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.

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.

CAS no.51333-22-3
EINECS no.257-161-7
Molecular formulaC25H34O6
Molecular weight430.5 g/mol


It is used for the treatment of:
Inflammatory bowel disease
Allergic rhinitis
Eosinophilic esophagitis
Berger’s disease


AppearanceWhite or almost white, crystalline powder.
SolubilityPractically insoluble in water, Freely soluble in methylene chloride, sparingly soluble in alcohol (96%).
A) By IR AbsorptionThe IR spectrum of the sample should be concordant with that of a similar preparation of Budesonide standard.
B) By TLCThe principal spot of the test chromatogram should correspond to the principal spot of reference solution (a) at 254nm and 365nm.
C) By ChemicalThe colour should fade and a clear solution remains.
D) By ChemicalThe 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/w97.5 to 102.0
Residual Solvents
MethanolppmNot more than 1000
Dichloro MethaneppmNot more than 600
n-butyraldehydeppmNot more than 150
BenzeneppmNot more than 2
Dimethyl formamideppmNot more than 880

Fiber/HDPE drum.

Store in cool place. Keep container tightly closed in a dry and well-ventilated place.

WHO–GMP, Written Confirmation for EU and CEP.

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