Description

(2S,4S,5S,7R)-Aliskiren Fumarate (2:1) is a high-purity, non-peptide renin inhibitor salt form, specifically designed for advanced pharmaceutical research and development. This compound is critical for developing next-generation antihypertensive therapies targeting the renin-angiotensin-aldosterone system (RAAS). It is primarily required by pharmaceutical companies, contract research organizations (CROs), and academic institutions engaged in cardiovascular drug discovery, process chemistry, and analytical method development.

Application

• Pharmaceutical Reference Standard: Serves as a primary chemical reference material (CRM) for quality control and analytical method validation in drug manufacturing.
• Active Pharmaceutical Ingredient (API) Intermediate: Used in the synthesis and scale-up of Aliskiren-based final dosage forms.
• Preclinical & Clinical Research: Essential for pharmacological studies, pharmacokinetic profiling, and toxicology assessments in drug development pipelines.
• Process Development & Optimization: Employed in route scouting, impurity profiling, and crystallization studies to optimize manufacturing processes.
• Analytical Testing: Utilized as a system suitability standard in HPLC, UPLC, and LC-MS methods for assay and related substance testing.

Basic Information

Product Name	(2S,4S,5S,7R)-Aliskiren Fumarate (2:1)
CAS No.	1630036-82-6
Molecular Formula	C64H104N8O16
Molecular Weight	1241.55 g/mol
Synonyms	Aliskiren Fumarate (2:1) Salt; (2S,4S,5S,7R)-2,7-Di(1-methylethyl)-4-hydroxy-5-amino-8-[4-methoxy-3-(3-methoxypropoxy)phenyl]octanamide hemifumarate; SPP-100 Fumarate; CGP-60536B; Tekturna Fumarate; Rasilez Fumarate; Renin Inhibitor SPP100 Fumarate
EINECS	Contact for details

Quality Control

Our (2S,4S,5S,7R)-Aliskiren Fumarate (2:1) is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including chiral purity verification, to ensure compliance with pharmaceutical-grade standards. A detailed Certificate of Analysis (COA) providing identity, purity, and impurity profile data is supplied with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure containers are sealed immediately after use to prevent degradation from atmospheric moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time conforms to reference standard
Assay (HPLC)	≥98.0%
Chiral Purity (Chiral HPLC)	≥99.0%
Water Content (KF)	≤1.0%
Residue on Ignition	≤0.1%
Heavy Metals	≤20 ppm
Related Substances (HPLC)	Total impurities ≤2.0%; Any single impurity ≤0.5%

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