Description

Ledipasvir Impurity 1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of Ledipasvir, a key active pharmaceutical ingredient in antiviral medications. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing. The precise characterization of this impurity is essential for maintaining compliance with stringent pharmacopeial standards.

Application

• Primary use as a certified reference standard for the quantitative and qualitative analysis of Ledipasvir.
• Critical component in pharmaceutical research and development for impurity profiling and identification.
• Essential for quality control (QC) and quality assurance (QA) laboratories in API manufacturing.
• Used in method validation and stability studies to meet ICH and regulatory guidelines.
• Serves as a key impurity marker in HPLC, LC-MS, and GC-MS analytical methodologies.
• Supports regulatory submissions (e.g., for FDA, EMA) requiring detailed impurity characterization.

Basic Information

Product Name	Ledipasvir Impurity 1
CAS No.	2040487-43-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Ledipasvir Related Compound 1; Ledipasvir Impurity A; GS-5885 Impurity 1; (M)-Isomer of Ledipasvir; Ledipasvir EP Impurity A; Ledipasvir USP Impurity; HCV NS5A Inhibitor Impurity
EINECS	Contact for details

Quality Control

Every batch of Ledipasvir Impurity 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including potential alignment with USP, EP, and ICH guidelines for impurities. Comprehensive characterization is performed using advanced spectroscopic and chromatographic techniques. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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