Description

Inclisiran Sodium is the sodium salt form of inclisiran, a chemically synthesized small interfering RNA (siRNA) therapeutic agent. This compound is a critical active pharmaceutical ingredient (API) designed to target and silence the production of PCSK9 protein in the liver, thereby significantly lowering low-density lipoprotein cholesterol (LDL-C) levels. It is primarily utilized by pharmaceutical manufacturers and advanced research institutions for the development and production of novel, long-acting lipid-lowering therapeutics. The product, identified as CAS NO 1639324-58-5, represents a breakthrough in RNA-based medicine, offering a unique mechanism of action for managing cardiovascular risk.

Application

• Active Pharmaceutical Ingredient (API): Primary use in the commercial formulation of long-acting injectable cholesterol-lowering drugs.
• Pharmaceutical R&D: Critical raw material for preclinical and clinical-stage research into siRNA therapeutics for cardiovascular and metabolic diseases.
• Drug Product Manufacturing: Serves as the key therapeutic component in the final drug product manufacturing process under GMP conditions.
• Bioconjugation Studies: Used in research to develop novel delivery systems, such as GalNAc-conjugated formulations for targeted liver delivery.
• Reference Standard: Acts as a high-purity chemical reference standard for analytical method development, validation, and quality control in laboratories.
• Process Development: Employed in scaling up and optimizing synthetic and purification processes for oligonucleotide APIs.

Basic Information

Product Name	Inclisiran Sodium
CAS No.	1639324-58-5
Molecular Formula	C529H664F13N171Na29O316P29S6
Molecular Weight	Contact for details
Synonyms	Inclisiran sodium salt; ALN-PCSsc sodium salt; ALN-60212 sodium; siRNA targeting PCSK9 (sodium salt); PCSK9 siRNA (sodium form); Leqvio® API (sodium salt); (2'R)-2'-deoxy-2'-fluoro-2'-methyl-P-thioate oligonucleotide sodium salt; 5'-C*C*A*u*a*G*A*G*u*u*C*A*c*u*G*G*A*A*A*C*A-3' (sodium salt) (*=2'-O-methyl, *=2'-fluoro, lower case=2'-deoxy-2'-fluoro, s=phosphorothioate)
EINECS	Contact for details

Quality Control

Our Inclisiran Sodium is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical testing to ensure identity, purity, potency, and consistency. We provide full traceability and support regulatory filings with detailed documentation. Certificates of Analysis (COA) are supplied, detailing results from tests including HPLC for purity and assay, capillary gel electrophoresis (CGE) for impurity profile, mass spectrometry for identity confirmation, and tests for residual solvents, endotoxins, and bioburden.

Storage

Preserve in a tightly closed container, protected from light. Store at -20°C or below in a dedicated freezer. This product is hygroscopic (moisture-sensitive). For long-term storage, desiccate and keep under an inert atmosphere. Allow the sealed container to reach room temperature before opening to prevent condensation and moisture ingress.

Specification

Item	Specification
Appearance	White to off-white solid or lyophilized powder
Identification (HPLC/MS)	Conforms to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC)	≥ 90.0% (Full-length product)
Related Substances (CGE/HPLC)	Total impurities: NMT 10.0% Any single impurity: NMT 3.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Endotoxin (LAL)	< 10 EU/mg
Bioburden	Meets Ph. Eur. 2.6.12

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