Description

4-Epitetracycline Hydrochloride CAS NO 23313-80-6 is a tetracycline derivative of significant interest in pharmaceutical research and development. This compound serves as a crucial intermediate and reference standard for the synthesis and analytical study of tetracycline-class antibiotics. It is primarily utilized by research institutions, pharmaceutical manufacturers, and quality control laboratories engaged in antibiotic development, impurity profiling, and metabolic studies. The material's defined structure makes it essential for ensuring product purity and regulatory compliance in the production of related antimicrobial agents.

Application

• Pharmaceutical Reference Standard: Used as a high-purity certified standard for the identification and quantification of 4-Epitetracycline and related tetracycline impurities in drug substances and finished products via HPLC and other analytical methods.
• Antibiotic Research Intermediate: Serves as a key synthetic building block in the research and development of novel tetracycline antibiotics and their derivatives.
• Metabolite Studies: Employed in pharmacological and toxicological research to study the metabolism, stability, and degradation pathways of tetracycline drugs.
• Quality Control & Impurity Profiling: Critical for pharmaceutical quality assurance laboratories to monitor and control the levels of epimeric impurities during the manufacturing process of tetracycline hydrochloride, ensuring compliance with pharmacopeial standards (e.g., USP, EP).
• Biochemical Research: Used in microbiological and biochemical assays to investigate the structure-activity relationships (SAR) and mechanism of action of tetracyclines.

Basic Information

Product Name	4-Epitetracycline Hydrochloride
CAS No.	23313-80-6
Molecular Formula	C₂₂H₂₅ClN₂O₈
Molecular Weight	480.90 g/mol
Synonyms	4-Epitetracycline HCl; 4-Epi-tetracycline hydrochloride; (4S,4aR,5S,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride; Tetracycline, 4-epi-, hydrochloride; 4-Epitetracycline monohydrochloride; 4-Epi-TC HCl
EINECS	Contact for details

Quality Control

Our 4-Epitetracycline Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity and assay, IR for identification, and tests for related substances and residual solvents, to ensure it meets high-purity standards suitable for research and pharmaceutical applications. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified parameters.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and light-sensitive; therefore, containers must be kept tightly sealed in a dry environment and opened under controlled conditions to minimize exposure to atmospheric moisture and light.

Specification

Item	Specification
Appearance	Yellow to yellowish-brown crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Individual unspecified impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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