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

Methyl tert-butyl ether ≤ 5000ppm

51ppm

Conclusion

The sample conforms to EP11.0

Usage