Description

Minocycline n-Hydroxymethyl Impurity (CAS 1075240-33-3) is a high-purity chemical reference standard critical for the analytical profiling and quality control of the antibiotic Minocycline. This impurity is essential for pharmaceutical manufacturers and research laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily used by professionals in pharmaceutical development, quality assurance (QA), and regulatory affairs who require reliable reference materials for method validation and stability studies.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference standard for the identification and quantification of the n-Hydroxymethyl derivative in Minocycline Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used as a critical component in developing and validating High-Performance Liquid Chromatography (HPLC) and Ultra-High-Performance Liquid Chromatography (UHPLC) methods for purity analysis.
• Stability Studies & Forced Degradation: Employed to monitor the formation of this specific degradant under various stress conditions (e.g., heat, humidity, light) as part of ICH guideline compliance.
• Quality Control (QC) & Batch Release Testing: Essential for in-house QC laboratories to establish specification limits and ensure every batch of Minocycline API meets stringent purity criteria.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry and pharmacology research to study the degradation pathways and metabolic profiles of tetracycline antibiotics.

Basic Information

Item	Detail
Product Name	Minocycline n-Hydroxymethyl Impurity
CAS No.	1075240-33-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Minocycline Impurity F (n-Hydroxymethyl Minocycline); 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide, 9-(Hydroxymethyl)-; 9-(Hydroxymethyl)minocycline; Minocycline Related Compound F; Minocycline n-Hydroxymethyl Degradant
EINECS	Contact for details

Quality Control

Every batch of our Minocycline n-Hydroxymethyl Impurity is manufactured and handled under strict quality management systems. The material undergoes rigorous analytical testing, including advanced chromatographic techniques, to ensure identity, purity, and stability. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the standards expected for pharmaceutical reference materials, supporting compliance with ICH Q3A, Q3B, and cGMP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. Due to its hygroscopic (moisture-sensitive) nature, the container must be kept in a dry environment. For long-term storage, consider desiccants or inert atmosphere to maintain stability.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content	≤ 5.0%
Residual Solvents (GC)	Complies with ICH limits

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