| Size | Price | Stock | Qty |
|---|---|---|---|
| 5mg |
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| 10mg |
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| Other Sizes |
| Targets |
Budesonide impurity C does not have a defined biological target as a standalone compound; it is a process-related impurity rather than a pharmacologically active agent. Its parent compound, Budesonide, is an inhaled glucocorticoid and an orally active glucocorticoid receptor agonist. Budesonide binds to and activates the glucocorticoid receptor, modulating the transcription of genes involved in inflammation and immune responses. The impurity is characterized and quantified in pharmaceutical quality control to ensure the safety and efficacy of budesonide formulations.
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|---|---|
| ln Vitro |
In CV-1 cells, budesonide preferentially binds to the human glucocorticoid receptor (hGR; EC50=45.7 pM) as opposed to the mineralocorticoid receptor (EC50=7,620 pM). In macrophages (RAW 264.7 cells), budesonide (30 min before LPS) inhibits the activation of the NLRP3 inflammasome by LPS (100 ng/mL) + ATP (5 mM)[2].
As an impurity standard, Budesonide impurity C does not have intrinsic in vitro biological activity that is characterized for pharmacological purposes. It is used as an analytical reference standard in quality control testing of budesonide pharmaceutical formulations. The parent compound, Budesonide, is a potent glucocorticoid receptor agonist with well-characterized in vitro anti-inflammatory activity. The impurity is typically evaluated using analytical methods such as HPLC and LC-MS to ensure it is present within acceptable limits in drug products. |
| ln Vivo |
Budesonide impurity C is not used for in vivo pharmacological activity assessment as a standalone compound. Its primary application is as an analytical reference standard for the quality control of budesonide pharmaceutical formulations. The parent compound, Budesonide, is an inhaled glucocorticoid with well-characterized in vivo anti-inflammatory activity used in the treatment of asthma and COPD. The impurity is monitored in drug products to ensure patient safety and product quality.
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| Enzyme Assay |
In vitro assays for Budesonide impurity C typically involve analytical methods for its detection and quantification rather than biological activity assessment. The compound is characterized using HPLC, LC-MS, and other analytical techniques to determine its purity and concentration in pharmaceutical formulations. For quality control purposes, the impurity is quantified relative to the active pharmaceutical ingredient. The compound serves as an analytical reference standard for method development, method validation, and quality control applications. Standard analytical procedures are employed for its characterization.
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| Cell Assay |
Budesonide impurity C is not used in cell-based assays for biological activity assessment. Its primary application is as an analytical reference standard for quality control in pharmaceutical manufacturing. The compound is used in the development and validation of analytical methods for the detection and quantification of impurities in budesonide drug products. Standard analytical methods such as HPLC and LC-MS are employed for its characterization. The impurity is monitored to ensure it is within acceptable limits in final drug products.
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| Animal Protocol |
Budesonide impurity C is not used in animal studies as a pharmacological agent. Its primary application is as an analytical reference standard for quality control in pharmaceutical manufacturing. The compound is used in the development and validation of analytical methods for the detection and quantification of impurities in budesonide drug products. The impurity is monitored in pharmaceutical formulations to ensure product quality and patient safety. No in vivo animal studies are conducted with this impurity as a test compound.
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| ADME/Pharmacokinetics |
Budesonide impurity C has a molecular weight of 430.53 g/mol and a molecular formula of C₂₅H₃₄O₆. It is a process-related impurity of the synthetic glucocorticoid budesonide. The compound is formed during the synthesis of budesonide and can be detected in pharmaceutical formulations. Its characterization is essential for quality control in drug manufacturing. The compound is typically stored under conditions recommended for analytical reference standards.
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| Toxicity/Toxicokinetics |
Budesonide impurity C is an impurity standard intended for research and analytical use only and is not approved for human therapeutic applications. As an analytical reference standard, it is used in trace quantities in quality control testing and does not present significant toxicological concerns at these levels. The parent compound, Budesonide, has been extensively studied for its safety and efficacy as a pharmaceutical agent. Standard laboratory safety precautions should be observed when handling Budesonide impurity C.
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| References |
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| Additional Infomation |
Budesonide impurity C (CAS#: 1040085-99-1) has a molecular formula of C₂₅H₃₄O₆ and a molecular weight of 430.53 g/mol. It is also known as D-Homobudesonide or Budesonide D-homo analog. It is a process-related impurity of the synthetic glucocorticoid budesonide. Budesonide is an inhaled glucocorticoid and orally active glucocorticoid receptor agonist. This impurity is characterized for quality control in pharmaceutical manufacturing. This compound is not a drug and is strictly an analytical reference standard.
|
| Molecular Formula |
C25H34O6
|
|---|---|
| Molecular Weight |
430.533868312836
|
| Exact Mass |
430.235
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| CAS # |
1040085-99-1
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| PubChem CID |
118989637
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| Appearance |
White to off-white solid powder
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| Density |
1.3±0.1 g/cm3
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| Boiling Point |
607.0±55.0 °C at 760 mmHg
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| Flash Point |
204.6±25.0 °C
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| Vapour Pressure |
0.0±3.9 mmHg at 25°C
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| Index of Refraction |
1.592
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| LogP |
2.56
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| Hydrogen Bond Donor Count |
2
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| Hydrogen Bond Acceptor Count |
6
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| Rotatable Bond Count |
3
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| Heavy Atom Count |
31
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| Complexity |
862
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| Defined Atom Stereocenter Count |
8
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| SMILES |
CCCC1O[C@@H]2C[C@H]3[C@@H]4CCC5=CC(=O)C=C[C@@]5([C@H]4[C@H](C[C@@]3(C(=O)[C@@]2(O1)CO)C)O)C
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| InChi Key |
DRLZLIQUOCVRLM-PINIVEOHSA-N
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| InChi Code |
InChI=1S/C25H34O6/c1-4-5-20-30-19-11-17-16-7-6-14-10-15(27)8-9-23(14,2)21(16)18(28)12-24(17,3)22(29)25(19,13-26)31-20/h8-10,16-21,26,28H,4-7,11-13H2,1-3H3/t16-,17-,18-,19+,20?,21+,23-,24-,25+/m0/s1
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| Chemical Name |
(4aR,4bS,5S,6aS,7aR,10aR,11aS,11bS)-5-hydroxy-7a-(hydroxymethyl)-4a,6a-dimethyl-9-propyl-5,6,10a,11,11a,11b,12,13-octahydro-4bH-chryseno[2,3-d][1,3]dioxole-2,7-dione
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| HS Tariff Code |
2934.99.9001
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| Storage |
Powder -20°C 3 years 4°C 2 years In solvent -80°C 6 months -20°C 1 month |
| Shipping Condition |
Room temperature (This product is stable at ambient temperature for a few days during ordinary shipping and time spent in Customs)
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| Solubility (In Vitro) |
DMSO: ≥ 100 mg/mL (~232.3 mM)
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|---|---|
| Solubility (In Vivo) |
Solubility in Formulation 1: ≥ 2.5 mg/mL (5.81 mM) (saturation unknown) in 10% DMSO + 40% PEG300 + 5% Tween-80 + 45% Saline (add these co-solvents sequentially from left to right, and one by one), Clear solution.
For example, if 1 mL of working solution is to be prepared, you can add 100 μL of DMSO stock solution (25.0 mg/mL) to 400 μL of PEG300 and mix well; then add 50 μL of Tween-80 and mix well; finally add 450 μL of physiological saline and adjust the volume to 1 mL. Preparation of saline: Dissolve 0.9 g of sodium chloride in 100 mL ddH₂ O to obtain a clear solution. Solubility in Formulation 2: ≥ 2.5 mg/mL (5.81 mM) (saturation unknown) in 10% DMSO + 90% (20% SBE-β-CD in Saline) (add these co-solvents sequentially from left to right, and one by one), Clear solution. For example, if 1 mL of working solution is to be prepared, you can add 100 μL of DMSO stock solution (25.0 mg/mL) to 900 μL of 20% SBE-β-CD saline and mix well. Preparation of 20% SBE-β-CD in Saline (4°C，1 week): Dissolve 2 g SBE-β-CD in 10 mL saline to obtain a clear solution. (Please use freshly prepared in vivo formulations for optimal results.) |
| Preparing Stock Solutions | 1 mg | 5 mg | 10 mg | |
| 1 mM | 2.3227 mL | 11.6136 mL | 23.2272 mL | |
| 5 mM | 0.4645 mL | 2.3227 mL | 4.6454 mL | |
| 10 mM | 0.2323 mL | 1.1614 mL | 2.3227 mL |
*Note: Please select an appropriate solvent for the preparation of stock solution based on your experiment needs. For most products, DMSO can be used for preparing stock solutions (e.g. 5 mM, 10 mM, or 20 mM concentration); some products with high aqueous solubility may be dissolved in water directly. Solubility information is available at the above Solubility Data section. Once the stock solution is prepared, aliquot it to routine usage volumes and store at -20°C or -80°C. Avoid repeated freeze and thaw cycles.
Calculation results
Working concentration： mg/mL；
Method for preparing DMSO stock solution： mg drug pre-dissolved in μL DMSO (stock solution concentration mg/mL). Please contact us first if the concentration exceeds the DMSO solubility of the batch of drug.
Method for preparing in vivo formulation:：Take μL DMSO stock solution, next add μL PEG300, mix and clarify, next addμL Tween 80, mix and clarify, next add μL ddH2O，mix and clarify.
(1) Please be sure that the solution is clear before the addition of next solvent. Dissolution methods like vortex, ultrasound or warming and heat may be used to aid dissolving.
(2) Be sure to add the solvent(s) in order.
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