Table 1 Release analytics of Teriparatide product
From: Numaswitch: an efficient high-titer expression platform to produce peptides and small proteins
Property | Specification | Measured |
|---|---|---|
Identity (4117.7 Da) | 1030.4 [M + 4H]+4 | 1030.4 [M + 4H]+4 |
Peptide mapping (aa) | 23–30, 23–34, 5–22, 5–19 | confirmed |
Purity | (≥ 95) % | 99.6% |
Net/gross weight | > 80 | 88.7% |
Acetate/TFA/Cl | > 95% Acetate | 96/3/1 (mol%) |
Endotoxins | < 5 EU/mg | < 0.4 EU/mg |
rHCP | < 500 ng/mg | < 100 ng/mg |
rHCD | < 200 pg/mg | < 10 pg/mg |
Functionality | As WHO standard | Confirmed |