Description

Demeclocycline Impurity E(Ep) is a specified impurity of the antibiotic Demeclocycline, a tetracycline-class drug. This compound is critical for pharmaceutical research and development, serving as a reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Demeclocycline API and its formulations.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Demeclocycline active pharmaceutical ingredient (API).
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and other chromatographic methods for purity analysis.
• Quality Control & Assurance (QC/QA): Used in routine batch testing to monitor impurity profiles and ensure compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing impurity characterization data.
• Research & Development: Used in studies investigating the degradation pathways, metabolism, and synthesis of tetracycline antibiotics.

Basic Information

Item	Detail
Product Name	Demeclocycline Impurity E(Ep)
CAS No.	22756-01-0
Molecular Formula	C₂₁H₂₁ClN₂O₈
Molecular Weight	464.86 g/mol
Synonyms	4-Epidemeclocycline; Demeclocycline EP Impurity E; 4-Epi-Demeclocycline; Demeclocycline Impurity E (4-epi); (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; 4-Epimer of Demeclocycline; Demeclocycline Related Compound E
EINECS	Contact for details

Quality Control

Every batch of Demeclocycline Impurity E(Ep) is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, NMR, and MS to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, chromatographic data, and spectroscopic confirmation is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at 2-8°C. This product is hygroscopic (moisture-sensitive) and light-sensitive. For long-term storage, consider storage under an inert atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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