Description

Loratadine Impurity 9 is a specified impurity and reference standard used in the analytical profiling of the antihistamine drug, Loratadine. This compound is critical for pharmaceutical quality control, enabling manufacturers to monitor, identify, and quantify related substances to ensure drug safety and efficacy. It is an essential material for analytical laboratories, R&D departments, and quality assurance teams in the pharmaceutical industry involved in method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Loratadine Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Critical component in developing and validating High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Loratadine products meet stringent pharmacopeial specifications (e.g., USP, EP, ICH guidelines) for impurity limits.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing applications.
• Stability Studies: Employed to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as per ICH Q1A(R2) guidelines.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes for the Loratadaine API.

Basic Information

Product Name	Loratadine Impurity 9
CAS No.	125743-81-9
Molecular Formula	C22H23ClN2O2
Molecular Weight	382.89 g/mol
Synonyms	Desloratadine Related Compound A; 8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; Loratadine EP Impurity A; Loratadine USP Related Compound A; 11-(Piperidin-4-ylidene)-8-chloro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; Descarboethoxyloratadine; Loratadine Impurity A
EINECS	Contact for details

Quality Control

Every batch of Loratadine Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, GC, NMR, and MS to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and confirming compliance with relevant pharmacopeial guidelines (USP, EP) and ICH Q3A/B specifications.

Storage

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

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)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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