Description

Simufilam Dihydrochloride is a high-purity, small molecule pharmaceutical compound of significant interest in advanced therapeutic research. Its primary value lies in its targeted mechanism of action, making it a critical intermediate and reference standard for drug discovery and development programs. This product is essential for pharmaceutical R&D laboratories, academic research institutions, and contract manufacturing organizations (CMOs) focused on developing novel treatments for complex neurological conditions.

Application

• Pharmaceutical Reference Standard: Used as a certified standard for analytical method development, validation, and quality control in API manufacturing.
• Preclinical & Clinical Research: Serves as a key active pharmaceutical ingredient (API) in formulation studies, pharmacokinetic/pharmacodynamic (PK/PD) modeling, and efficacy testing.
• Mechanistic Studies: Employed in biochemical and cellular assays to investigate specific biological pathways and protein interactions relevant to its therapeutic target.
• Process Chemistry & Scale-Up: Acts as a critical intermediate for process optimization, impurity profiling, and the synthesis of derivative compounds.
• Regulatory Submissions: Provides essential material for stability testing, batch analysis, and documentation required for regulatory filings (e.g., IND, NDA).

Basic Information

Item	Detail
Product Name	Simufilam Dihydrochloride
CAS No.	2480226-06-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Simufilam HCl; Simufilam dihydrochloride salt; (R)-5-((2-(4-(2-Fluorophenyl)piperazin-1-yl)ethyl)amino)-5-oxopentyl 4-methylbenzenesulfonate dihydrochloride; PTI-125 Dihydrochloride; FPL-12495 Dihydrochloride; Simufilam (dihydrochloride); CAS 2480226-06-8
EINECS	Contact for details

Quality Control

Our Simufilam Dihydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, residual solvent analysis, and identity confirmation (IR, MS) to ensure it meets the stringent requirements for pharmaceutical research. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting compliance with specified purity criteria, typically ≥95% to ≥98% by HPLC.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC/MS)	Conforms
Purity (HPLC)	≥95.0%
Water Content (KF)	≤5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	<20 ppm

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