ITEMS
|
SPECIFICATION
|
RESULT
|
Appearance
|
White powder
|
Conforms
|
Solubility
|
Soluble in water or 1% acetic acid at a
concentration of ≥1mg/ml to give a clear,
colorless solution
|
Conforms
|
Identity
|
IR
Same with the reference spectrum of Leuprolide
|
Conforms
|
HPLC
Same with the reference solution
|
Conforms
|
Amino Acid Analysis
|
Conforms
|
|
Ser: Present
Glu: 0.85~1.1
Pro: 0.85~1.1
Leu: 1.80~2.2
Tyr: 0.85~1.1
His: 0.85~1.1
Arg: 0.85~1.1
Trp: Present
|
Present
0.99
1.05
2.02
1.02
0.98
1.01
present
|
Specific Optical Rotation
|
-38.0~-42.0° [a]20D(c=1,1% HAc)
|
-40.1°
|
RelatedSubstance
(By HPLC)
|
Total Impurities(%)≤2.5%
acetyl-leuprolide≤1.0%
D-His-leuprolide≤0.5%
L-Leu6-leuprolide≤0.5%
D-Ser-leuprolide≤0.5%
Any other Impurity≤0.5%
|
0.17%
Conforms
Conforms
Conforms
Conforms
0.17%
|
Acetate Content(By HPLC)
|
4.7~9.0%
|
7.5%
|
Water Content(Karl Fischer)
|
≤5.0%
|
1.5%
|
Sulphate ash
|
≤0.3%
|
Conforms
|
Bacterial Endotoxins
|
≤16.7 IU/mg
|
Conforms
|
Residual Organic Solvents
|
Acetonitrile ≤0.041%(By GC)
DMF ≤0.088%(By GC)
MEOH ≤0.3%(By GC)
TFA ≤0.1%(By HPLC)
|
Conforms
Conforms
Conforms
Conforms
|
Assay(By Anhydrous, Acetic Acid-free )
|
97.0~103.0%
|
99.5%
|