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Sinoway Industrial Co.Ltd.
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Product name
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16α-Hydroxyprednisolone;
16α-Hydroxy prednisolone;
16alpha-Hydroxyprednisolone；
11a,16b,17,21-Tetrahydroxy-pregna-1,4-diene-3,20-dione；
budesonide intermediate；
16Α-Hydroxy-Prednisolone；
Budesonide Hydrolysate；
Budesonide Impurity A
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CAS No.
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13951-70-7
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Molecular Formula
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C21H28O6
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Molecular Weight
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376.45
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Quality Standard
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99% up by HPLC
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Appearance
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White to off white crystalline powder
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ANALYSIS
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SPECIFICATION
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RESULTS
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Appearance
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White to off white crystalline powder
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Off white crystalline powder
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Solubility
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Sparingly soluble in Methanol.(0.1 g of sample in 10 ml of methanol)
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Conforms
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Loss on drying
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≤0.5%
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0.07%
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Specific optical rotation
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+71° ~ +79°
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+71.7°
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Relative substance
(HPLC)
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1,2-Dihydronot ≤ 0.15%
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0.07%
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Single impurity ≤ 0.2%
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0.11%
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16α-Hydroxy prednisolone 21-acetate ≤0.10%
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ND
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Total impurity ≤1.0%
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0.18%
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Assay(HPLC)
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≥99.0%
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100.2%
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Conclusion
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The sample complies with the Requirements of In Enterprise Specifications.
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16α-Hydroxyprednisolone is an intermediate in the production of glucocorticoid APIs, serving as a crucial raw material for the synthesis of approved ned-type drugs (such as triamcinolone, budesonide, ciclesonide, and desonide). Ned-type drugs belong to inhaled glucocorticoids, characterized by local application, low dosage, strong local anti-inflammatory effects, and minimal systemic side effects. They are widely used in the treatment of refractory asthma and inflammation. |
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