Description

Lcz Impurity CAS NO 753421-85-1 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products by serving as a benchmark in impurity profiling and method validation. It is primarily utilized by research scientists and quality control professionals in the pharmaceutical and biotechnology industries for drug development and manufacturing.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific impurities in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Serves as a critical standard for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to ensure accuracy and reproducibility.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor batch-to-batch consistency and to confirm that impurity levels are within specified regulatory limits.
• Stability Studies: Used to track the formation and growth of degradation products in drug substances and products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Supports synthetic chemistry research by helping to understand degradation pathways and to synthesize purer target molecules.

Basic Information

Product Name	Lcz Impurity CAS NO 753421-85-1
CAS No.	753421-85-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Lcz Impurity; Lcz Related Compound; 753421-85-1; Lcz Process Impurity; Lcz Degradant; Lcz Analytical Standard; Lcz Reference Standard; Lcz Specified Impurity
EINECS	Contact for details

Quality Control

Every batch of Lcz Impurity CAS NO 753421-85-1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA), detailing batch-specific results, is provided with each shipment to guarantee traceability and reliability for your critical applications.

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 (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines

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