Specification No. M09
Mafenide acetate
4-(Aminomethyl)-benzenesulfonamide monoacetate
Molecular Formula: C7H10N2O2S .C2H4O2
Molecular Weight: 246.29
C.A.S. No.: [13009-99-9]
Description: White to almost white crystalline substance.
| Tests: | |
| Identification: a) I.R. spectrum USP28<197> b) TLC |
|
| Melting range: | 162 - 171 °C |
| The range between beginning and end of melting does not exceed 4 °C. | |
| pH of 10 % (w/v) aqueous solution: | 6.4 - 6.8, USP28<791> |
| Water (K.F. titration): | max. 1.0 % USP28<921> |
| Heavy metals: | max. 0.002 % USP28<231> |
| Residue on ignition: |
max. 0.2 % USP28<281> |
| Selenium: |
max. 0.003 % USP28<291> |
| Total sum of impurities (TLC): | max. 1.0 % USP28, p.1160 |
| Any individual impurity (TLC): | max. 0.5 % USP28, p.1160 |
| Organic volatile impurities: (Method V) |
must pass USP 26, <467> |
| Assay (UV spectrofotometry, calculation based on anhydrous substance): |
98.0 - 102.0 % USP28, p.1160-61 |
| Shelf life: 2 years | |
Conforms to the specification set out by USP 24, Supplement 2
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