Description

Doxycycline Monohydrate is a semi-synthetic, broad-spectrum tetracycline antibiotic derivative. It is valued for its high potency, excellent bioavailability, and effectiveness against a wide range of gram-positive and gram-negative bacteria, as well as atypical pathogens. This active pharmaceutical ingredient (API) is essential for manufacturers in the pharmaceutical industry producing oral dosage forms for human and veterinary medicine.

Application

• Human Pharmaceutical Formulations: Primary API in capsules, tablets, and oral suspensions for treating respiratory infections, Lyme disease, acne, and various other bacterial infections.
• Veterinary Medicinal Products: Key ingredient in medicated feeds, powders, and injectables for treating bacterial diseases in livestock, poultry, and companion animals.
• Research & Development: Used as a critical biochemical tool in microbiological and pharmacological research studies.
• Reference Standard: Serves as a high-purity analytical standard for quality control laboratories in pharmaceutical manufacturing.

Basic Information

Product Name	Doxycycline Monohydrate
CAS No.	17086-28-1
Molecular Formula	C22H24N2O8 • H2O
Molecular Weight	462.46 g/mol
Synonyms	Doxycycline Hydate; Doxycycline Monohydrate USP; (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 monohydrate; GS 3065; Vibramycin Monohydrate; Doxylin; Monodox; α-6-Deoxy-5-oxytetracycline Monohydrate
EINECS	241-154-5

Quality Control

Our Doxycycline Monohydrate is manufactured under strict quality management systems. It is tested to meet or exceed relevant pharmacopeial standards such as USP, EP, and BP. Every batch is accompanied by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles to ensure reliable consistency and regulatory compliance for pharmaceutical applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a low-humidity environment to maintain stability and potency.

Specification

Item	Specification
Appearance	Yellow crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	96.0% - 102.0% (on anhydrous basis)
Water Content (KF)	3.0% - 6.0%
pH (1% Suspension)	2.0 - 3.5
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Meets pharmacopeial requirements
Residual Solvents (GC)	Meets ICH guidelines
Microbial Enumeration	Meets EP/USP criteria

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