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.
No matter the quantity you need, our exceptional quality and service will make ExSyn your supplier of choice! If you need any additional information or SDS, please contact us.
Blown Castor Oil (15-17 Poise) is a modified grade of Castor oil. The “15-17 Poise” specification refers to its viscosity range, indicating a medium-viscosity blown oil suitable for industrial applications requiring improved body, tackiness, and elasticity compared to regular castor oil.
Dimethylaminoethanol (DMAE) is a is a tertiary amine that is ethanolamine having two N-methyl substituents. It is clear & colourless to pale yellow liquid with ammoniacal odor. DMAE is stable at room temperature and is completely miscible with water as well as organic solvents such as alcohols and ethers. It decomposes at high temperatures. It is a versatile chemical intermediate primarily used as a curing agent for polyurethane foams and epoxy resins.
1,4,7-Trimethyl-1,4,7-triazonane (Me₃TACN) is a valuable macrocyclic tridentate ligand derived from 1,4,7-triazacyclononane. In Me₃TACN, each nitrogen atom is substituted with a methyl group, which significantly modifies its steric and electronic properties. Me₃TACN is widely used as a ligand in coordination chemistry due to its ability to form stable complexes with transition metals such as Cu, Ni, Fe, Mn, and Zn.
Adenosine is a naturally occurring purine nucleoside composed of adenine and ribose, present in all living cells. It plays a vital role in biochemical processes such as energy transfer (ATP/ADP), signal transduction, and regulation of physiological functions, and is widely used in pharmaceutical applications.
Methyl-2-Methoxy-5-Sulfamoyl Benzoate (MSMB) is a sulfur containing organic building block acting as a chemical intermediate. MSMB contains ester and sulfamoyl functional groups, which make it useful as a pharmaceutical and fine-chemical intermediate.
Imidazolidinyl urea is a widely used antimicrobial preservative in the cosmetic and personal care industry. It is a formaldehyde-releasing compound that effectively inhibits the growth of bacteria, yeast, and molds, thereby extending the shelf life of formulations. Due to its broad-spectrum efficacy and cost-effectiveness, it is commonly used in rinse-off and leave-on products within regulated concentration limits.
Phosphorodiamidites are a unique class of phosphorus-based compounds characterized by one P–O bond and two P–N moieties. 2-Cyanoethyl tetraisopropylphosphorodiamidite plays a crucial role in solid-phase oligonucleotide synthesis. Beyond their application as synthetic precursors for oligonucleotides, phosphorodiamidites have also been reported as valuable starting materials for the synthesis of industrially relevant polymers and flame-resistant materials, including adhesives, coatings, and laminates.
Ferric maltol is an oral iron complex composed of ferric iron (Fe³⁺) chelated with maltol, designed to improve iron absorption while reducing common gastrointestinal side effects associated with traditional iron salts. It is primarily used in the management of iron deficiency with better tolerability.
Phosphatidylcholine (PC) is one of the most important phospholipids derived from soya lecithin and represents a key structural component of cell membranes. Phosphatidylcholine 90% refers to a highly purified grade where the PC content is enriched to around 90% through specialized extraction and purification steps.