Description

Minocycline Impurity 9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic minocycline during its development and manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality control (QC) departments, and regulatory affairs teams for method validation, impurity profiling, and stability studies.

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 & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity levels in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Batch Release: Serves as a system suitability and calibration standard in routine QC testing to ensure minocycline batches meet stringent purity specifications.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability testing of minocycline formulations.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research & Development: Used in academic and industrial research to study the degradation pathways, metabolism, and chemical behavior of minocycline.

Basic Information

Product Name	Minocycline Impurity 9
CAS No.	601455-95-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Minocycline Related Compound 9; Minocycline EP Impurity I; Minocycline USP Impurity; Minocycline Degradant; Minocycline Process Impurity; 4-Epiminocycline; (4S,4aS,5aR,12aS)-4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide
EINECS	Contact for details

Quality Control

Every batch of Minocycline Impurity 9 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with ICH, USP, and EP guidelines for impurity standards.

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. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	Off-white to light yellow solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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