Budesonide
Standard USP32/EP6.0
Formula C25H34O6
Mol. Weight 430.54
CAS 51333-22-3
Packing 1KG/TIN, 5KG/TIN
Origin China

USP32
Appearance White or almost white crystalline powder
Identification IR, UV
21-Acetate of budesonide Max 0.10%
11-Ketobudesonide Max 0.20%
16-Hydroxylprednisolone: Max 0.20%
D-Homobudesonide Max 0.10%
21-Dehydrobudesonide Max 0.10%
14,15-Dehydrobudesonide Max 0.10%
Any other individual impurity  Max 0.10%
Total specified impurities Max 0.40%
Total unspecified impurities Max 0.40%
Epimer A 44.0~51.0%
Methanol  Max 0.10%
Loss on drying  Max 0.30%
Assay(HPLC)) 98%~102%
Total aerobic microbial count Max 1000cfu/g
Total combined molds and yeasts Max 100cfu/g
 
APPLICATION
Budesonide is a glucocorticoid steroid for the treatment of asthma and non-infectious rhinitis (including hay fever and other allergies), and for treatment and prevention of nasal polyposis. In addition, it is used for Crohn's disease (inflammatory bowel disease).
Budesonide has a high first-pass metabolism. It has efficacy in the terminal ileum and the right colon.
Budesonide in comparison with prednisolone has been associated with fewer bone density losses, and, unlike other corticosteroids, has little influence on the hypothalamic-pituitary-adrenal axis, which also limits the need of tapering before discontinuation. Overall, it has a lower incidence of systemic manifestations than similar medications.

PACKAGE:
1KG/TIN, 5KG/TIN

STORAGE CONDITIONS:
Store in air-tight containers and hygienic conditions in a cool, dark place protected from light/Oxidation.