|
BUDESONIDE |
| Product Name |
: |
Budesonide BP/EP/USP |
| Chemical Name |
: |
2-bromo-2-nitropropane-1,3-diol |
| CAS Number |
: |
51333-22-3 |
| Chemical Formula |
: |
C25H34O6 |
| Molecular Mass |
: |
430.54 g/mol |
| Therapeutic Category |
: |
Antasthma |
| Test |
Specification |
| Identification |
IR Spectrum of the sample dispersed, shall be concordant with that of the working standard. |
| Loss On Drying |
NMT 0.5 % w/w |
| Assay on dried basis by HPLC |
Between 98.0 % & 102.0 % w/w, calculated with reference to the dried substance. |
| Related Substances by HPLC |
Individual impurity:- NMT 0.5% Total impurities :- NMT 1.5% |
| Characteristics |
A white or almost white crystalline powder, practically insoluble in water, freely soluble in methylene chloride, sparingly soluble in alcohol. |
| Additional Tests |
Acetonitrile NMT 410 ppm Butyraldehyde NMT 1000 ppm Methanol NMT 1000 ppm Acetone NMT 3000 ppm Disopropyl ether NMT 3000 ppm |
| Epimer A |
Between 40.0% & 51.0% w/w |
| Methanol (By GC) |
NMT 0.1 % |
| Particle Size |
90.0 % < 10 µm 99.5 % < 20 µm |
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