Description

Loratadine Impurity 19 is a designated chemical reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Loratadine. This impurity is critical for pharmaceutical manufacturers and analytical laboratories to ensure the purity, safety, and efficacy of the final drug product. It is primarily utilized by professionals in pharmaceutical R&D, quality assurance, and regulatory affairs for method development, validation, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Loratadine API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC/UPLC methods as per ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (USP, EP).
• Stability Studies: Employed to track the formation of degradation products in Loratadine under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Aids in understanding the degradation pathways and impurity profile of Loratadine during synthesis and formulation processes.

Basic Information

Product Name	Loratadine Impurity 19
CAS No.	79779-58-1
Molecular Formula	C22H23ClN2O2
Molecular Weight	382.89 g/mol
Synonyms	Loratadine Related Compound 19; Loratadine EP Impurity 19; Loratadine USP Impurity 19; 8-Chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-5-one; Desloratadine Impurity; 5H-Benzo[5,6]cyclohepta[1,2-b]pyridin-5-one, 8-chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-
EINECS	Contact for details

Quality Control

Our Loratadine Impurity 19 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical impurity analysis. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A, Q3B, USP, and EP guidelines. We ensure traceability and consistency for reliable results in your critical applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F), in a dry environment. For long-term stability, storage at 2-8°C is recommended.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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