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10 Gram |
Negotiable |
Leuprolide acetate Leuprolide Leuprolide acetate best price
Our advantages for Leuprolide acetate :
1. High quality standard higher than USP/EP
2. Produced in GMP workshop according to GMP regulations
3. Very competitive price
Our company SINOWAY advantages :
1) ISO 9001:2015 & SGS audited supplier
2) Established in 1987, exported 35 years in pharmaceutical /cosmetic raw materials and health care products.
3) We are members of SINOSURE ,we can do better payment terms of T.T 30 days .
4) We have warehouse in USA for quickly shipment .
5) We can do DDP ,CIP ,CIF ,FOB different terms .
Product Name |
Leuprolide Acetate |
Standard |
EP7 |
CAS. No. |
74381-53-6 |
Batch No. |
20210701 |
Molecular Formula |
C59H84N16O12 |
Molecular Weight |
1209 |
Manufacturing Date |
Jan.,2021 |
Retest Date |
Dec.,2023 |
Storage |
NMT 30℃ |
||
Sequence
|
TEST ITEMS |
SPECIFICATION |
RESULT |
|
1 |
Appearance |
White powder |
Conforms |
2 |
Solubility |
Soluble in water or 1% acetic acid at a concentration of ≥1mg/ml to give a clear, colorless solution |
Conforms |
3 |
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 |
Conforms
Conforms
0.95 0.99 1.05 2.02 1.02 0.98 1.01 present |
4 |
Specific Optical Rotation |
-38.0~-42.0° [a]20D(c=1,1% HAc) |
-40.1° |
5 |
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% |
6 |
Acetate Content(By HPLC) |
4.7~9.0% |
7.5% |
7 |
Water Content(Karl Fischer) |
≤5.0% |
1.5% |
8 |
Sulphate ash |
≤0.3% |
Conforms |
9 |
Bacterial Endotoxins |
≤16.7 IU/mg |
Conforms |
10 |
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 |
11 |
Assay(By Anhydrous, Acetic Acid-free ) |
97.0~103.0% |
99.5% |
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