Description

Acrivastine Impurity 5 is a designated impurity standard of the antihistamine drug Acrivastine. This high-purity reference material is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical and fine chemical industries who require reliable standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Acrivastine Impurity 5 in active pharmaceutical ingredient (API) and finished drug product analysis.
• Analytical Method Development & Validation: Serves as a critical component in developing and validating HPLC, UPLC, or LC-MS methods for impurity profiling of Acrivastine.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor and control impurity levels, ensuring compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of drug stability testing programs.
• Regulatory Submissions: Provides essential data for impurity identification and qualification in regulatory filings (e.g., for FDA, EMA) for Acrivastine-based drug products.
• Research & Development: Utilized in synthetic chemistry R&D to understand impurity formation pathways and to optimize purification processes for Acrivastine API.

Basic Information

Product Name	Acrivastine Impurity 5
CAS No.	1057138-89-2
Molecular Formula	C22H24N2O2
Molecular Weight	348.44 g/mol
Synonyms	(E)-3-[6-[(E)-1-(4-Methylphenyl)-3-pyrrolidin-1-ylprop-1-enyl]pyridin-2-yl]acrylic acid; Acrivastine Related Compound; Acrivastine EP Impurity; Acrivastine USP Impurity; Acrivastine Process Impurity; Acrivastine Degradant
EINECS	Contact for details

Quality Control

Every batch of Acrivastine Impurity 5 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical characterization using techniques such as HPLC, GC, NMR, and MS to confirm identity and ensure high purity, typically ≥95% (HPLC). A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.