Product Info.
 
Teriparatide Acetate
CAS No. 52232-67-4
Molecular Formula C181H291N55O51S2
Molecular Weight 4117.72
Storage 2~8℃
Batch No. 20071119
Manufacturing Date 2007-11-17
Retest Date 2009-11-16
Sequence
TEST ITEMS SPECIFICATION RESULT
1 Appearance White slightly yellowish powder White powder
2 Identity 4117.72±2.0 4119.2
3 Solubility Soluble in water or 1% acetic acid at a concentration of ≥1mg/ml to give a clear, colorless solution conforms
4 Amino Acid Composition ± 10% conforms
5 Peptide Purity (By HPLC) ≥98% by area integration 99.0%
6 Related Substance(By HPLC) Total Impurities (%)≤2.0% Largest Single Impurity (%)≤ 1.0% 1.0% 0.5%
7 Acetate Content ≤15% 9.9%
8 Water Content (Karl Fischer) ≤8.0% 4.2%
9 Peptide Content(N determination) ≥80% 85.6%
10 Bacterial Endotoxins ≤ 500 EU/mg Conforms