Hydrocortisone

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1 Kilogram	Negotiable

1 Kilogram

Negotiable

Hydrocortisone powder Hydrocortisone micro Hydrocortisone base

1. GMP AVALIABLE ;

2. IN STOCK

3. FAST REPLY

QUALIFED ; EFFICIENCY; RESPONSIBLE

ITEM	SPECIFICATIONS	RESULTS
Appearance	White or almost white crystalline powder	White crystalline powder
Identification	A:IR spectrum of the sample should conform to that of the reference standard.	Conforms
Identification	B.HPLC：In the item of related substances test ,the retention time and size of the principal peak in the test solution is accordant with that of reference solution (C)	Conforms
Specific optical rotation	+162～+168 °	+163.9°
Loss on drying	≤1.0%	0.1%
Related substances	Impurity A ≤ 0.2%	0.03%
	Impurity B ≤ 0.2%	Not detected
	Impurity C ≤ 0.5%	0.03%
	Impurity D ≤ 0.5%	Not detected
	Impurity E ≤ 0.5%	Not detected
	Impurity F ≤ 0.3%	Not detected
	Impurity G ≤ 0.4%	0.11%
	Impurity H ≤ 0.15%	Not detected
	Impurity I ≤ 0.5%	Not detected
	Impurity N ≤ 0.15%	Not detected
	Individual unknown impurity ≤ 0.10%	0.08%
	Total impurities ≤2.0%	0.41%
Assay	97.0% ~103.0% of C₂₁H₃₀O₅ calculated by dry basis	100.3%
Conclusion: It conforms to the requirements of EP10.