Description

Loratadine Impurity 17 is a specified impurity used in the quality control and analytical profiling of the active pharmaceutical ingredient (API) Loratadine. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of Loratadine-based drug products. It serves as a key reference standard for method development, validation, and routine batch analysis in the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Loratadine API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to confirm that Loratadine batches meet stringent pharmacopeial specifications (USP, EP, BP).
• Stability Studies: Employed to track the formation of degradation products in Loratadine under various stress conditions (thermal, photolytic, hydrolytic).
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to agencies like the FDA and EMA.
• Research & Development: Supports synthetic route optimization and process chemistry research to minimize impurity formation during Loratadine manufacturing.

Basic Information

Product Name	Loratadine Impurity 17
CAS No.	133330-72-0
Molecular Formula	C22H23ClN2O2
Molecular Weight	382.89 g/mol
Synonyms	Desloratadine Impurity; 8-Chloro-6,11-dihydro-11-(4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; Loratadine Related Compound; 8-Chloro-11-(4-piperidinylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine; Descarboethoxyloratadine; Loratadine EP Impurity C; Loratadine USP Related Compound; 133330-72-0
EINECS	Contact for details

Quality Control

Our Loratadine Impurity 17 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC purity assay, residual solvent analysis, and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) with detailed chromatographic data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent absorption of atmospheric moisture.

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 single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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