Product Info.
 
Leuprorelin Acetate
CAS No. 53714-56-0
Molecular Formula C59H84N16O12
Molecular Weight 1209.43
Storage 2℃--8℃
Batch No. 20070924
Manufacturing Date 2007-09-24
Retest Date 2009-09-24
Sequence pGlu-His-Trp-Ser-Tyr-D-Leu-Leu-Arg-Pro-NHEt
TEST ITEMS SPECIFICATION RESULT
1 Appearance White powder Conforms
2 Solubility Souble in water or 1% acetic acid at a concentration of≥1mg/ml to give a clear, colorless solution Conforms
3 Identity Monoisotopic Mass: 1209.43±1.0 1209.8
4 Specific optical rotation -38.0~-42.0° [α]20D(c=1,1%HAc) -40.0°
5 Amino acid Composition Ser: present Glu: 0.85~1.1 Pro: 0.85~1.1 Leu: 0.85~1.1 Tyr: 0.85~1.1 His: 0.85~1.1 Arg: 0.85~1.1 Trp: present 0.88 0.91 1.01 2.06 1.00 0.98 0.95 present
6 Peptide Purity(By HPLC) ≥98.0% by area integration 99.3%
7 RelatedSubstance(BYHPLC) Total Impurities(%)≤2.0% Largest Single Impurity(%)≤0.5% 0.7% 0.4%
8 Acetate Content 4.7%~9.0% 8.8%
9 Water Content(Karl Fischer) ≤5.0% 2.0%
10 Bacterial Endotoxins ≤16.7IU/mg Conforms
11 Peptide Content ≥80.0% 90.2%
12 Assay(By Anhydrous,Acetic Acid-free) 97.0~103.0% 100.5%