INTRODUCTION
Budesonide is in a class of medications called corticosteroids. It works by decreasing inflammation (swelling) in the digestive tract of people who have Crohn’s disease or ulcerative colitis. or in the kidney of people with nephropathy.
MANUFACTURE
It is manufactured by the reaction of 16α-hydroxyprednisolone (11β,16α,17α,21-tetrahydroxypregna-1,4-diene-3,20-dione) with butyraldehyde in dioxane, using perchloric acid as catalyst.
| Synonym | 16,17-Butylidenebis(oxy)-11,21-dihydroxypregna-1,4-diene-3,20-dione |
| CAS no. | 51333-22-3 |
| EINECS no. | 257-161-7 |
| Molecular formula | C25H34O6 |
| Molecular weight | 430.5 g/mol |
| Structure |  |
APPLICATIONS
| It is used for the treatment of: |
|---|
| Asthma |
| Inflammatory bowel disease |
| Allergic rhinitis |
| Eosinophilic esophagitis |
| Berger’s disease |
SPECIFICATIONS… (EP)
| Test | Unit | Specification |
|---|---|---|
| Appearance | – | White or almost white, crystalline powder. |
| Solubility | – | Practically insoluble in water, Freely soluble in methylene chloride, sparingly soluble in alcohol (96%). |
| Identification | ||
| A) By IR Absorption | – | The IR spectrum of the sample should be concordant with that of a similar preparation of Budesonide standard. |
| B) By TLC | – | The principal spot of the test chromatogram should correspond to the principal spot of reference solution (a) at 254nm and 365nm. |
| C) By Chemical | – | The colour should fade and a clear solution remains. |
| D) By Chemical | – | The solution should turn blue. |
| Loss on drying | % | Not more than 0.5 |
| Epimer A (Second Peak) | % | 40.0 to 51.0 |
| Related Substances (By HPLC) | ||
| Impurity A | % | Not more than 0.2 |
| Impurity D | % | Not more than 0.2 |
| Impurity K | % | Not more than 0.2 |
| Impurity L | % | Not more than 0.2 |
| Unspecified impurities | % | Not more than 0.10 |
| Total impurities | % | Not more than 0.5 |
| Assay (By HPLC) (on dried substance) | % w/w | 97.5 to 102.0 |
| Residual Solvents | ||
| Methanol | ppm | Not more than 1000 |
| Dichloro Methane | ppm | Not more than 600 |
| n-butyraldehyde | ppm | Not more than 150 |
| Benzene | ppm | Not more than 2 |
| Dimethyl formamide | ppm | Not more than 880 |
PACKING
Fiber/HDPE drum.
STORAGE
Store in cool place. Keep container tightly closed in a dry and well-ventilated place.
CERTIFICATION
WHO–GMP, Written Confirmation for EU and CEP.
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