Description

Cyproheptadine Impurity 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 purity, identify potential contaminants, and meet stringent regulatory requirements. It is primarily utilized in the development, validation, and routine testing of Cyproheptadine active pharmaceutical ingredients (APIs) and finished dosage forms.

Application

• Primary use as a pharmaceutical reference standard for analytical method development and validation.
• Critical component in impurity identification and quantification during Cyproheptadine API manufacturing.
• Essential for stability studies and forced degradation studies to monitor impurity profiles.
• Used in quality control (QC) laboratories for routine batch release testing.
• Supports regulatory filings (e.g., ANDA, NDA) by providing impurity characterization data.
• Valuable for academic and clinical research investigating Cyproheptadine metabolism and related compounds.

Basic Information

Product Name	Cyproheptadine Impurity
CAS No.	54381-58-7
Molecular Formula	C21H21N
Molecular Weight	287.40 g/mol
Synonyms	1-Methyl-4-(5H-dibenzo[a,d]cyclohepten-5-ylidene)piperidine; Desmethylcyproheptadine; Cyproheptadine Desmethyl Impurity; Cyproheptadine Related Compound A; Norcyproheptadine; NSC 169865; 5-(1-Methyl-4-piperidinylidene)-5H-dibenzo[a,d]cycloheptene
EINECS	Contact for details

Quality Control

Our Cyproheptadine Impurity is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation by spectroscopic methods (IR, NMR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) with batch-specific data is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 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 degradation.

Specification

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

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