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A synthetic analogue of vasopressin in which 3-mercaptopropionic acid replaces the cysteine residue at position 1 and D-arginine replaces the residue at position 8. An antidiuretic, it increases urine concentration and decreases urine prod ction, and is used (usually as the trihydrate of the acetic acid salt) to prevent and control excessive thirst, urination, and dehydration caused by injury, surgery, and certain medical conditions. It is also used in the diagnosis and treatment of cranial iabetes insipidus and in tests of renal function.
Test |
Specification |
Result |
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Appearance |
White or almost white fluffy powder |
conforms |
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Solubility
|
Soluble in water, in ethanol(96%) and in glacial acetic acid |
conforms |
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HPLC |
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. |
conforms |
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Amino acid analysis |
Amino acid limits
No more than the traces of other amino acids are present. |
Amino acid limits
conforms |
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Related Substances |
Unspecified impurity for each impurity: NMT0.5% |
0.30%(single largest impurity) |
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Purity(HPLC) |
NLT 98% |
99.18% |
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Water |
NMT 6.0% |
4.3% |
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Acetic acid |
3.0%~8.0% |
5.7% |
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MS |
1069.22±1.0 |
conforms |
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Bacterial Endotoxins |
Less than 500IU/mg |
conforms |
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Assay |
95.0%-105.0% (anhydrous and acetic acid free subtance) |
99.1% |
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Specific Optical Rotation (c=0.2, 1% aceticacid) |
-72° to -82° (anhydrous and acetic acid free substance) |
-77.5° |
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Residual solvent |
Methanol:NMT 3000ppm Acetonitrile:NMT 410 ppm Triethylamine:NMT 320 ppm |
conforms |
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