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 |
|
|