Fosfomycin Trometamol 78964-85-9

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Product Information

Product name	Fosfomycin Trometamol
CAS No.	78964-85-9
Molecular Formula	C4H11NO3.C3H7O4P
Molecular Weight	259.196
Quality Standard	99% up by HPLC, EP, Document:CEP
Appearance	White or almost white powder, hygroscopic

COA

Test Items	Specifications	Results
Appearance	White or almost white powder,hygroscopic	White powder,hygroscopic
Identification	IR: Complies	Complies
Specific Rotation (anhydrous substance)	-13.5°~ -12.5°	-13.1°
Acidity(pH)	3.5 ~5.5	4.5
Assay (anhydrous substance)	98.0% -102.0%	99.6%
Water	≤0.5%	0.06%
Related Substance	Impurity A ≤ 0.3%	0.03%
	Impurity B ≤ 0.3%	0.01%
	Impurity C ≤ 0.1%	ND
	Impurity D ≤ 0.1%	ND
	Unspecified Impurities ≤ 0.1%	<0.05%
	Total Impurities ≤ 0.5%	0.07%
Phosphates	≤ 500ppm	< 500ppm
Residual Solvents	Methanol ≤ 3000ppm	372ppm
Residual Solvents	Methyl tert-butyl ether ≤ 5000ppm	51ppm
Conclusion	The sample conforms to EP11.0

Usage

Fosfomycin Trometamol is the tromethamine (trometamol) salt of Fosfomycin. It is a broad-spectrum, bactericidal antibiotic API. Its unique mechanism of action inhibits bacterial cell wall synthesis at an early stage, making it effective against many multidrug-resistant strains with a low cross-resistance profile.

Primary Application:

Fosfomycin Trometamolis primarily used in the formulation of single-dose oral sachets or granules for the treatment of uncomplicated lower Urinary Tract Infections (UTIs), such as acute cystitis.