Description

Doxycycline Impurity 7 (n-Desmethyl Doxycycline) is a key pharmaceutical reference standard used for the identification and quantification of process-related impurities in doxycycline drug substances and finished products. This high-purity compound is essential for ensuring the safety, efficacy, and regulatory compliance of antibiotic formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for quality control, method validation, and research and development purposes.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for analytical method development and validation (HPLC, LC-MS) in doxycycline production.
• Quality Control & Assurance: Critical for monitoring and controlling impurity profiles in active pharmaceutical ingredients (APIs) and finished drug products to meet pharmacopeial specifications (USP, EP).
• Regulatory Compliance & Documentation: Used to prepare impurity samples for regulatory filings (e.g., ANDA, NDA) and to demonstrate thorough impurity characterization to agencies like the FDA and EMA.
• Research & Development: Employed in stability studies, degradation pathway elucidation, and metabolic research related to doxycycline.
• Calibration & System Suitability: Acts as a calibrant for ensuring the accuracy and precision of chromatographic systems used in pharmaceutical analysis.

Basic Information

Product Name	Doxycycline Impurity 7 (n-Desmethyl Doxycycline)
CAS No.	86271-83-2
Molecular Formula	C21H23N2O8
Molecular Weight	431.42 g/mol
Synonyms	n-Desmethyl Doxycycline; 6-Desmethyl Doxycycline; Doxycycline Impurity D; Doxycycline Related Compound D; 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide; Doxycycline EP Impurity D; Doxycycline USP Related Compound D
EINECS	Contact for details

Quality Control

Every batch of Doxycycline Impurity 7 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) detailing batch-specific results is provided with each shipment to support your quality and regulatory requirements.

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 must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Single Unknown Impurity (HPLC)	≤ 1.0%
Total Impurities (HPLC)	≤ 5.0%

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