Ammonium Salt
CAS No.	139893-43-9
Molecular Formula	C25H39NO5 • NH3 (or C25H42N2O5)
Molecular Weight	~ 450.62 g/mol
Synonyms	Simvastatin Ammonium; Ammonium Simvastatin; Simvastatin NH4 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 (2S)-2-methylbutanoate ammonium salt; ZOCOR Ammonium Salt; MK 733 Ammonium Salt
EINECS	Contact for details

Quality Control

Our Simvastatin Ammonium Salt is produced under strict quality management systems. It undergoes rigorous analytical testing to ensure compliance with pharmaceutical-grade standards, including identity, purity, and impurity profile verification. A comprehensive Certificate of Analysis (COA) is provided with each batch, detailing results from tests such as HPLC assay, related substances, residual solvents, and specific rotation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which can affect stability and potency. Long-term storage under inert atmosphere (e.g., nitrogen) is recommended.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	≥ 98.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Specific Rotation	Contact for details

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