Description

Aureomycin Impurity K(Ep) is a specified impurity of the antibiotic Chlortetracycline (Aureomycin). This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development and validation. It is essential for quality control laboratories in the pharmaceutical industry to ensure the purity, safety, and efficacy of Chlortetracycline-based drug substances and products. Researchers and manufacturers rely on this high-purity impurity standard to meet stringent regulatory requirements for impurity profiling.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of Aureomycin Impurity K(Ep) in Chlortetracycline API.
• Critical component in analytical method development and validation for HPLC, UPLC, and LC-MS systems.
• Essential for pharmaceutical quality control (QC) and stability studies to monitor impurity levels.
• Used in regulatory compliance and submission packages to demonstrate thorough impurity characterization.
• Valuable material for research and development of Chlortetracycline synthesis and purification processes.
• Supports pharmacopoeial testing to meet standards set by USP, EP, and other international bodies.

Basic Information

Product Name	Aureomycin Impurity K(Ep)
CAS No.	81163-11-3
Molecular Formula	C₂₂H₂₂ClN₂O₈
Molecular Weight	477.87 g/mol
Synonyms	Chlortetracycline Impurity K(Ep); 4-Epichlortetracycline; (4S,4aS,5aS,6S,12aS)-7-Chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide; Aureomycin EP Impurity K; CTC Impurity K(Ep)
EINECS	Contact for details

Quality Control

Every batch of Aureomycin Impurity K(Ep) is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopoeial and industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with GMP, ICH Q3A/B, and FDA guidelines for pharmaceutical impurities.

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 must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity ≤ 2.0%
Total Impurities	≤ 5.0%
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.