Description

n-Nitroso-7-Monomethylamino-6-Deoxytetracycline Impurity is a structurally defined impurity and reference standard critical for the analytical profiling of tetracycline-class antibiotics. This compound matters significantly for pharmaceutical manufacturers and research laboratories focused on ensuring drug safety, purity, and regulatory compliance. It is primarily needed by professionals in pharmaceutical development, quality control (QC), and analytical chemistry for use in method validation, stability studies, and impurity identification.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in tetracycline antibiotic active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating sensitive HPLC, UPLC, or LC-MS methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability and Forced Degradation Studies: Employed to understand the degradation pathways of 7-monomethylamino-6-deoxytetracycline and related compounds under various stress conditions (light, heat, pH).
• Quality Control & Batch Release Testing: Serves as a system suitability and identification marker in the routine QC testing of antibiotic batches to ensure they meet stringent purity specifications.
• Regulatory Submissions: Provides critical data for regulatory filings (e.g., with the FDA, EMA) to establish impurity limits and justify the control strategy for drug substances.
• Research on Nitrosamine Impurities: Acts as a model compound in studies investigating the formation, analysis, and control of potentially genotoxic nitrosamine impurities in pharmaceuticals.

Basic Information

Product Name	n-Nitroso-7-Monomethylamino-6-Deoxytetracycline Impurity
CAS No.	28698-93-3
Molecular Formula	C₂₃H₂₅N₃O₈
Molecular Weight	471.46 g/mol
Synonyms	7-(Methyl(nitroso)amino)-6-deoxy-5-oxytetracycline; N-Nitroso-7-monomethylamino-6-deoxytetracycline; 7-(N-Methyl-N-nitroso)amino-6-deoxytetracycline; Nitroso Sancycline Impurity; 6-Deoxy-5-hydroxy-7-(methyl(nitroso)amino)tetracycline; Tetracycline Nitrosamine Impurity; 28698-93-3
EINECS	Contact for details

Quality Control

Every batch of this high-purity impurity standard is manufactured and analyzed under strict quality management systems. Certificates of Analysis (COA) are provided, detailing comprehensive characterization data including purity by HPLC, identity confirmation by spectroscopic methods (IR, MS, NMR), and impurity profile. Our quality protocols are designed to support GMP/GLP-compliant applications and meet the rigorous standards required for pharmaceutical reference materials.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. Keep the container tightly sealed in a cool, dry, and well-ventilated place.

Specification

Item	Specification
Appearance	Yellow to orange-yellow powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report individual and total impurities
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.