Description

Acrivastine Impurity 1 (Acrivastine 2,3-Dihydro Impurity) is a specified impurity of the antihistamine drug Acrivastine, identified by CAS number 87849-01-2. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Acrivastine active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Acrivastine API and formulations.
• Analytical Method Development: Crucial for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to ensure Acrivastine products meet stringent pharmacopeial specifications (e.g., ICH Q3A/B).
• Stability Studies: Employed to track the formation of this specific degradant under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the preparation of regulatory dossiers (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Process Chemistry Research: Aids in optimizing synthesis and purification processes to minimize the formation of this impurity.

Basic Information

Product Name	Acrivastine Impurity 1 (Acrivastine 2,3-Dihydro Impurity)
CAS No.	87849-01-2
Molecular Formula	C22H24N2O2
Molecular Weight	348.44 g/mol
Synonyms	Acrivastine Dihydro Impurity; Acrivastine Related Compound A; (E)-3-[6-[(E)-1-(4-Methylphenyl)-3-pyrrolidin-1-ylprop-1-enyl]pyridin-2-yl]acrylic Acid; 2,3-Dihydroacrivastine; Acrivastine Impurity B; Acrivastine EP Impurity B; Acrivastine USP Impurity
EINECS	Contact for details

Quality Control

Our Acrivastine Impurity 1 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic (HPLC, LC-MS) and spectroscopic (NMR, IR) techniques. We support compliance with ICH guidelines and relevant pharmacopeial standards for impurity characterization.

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 desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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