Description

Ledipasvir (D-Tartrate) CAS NO 1499193-68-8 is a high-purity, non-structural pharmaceutical intermediate and reference standard of critical importance in antiviral research and development. This compound is a key component in the synthesis of Ledipasvir, a direct-acting antiviral agent used in combination therapies. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and analytical laboratories engaged in the production and quality control of Hepatitis C Virus (HCV) treatments. The D-tartrate salt form offers specific physicochemical properties advantageous for formulation and process development.

Application

• Pharmaceutical Intermediate: A critical building block in the synthesis of the active pharmaceutical ingredient (API) Ledipasvir.
• Reference Standard: Used for analytical method development, validation, and quality control (HPLC, LC-MS) of Ledipasvir API and finished dosage forms.
• Research & Development: Serves as a starting material or standard in preclinical and clinical research for novel antiviral therapies targeting HCV.
• Process Chemistry: Utilized in scale-up studies and optimization of manufacturing processes for Ledipasvir-based combination drugs.
• Regulatory Submissions: Provides a characterized standard to support regulatory filings (e.g., DMF, CMC sections) with agencies like the FDA and EMA.
• Impurity Profiling: Acts as a marker or precursor in the identification and quantification of related substances and degradation products.

Basic Information

Product Name	Ledipasvir (D-Tartrate)
CAS No.	1499193-68-8
Molecular Formula	C₈₀H₁₀₀N₈O₁₈
Molecular Weight	1477.69 g/mol
Synonyms	Ledipasvir D-Tartrate; GS-5885 D-Tartrate; GS 5885 D-Tartrate; Ledipasvir tartrate salt; (2R,3R,4R,5R)-2-(2-amino-6-(cyclopropylamino)-9H-purin-9-yl)-5-(2-((S)-2-((S)-1-((2S,4S)-2-(5-(2-((2S,4S)-1-((2S)-2-((methoxycarbonyl)amino)-3-methylbutanoyl)-4-(methoxymethyl)-2-pyrrolidinyl)-1H-imidazol-2-yl)-1H-benzo[d]imidazol-2-yl)-4-(methoxymethyl)-2-pyrrolidinyl)-3-methyl-1-oxobutan-2-yl)-1H-imidazol-5-yl)-1H-benzo[d]imidazol-1-yl)tetrahydrofuran-3,4-diyl diacetate (2R,3R)-2,3-dihydroxybutanedioate; Ledipasvir (2R,3R)-2,3-dihydroxybutanedioate
EINECS	Contact for details

Quality Control

Our Ledipasvir (D-Tartrate) is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and assay, identification by spectroscopic methods (IR, NMR), and control of specific impurities and residual solvents. We provide full traceability and Certificates of Analysis (COA) are available for every shipment, ensuring compliance with cGMP guidelines and customer-specific requirements for pharmaceutical development.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept under inert conditions (e.g., nitrogen atmosphere) after opening to prevent degradation. Ensure the storage area is well-ventilated and separate from incompatible materials.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	≥98.0% (anhydrous basis)
Water Content (KF)	≤2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤20 ppm
Specific Impurities (HPLC)	Individual: ≤0.5%; Total: ≤1.5%

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