Description

Aripiprazole Usp Rc H CAS NO 1796928-63-6 is a high-purity reference standard material, specifically the USP Reference Standard (RS) grade for the impurity known as Aripiprazole Related Compound H. This certified standard is critical for analytical method development, validation, and quality control testing in pharmaceutical manufacturing. It is an essential tool for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Aripiprazole. Pharmaceutical companies, contract research organizations (CROs), and regulatory testing laboratories rely on this standard for precise identification and quantification of this specific impurity.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material to identify and quantify Aripiprazole Related Compound H in drug substance and drug product batches.
• Analytical Method Development and Validation: Serves as a critical component in developing and validating HPLC, UPLC, or other chromatographic methods for impurity analysis.
• Quality Control and Release Testing: Employed in routine QC laboratories to ensure Aripiprazole API and finished dosage forms meet stringent pharmacopeial (USP, EP) impurity limits.
• Stability Studies: Used to monitor the formation of Related Compound H as a potential degradation product during drug stability testing under various conditions.
• Regulatory Compliance and Submissions: Provides essential data for regulatory filings (e.g., ANDA, NDA) to demonstrate control over known and specified impurities.
• Calibration of Analytical Instruments: Acts as a primary standard for calibrating equipment used in pharmaceutical analysis to ensure accurate and reproducible results.

Basic Information

Product Name	Aripiprazole Usp Rc H
CAS No.	1796928-63-6
Molecular Formula	C23H27Cl2N3O2
Molecular Weight	464.39 g/mol
Synonyms	7-{4-[4-(2,3-Dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1H)-one; Aripiprazole Related Compound H; Aripiprazole Impurity H; USP Aripiprazole Related Compound H RS; Aripiprazole RS H; Aripiprazole USP Reference Standard H
EINECS	Contact for details

Quality Control

This USP Reference Standard material is manufactured and certified under strict quality systems to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) that includes data from orthogonal analytical techniques such as NMR, Mass Spectrometry, and HPLC. The COA provides detailed information on assay value, related substances, and confirmation against the official USP monograph specifications. Our quality commitment ensures full compliance with the rigorous standards required for pharmaceutical reference materials.

Storage

Preserve in the original sealed container as supplied. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and light-sensitive; therefore, the container must be kept tightly closed and protected from light and moisture. Desiccate if necessary. For long-term storage, consider storing under inert atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Complies with USP limits
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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