Description

Minocycline 9-Methylamino Impurity is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound is essential for the analytical characterization and quality control of the antibiotic Minocycline, ensuring the safety and efficacy of the final drug product. It is primarily used by researchers and quality assurance professionals in the pharmaceutical industry for method development, validation, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Minocycline Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development: Critical for developing and validating HPLC, UPLC, and other chromatographic methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., USP, EP, ICH Q3A/B).
• Stability Studies: Employed to track the formation and levels of this specific degradation product during forced degradation and long-term stability testing of Minocycline formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Minocycline.

Basic Information

Product Name	Minocycline 9-Methylamino Impurity
CAS No.	607402-73-3
Molecular Formula	C₂₃H₂₇N₅O₇
Molecular Weight	485.49 g/mol
Synonyms	9-(Methylamino)minocycline; Minocycline Impurity F (EP); Minocycline Related Compound F; 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-9-(methylamino)-1,11-dioxo-2-naphthacenecarboxamide; Minocycline EP Impurity F; Minocycline USP Related Compound F; Minocycline 9-Methylamino Degradant
EINECS	Contact for details

Quality Control

Our Minocycline 9-Methylamino Impurity is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the highest standards for pharmaceutical reference materials. Each batch is characterized and controlled against comprehensive specifications, including identity, purity, and impurity profile, in compliance with ICH guidelines. A detailed Certificate of Analysis (COA) providing full analytical results is supplied with every shipment.

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 should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	Yellow to orange powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% 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.