Description

4-Epianhydrochlortetracycline Hydrochloride is a high-purity chemical reference standard derived from the tetracycline class of antibiotics. This compound is critically important for analytical and quality control laboratories, serving as a secondary standard for the precise calibration of instruments and validation of analytical methods. It is primarily used by pharmaceutical manufacturers, contract research organizations (CROs), and regulatory testing facilities to ensure the accuracy, consistency, and compliance of their assays for tetracycline-related substances.

Application

• Pharmaceutical Quality Control (QC): Used as a secondary reference standard for the identification and quantification of related substances in bulk active pharmaceutical ingredients (APIs) and finished drug products containing tetracycline derivatives.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating high-performance liquid chromatography (HPLC), UPLC, or LC-MS/MS methods in compliance with ICH Q2(R1) guidelines.
• Regulatory Compliance & Documentation: Supports regulatory submissions (e.g., to FDA, EMA) by providing traceable and reliable data for stability studies, impurity profiling, and batch release testing.
• Research & Development: Serves as a key impurity standard in metabolic and degradation studies to understand the stability profile of chlortetracycline and related compounds.
• Calibration of Laboratory Equipment: Used to calibrate spectrophotometers and chromatographic systems to ensure measurement accuracy and reproducibility across different laboratories and time points.

Basic Information

Product Name	4-Epianhydrochlortetracycline Hydrochloride
CAS No.	158018-53-2
Molecular Formula	C22H21ClN2O7 • HCl
Molecular Weight	497.32 g/mol (for free base C22H21ClN2O7)
Synonyms	4-Epianhydrochlortetracycline HCl; 4-EATC Hydrochloride; 4-Epi-anhydro-chlortetracycline Hydrochloride; Anhydro-4-epi-chlortetracycline Hydrochloride; 4-Epianhydrochlorotetracycline Hydrochloride; Chlortetracycline Impurity Standard; Tetracycline Related Compound A (Hydrochloride form); Antibiotic Degradation Reference Standard
EINECS	Contact for details

Quality Control

Every batch of our 4-Epianhydrochlortetracycline Hydrochloride is manufactured and tested under a strict quality management system. The product is characterized and qualified using advanced analytical techniques including HPLC, NMR, and mass spectrometry to ensure identity, purity, and suitability for use as a secondary standard. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality assurance requirements.

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 desiccated environment and opened under controlled conditions to minimize exposure to atmospheric moisture and light.

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference
Assay (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 2.0%; Total impurities ≤ 5.0%

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