Description

Loratadine Impurity I CAS NO 133330-56-0 is a specified impurity and a key reference standard used in the quality control of the active pharmaceutical ingredient (API) Loratadine. This compound is critical for ensuring the purity, safety, and efficacy of antihistamine drug products by enabling accurate identification and quantification of related substances. It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and quality assurance processes.

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: Used to develop, optimize, and validate HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Batch Release Testing: A critical component in routine QC testing to ensure API batches comply with pharmacopoeial limits (e.g., USP, EP, ICH Q3A/B) for related substances.
• Stability Studies: Employed to monitor the formation of degradation products in Loratadine formulations under various stress conditions.
• Regulatory Submissions: Required for preparing regulatory documentation (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity control strategies.
• Research & Development: Used in synthetic route development, process optimization, and impurity fate and tolerance studies during API manufacturing.

Basic Information

Product Name	Loratadine Impurity I
CAS No.	133330-56-0
Molecular Formula	C22H23ClN2O2
Molecular Weight	382.89 g/mol
Synonyms	8-Chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-5-one; Loratadine Related Compound A; Desloratadine Impurity; Loratadine EP Impurity A; Loratadine USP Related Compound A; 5H-Benzo[5,6]cyclohepta[1,2-b]pyridin-5-one, 8-chloro-6,11-dihydro-11-(1-methyl-4-piperidinylidene)-; Descarboethoxyloratadine
EINECS	Contact for details

Quality Control

Our Loratadine Impurity I is manufactured and handled under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, related substance analysis, and structural confirmation (IR, MS, NMR) to ensure identity, purity, and traceability. Certificates of Analysis (COA) with detailed chromatographic data are provided and are compliant with current standards for pharmaceutical reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The container should be kept in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

Specification

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

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