ITEMS

SPECIFICATION

Appearance

White powder

Solubility

Soluble in water or 1% acetic acid at a

concentration of ≥1mg/ml to give a clear,

colorless solution

Identity

A. IR

Same with the reference spectrum of Leuprolide

B. HPLC

Same with the reference solution

C. Amino Acid Analysis

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

Specific Optical Rotation

-38.0~-42.0° [a]20D(c=1,1% HAc)

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%

Acetate Content(By HPLC)

4.7~9.0%

Water Content(Karl Fischer)

≤5.0%

Sulphate ash

≤0.3%

Bacterial Endotoxins

≤16.7 IU/mg

Residual Organic Solvents

Acetonitrile ≤0.041%(By GC)

DMF ≤0.088%(By GC)

MEOH ≤0.3%(By GC)

TFA ≤0.1%(By HPLC)

Assay(By Anhydrous, Acetic Acid-free )

97.0~103.0%