16α-Hydroxyprednisolone 13951-70-7

99% up by HPLC

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Product Information

Product name	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
CAS No.	13951-70-7
Molecular Formula	C21H28O6
Molecular Weight	376.45
Quality Standard	99% up by HPLC
Appearance	White to off white crystalline powder

COA

ANALYSIS	SPECIFICATION	RESULTS
Appearance	White to off white crystalline powder	Off white crystalline powder
Solubility	Sparingly soluble in Methanol.(0.1 g of sample in 10 ml of methanol)	Conforms
Loss on drying	≤0.5%	0.07%
Specific optical rotation	+71° ~ +79°	+71.7°
Relative substance (HPLC)	1,2-Dihydronot ≤ 0.15%	0.07%
	Single impurity ≤ 0.2%	0.11%
	16α-Hydroxy prednisolone 21-acetate ≤0.10%	ND
	Total impurity ≤1.0%	0.18%
Assay(HPLC)	≥99.0%	100.2%
Conclusion	The sample complies with the Requirements of In Enterprise Specifications.

Usage

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.