Description

Loratadine Impurity 12 CAS NO 31251-40-8 is a specified impurity and reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Loratadine. This compound is critical for ensuring the quality, safety, and efficacy of antihistamine drug products by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions engaged in method development, stability studies, and regulatory compliance for generic and innovator drug formulations.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of impurities in Loratadine API and finished dosage forms.
• Analytical Method Development & Validation: Used as a critical component in developing and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine QC testing to ensure Loratadine batches meet pharmacopeial (USP, EP, BP, JP) or internal specification limits for related substances.
• Stability Studies: Employed to monitor the formation of degradation products in Loratadine under various stress conditions (e.g., heat, light, humidity) over time.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTD), and other regulatory filings to demonstrate comprehensive impurity control.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Loratadine.

Basic Information

Product Name	Loratadine Impurity 12
CAS No.	31251-40-8
Molecular Formula	C22H23ClN2O2
Molecular Weight	382.89 g/mol
Synonyms	Loratadine Related Compound A; 8-Chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-5-one; Desloratadine Impurity; Claritin Impurity; SCH 29851 Impurity; 4-(8-Chloro-5,6-dihydro-11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-ylidene)-1-methylpiperidine; 11-(1-Methyl-4-piperidinylidene)-8-chloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine-5-one
EINECS	Contact for details

Quality Control

Every batch of Loratadine Impurity 12 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated analytical methods (e.g., HPLC, NMR, MS) to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm

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