Description

Ceftaroline Fosamil Acetate Monohydrate is a fifth-generation cephalosporin antibiotic prodrug, specifically designed to combat serious and resistant bacterial infections. Its primary value lies in its potent activity against Gram-positive pathogens, including methicillin-resistant *Staphylococcus aureus* (MRSA) and multidrug-resistant *Streptococcus pneumoniae*. This advanced active pharmaceutical ingredient (API) is essential for pharmaceutical manufacturers developing next-generation injectable antibiotic formulations to address critical healthcare needs.

Application

• Pharmaceutical API: Primary use as the active ingredient in the synthesis of finished injectable antibiotic drugs.
• Anti-MRSA Therapeutics: Critical component in formulations targeting life-threatening infections caused by methicillin-resistant *Staphylococcus aureus*.
• Complicated Skin and Skin Structure Infections (cSSSI): Used in the manufacture of drugs indicated for treating deep-seated skin infections.
• Community-Acquired Bacterial Pneumonia (CABP): Key ingredient in antibiotics developed for treating serious respiratory tract infections.
• Research & Development: Serves as a reference standard and starting material for novel antibiotic research and new drug development programs.
• Generic Drug Manufacturing: Sourced by generic pharmaceutical companies for the production of cost-effective, high-quality antibiotic alternatives.

Basic Information

Product Name	Ceftaroline Fosamil Acetate Monohydrate
CAS No.	400827-55-6
Molecular Formula	C27H31N8O11S3 · C2H4O2 · H2O
Molecular Weight	762.81 g/mol
Synonyms	Ceftaroline Fosamil Acetate Hydrate; PPI-0903M Acetate; TAK-599 Acetate; (6R,7R)-7-[(2Z)-2-(2-Amino-1,3-thiazol-4-yl)-2-methoxyiminoacetamido]-3-[(4-(1-methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate; Ceftaroline Fosamil (Acetate); Ceftaroline Fosamil Acetate Salt; Ceftaroline Acetate Ester
EINECS	Contact for details

Quality Control

Our Ceftaroline Fosamil Acetate Monohydrate is manufactured under strict quality systems suitable for pharmaceutical applications. Each batch undergoes comprehensive analytical testing to ensure identity, purity, and potency meet stringent specifications. We provide full traceability and support regulatory filings with comprehensive documentation, including detailed Certificates of Analysis (COA) available upon request.

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 under dry, inert conditions to maintain stability and potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	2.0% - 4.0%
Acetic Acid Content	5.0% - 8.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 2.0%
Residual Solvents (GC)	Meets ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Bacterial Endotoxins	< 0.10 EU/mg
Microbial Enumeration	Meets Ph. Eur. 2.6.12 / USP <61>

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