Description

Aliskiren Hemifumarate is a high-purity active pharmaceutical ingredient (API) used as a direct renin inhibitor. This compound is critical for the research and development of antihypertensive medications, targeting the renin-angiotensin-aldosterone system (RAAS). It is primarily utilized by pharmaceutical manufacturers and research institutions in the development of novel cardiovascular therapies and generic drug formulations.

Application

• Pharmaceutical API: Primary active ingredient in the formulation of antihypertensive drugs.
• Reference Standard: Used as a certified reference material (CRM) in analytical laboratories for method development and validation.
• Biochemical Research: A key tool for studying the renin-angiotensin system and its role in cardiovascular physiology and pathology.
• Generic Drug Development: Essential for companies developing bioequivalent versions of aliskiren-based medications.
• Preclinical & Clinical Studies: Used in pharmacological and toxicological studies during drug development stages.
• Pharmaceutical Intermediates: Serves as a critical intermediate for further chemical synthesis in specialized drug formulations.

Basic Information

Product Name	Aliskiren Hemifumarate
CAS No.	173334-58-2
Molecular Formula	C30H53N3O6 • 0.5C4H4O4
Molecular Weight	609.8 g/mol
Synonyms	Aliskiren Fumarate; SPP-100 Hemifumarate; (2S,4S,5S,7S)-N-(2-Carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]octanamide hemifumarate; CGP 60536B; Tekturna API; Rasilez API; SPP100
EINECS	Contact for details

Quality Control

Our Aliskiren Hemifumarate is manufactured under strict quality systems. Each batch is tested to ensure it meets high-purity standards suitable for pharmaceutical applications, with specifications aligned with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profiles is provided with every shipment to ensure traceability and regulatory compliance.

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.

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% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Total impurities ≤ 1.0%; Any single impurity ≤ 0.5%
Heavy Metals	≤ 20 ppm

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