Description

Conivaptan Impurity CAS NO 1129433-63-1 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 the active pharmaceutical ingredient (API) Conivaptan. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Conivaptan Hydrochloride API during quality control (QC) and quality assurance (QA) processes.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, to ensure accurate impurity detection in pharmaceutical formulations.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing a characterized impurity standard for stability studies and specification setting.
• Research & Development (R&D): Employed in pharmaceutical R&D to study the degradation pathways, stability, and metabolism of Conivaptan.
• Contract Research Organization (CRO) Services: Supplied to CROs and testing laboratories that provide outsourced analytical services to the pharmaceutical industry.
• Pharmacopoeial Standards: Serves as a potential impurity standard in alignment with pharmacopoeial monographs (e.g., USP, EP) for Conivaptan.

Basic Information

Product Name	Conivaptan Impurity
CAS No.	1129433-63-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Conivaptan Related Compound; Conivaptan Impurity Standard; Conivaptan Specified Impurity; YM-087 Impurity; (R)-N-[4-(5-Chloro-1,2,3,4-tetrahydro-2-benzazepin-3-yl)benzoyl]-2-methyl-β-alanine Impurity; Vaprisol Impurity; Benzazepine Derivative Impurity; Conivaptan Hydrochloride Impurity
EINECS	Contact for details

Quality Control

Every batch of Conivaptan Impurity (CAS 1129433-63-1) is manufactured and handled under strict quality management systems. Our products undergo rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

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 reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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