Description

Minocycline 5,6A-Dehydro Impurity is a key process-related impurity and degradation product of the broad-spectrum tetracycline antibiotic, Minocycline. This compound is of critical importance in pharmaceutical development and manufacturing for ensuring drug safety, efficacy, and regulatory compliance. It is primarily required by analytical laboratories and pharmaceutical companies for use as a certified reference standard in quality control testing, method validation, and stability studies.

Application

• Pharmaceutical Reference Standard: Serves as a high-purity certified reference material (CRM) for the identification and quantification of impurities in Minocycline Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurity profiles.
• Stability Indicating Studies: Used to assess the degradation pathways and shelf-life of Minocycline formulations under various stress conditions (e.g., heat, light, humidity).
• Quality Control & Batch Release: Critical for in-house QC laboratories to ensure batches of Minocycline API meet stringent pharmacopeial (USP, EP) specifications for impurity limits.
• Regulatory Submissions: Provides necessary data on impurity characterization and control strategies for regulatory filings (e.g., with FDA, EMA).
• Research & Development: Used in R&D to study the synthesis, degradation kinetics, and toxicological profile of Minocycline-related substances.

Basic Information

Product Name	Minocycline 5,6A-Dehydro Impurity
CAS No.	1346598-44-4
Molecular Formula	C₂₃H₂₇N₃O₇
Molecular Weight	457.48 g/mol
Synonyms	5,6A-Dehydro Minocycline; 5,6A-Didehydro Minocycline; Minocycline 5,6A-Dehydro Derivative; Minocycline Impurity; Minocycline Related Compound; (4S,4aS,5aR,12aS)-4,7-Bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide; 2-Naphthacenecarboxamide, 4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-, (4S,4aS,5aR,12aS)-
EINECS	Contact for details

Quality Control

Our Minocycline 5,6A-Dehydro Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for use as a reference material. Each batch is characterized and tested for identity, purity, and impurities using advanced techniques including HPLC, MS, and NMR. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results and confirming compliance with in-house specifications tailored for pharmaceutical impurity analysis.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown 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.