Description

Omadacycline is a novel, semi-synthetic aminomethylcycline antibiotic belonging to the tetracycline class. It is valued for its broad-spectrum activity against Gram-positive, Gram-negative, and atypical pathogens, including those resistant to other tetracyclines. This makes it a critical active pharmaceutical ingredient (API) for pharmaceutical manufacturers developing next-generation antibacterial therapies to address serious community-acquired infections.

Application

• Primary use as an Active Pharmaceutical Ingredient (API) in the formulation of antibacterial drugs.
• Development of oral and intravenous dosage forms for the treatment of community-acquired bacterial pneumonia (CABP).
• Development of oral and intravenous dosage forms for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
• Research and development of novel antibiotic combinations to combat multi-drug resistant organisms.
• Use in pharmaceutical reference standards for quality control and analytical testing.
• Pre-clinical and clinical trial material for new antibacterial drug candidates.

Basic Information

Product Name	Omadacycline
CAS No.	389139-89-3
Molecular Formula	C29H40N4O7
Molecular Weight	556.66 g/mol
Synonyms	PTK 0796; Amadacycline; (4S,4aS,5aR,12aS)-4,7-Bis(dimethylamino)-9-[[(2,2-dimethylpropyl)amino]methyl]-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide; Amadacycline methanesulfonate; NUZYRA (Brand Name)
EINECS	Contact for details

Quality Control

Our Omadacycline is manufactured under strict quality systems to ensure it meets the stringent requirements for pharmaceutical active ingredients. Quality is assured through comprehensive analytical testing, including HPLC for purity and related substances, residual solvent analysis, and microbiological testing. A Certificate of Analysis (COA) is provided with each batch, detailing compliance with in-house specifications aligned with ICH guidelines. We support our partners with full regulatory documentation for drug master files (DMF).

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its light-sensitive nature, the container should be kept in the original outer packaging until use. For long-term storage, consider conditions under an inert atmosphere to minimize potential oxidation.

Specification

Item	Specification
Appearance	Yellow to orange-yellow powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Microbiological Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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