97% up by HPLC USP Leuprolide Acetate 74381-53-6

Product Information

Product name

Leuprolide Acetate

CAS No.

74381-53-6

Molecular Formula

C59H84N16O12

Molecular Weight

1269.65

Molecular Structure

Quality Standard

97% up by HPLC, USP

Appearance

White powder

COA of Leuprolide acetate

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%

Usage