Description

Cyproheptadine Impurity CAS NO 54381-57-6 is a high-purity reference standard used in the analytical profiling and quality control of the antihistamine drug, Cyproheptadine. This compound is critical for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is an essential material for professionals engaged in method development, stability studies, and impurity characterization within the pharmaceutical and analytical chemistry sectors.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of specific impurities in Cyproheptadine Hydrochloride active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical component in developing and validating HPLC, UPLC, or GC methods to ensure specificity, accuracy, and precision for impurity detection.
• Stability Indicating Studies: Employed in forced degradation and long-term stability studies to monitor the formation of degradation products and establish shelf-life for Cyproheptadine-based medications.
• Quality Control & Assurance (QC/QA): Integral for routine batch release testing in GMP environments to confirm that impurity levels are within ICH Q3A/B guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to meet FDA, EMA, and other global health authority requirements.
• Research and Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Cyproheptadine.

Basic Information

Item	Details
Product Name	Cyproheptadine Impurity
CAS No.	54381-57-6
Molecular Formula	C21H21N
Molecular Weight	287.40 g/mol
Synonyms	1-Methyl-4-(5H-dibenzo[a,d]cyclohepten-5-ylidene)piperidine; Desmethylcyproheptadine; Norcyproheptadine; Cyproheptadine Desmethyl Impurity; Cyproheptadine Related Compound A; 5-(1-Methyl-4-piperidinylidene)-5H-dibenzo[a,d]cycloheptene
EINECS	Contact for details

Quality Control

Every batch of Cyproheptadine Impurity (CAS 54381-57-6) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing, including advanced chromatographic techniques, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and other critical parameters. We support compliance with ICH guidelines and relevant pharmacopeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider using desiccants.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5%

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