Description

Doxycycline Hyclate Impurity F is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the antibiotic doxycycline hyclate during its development and manufacturing. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory bodies involved in analytical method development and validation.

Application

This impurity standard is primarily utilized in the following scenarios:

• Pharmaceutical Quality Control (QC): Serves as a reference standard for the identification and quantification of Impurity F in doxycycline hyclate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical component in developing, optimizing, and validating HPLC, UPLC, or other chromatographic methods for impurity profiling.
• Regulatory Compliance and Documentation: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization and control strategies.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions to establish product shelf-life.
• Research and Development: Used in studies to understand the degradation pathways and chemical behavior of doxycycline hyclate.

Basic Information

Product Name	Doxycycline Hyclate Impurity F
CAS No.	122861-53-4
Molecular Formula	C22H24N2O8 • HCl • 0.5 H2O • 0.5 C2H6O
Molecular Weight	512.94 g/mol (for the hyclate salt form)
Synonyms	4-Epidoxycycline Hydrochloride Hemihydrate Ethanolate; 4-Epidoxycycline Hyclate; Doxycycline EP Impurity F; Doxycycline Related Compound F; (4S,4aR,5S,5aR,6R,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide Hydrochloride Hemihydrate Ethanolate
EINECS	Contact for details

Quality Control

Every batch of Doxycycline Hyclate Impurity F is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, NMR, and MS to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each 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 material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider conditions of 2-8°C.

Specification

Item	Specification
Appearance	Yellow to light yellow powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	2.0% - 6.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual unknown impurity ≤ 0.5% Total impurities ≤ 5.0%

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