| Test | Specification |
Appearance (EP.curr.ed) | White or off-white powder |
| Solubility | Freely soluble in water, slightly soluble in MeOH and in EtOH ，almost insoluble in ether. |
HPLC (EP.curr.ed) | The principal peak in the chromatogram obtained with the test solution is similar in retention time to principal peak in the chromatogram obtained with the reference solution. |
IR (EP.curr.ed) | The spectrum obtained is similar to the reference spectrum. |
Amino acid analysis (EP.curr.ed) | ±10% of theoretical |
Acetic acid (EP.curr.ed) | NMT 8.0% |
water (EP.curr.ed) | NMT 7.0% |
Bacterial Endotoxins (EP.curr.ed) | Less than 5EU/mg |
Assay (EP.curr.ed) | 97%-103%(anhydrous and acetic acid free substance) |
Residual solvent Methanol Acetonitrile Triethylamine |
NMT 3000ppm NMT 410 ppm NMT 320 ppm |
Triptorelin Acetate is as an anticoagulant for adult elective percutaneous coronary intervention (PCI)