Product Name: Omarigliptin (MK-3102)
Synonyms: MK-3102;(2R,3S,5R)-2-(2,5-difluorophenyl)-5-(2-(Methylsulfonyl)pyrrolo[3,4-c]pyrazol-5(2H,4H,6H)-yl)tetrahydro-2H-pyran-3-aMine;MK-3012;(2S,3R,5S)-2-(2,5-Difluorophenyl)-5-[2-(Methylsulfonyl)-2,6-dihydropyrrolo[3,4-c]pyrazol-5(4H)-yl]tetrahydro-2H-pyran-3-aMine (MK-3102 enantioMer);(2R,3S,5R)-2-(2,5-Difluorophenyl)-5-[2-(methylsulfonyl)-2,6-dihydropyrrolo[3,4-c]pyrazol-5(4H)-yl]tetrahydro-2H-pyran-3-amine;OMarigliptin;OMarigliptin (MK-3102);2R,3S,5R)-2-(2,5-Difluorophenyl)-5-[2-(methylsulfonyl)-2,6-dihydropyrrolo[3,4-c]pyrazol-5(4H)-yl]tetrahydro-2H-pyran-3-amine MK3102
CAS: 1226781-44-7
MF: C17H20F2N4O3S
MW: 398.43
EINECS: 682-558-0
Boiling point: 529.4±60.0 °C
Omarigliptin/MK-3102 is a potent, reversible, and competitive inhibitor of dipeptidyl peptidase 4 (DPP-4; IC50 = 1.6 nM; Ki = 0.8 nM). It is selective for DPP-4 over 168 proteas es, ion channels, and enzymes with IC50 values greater than 10 μM in all assays. MK-3102 significantly reduces blood glucose levels in a dose-dependent manner in vivo in rats. It also has a long half-life (11 and 22 hours in rat and dog, respectively) making it suitable for once weekly dosing. Clinical trials demonstrate that formulations containing MK-3102 reduce plasma glucose and HbA1c in patients with type 2 diabetes mellitus (T2DM).
Omarigliptin is a potent and selective dipeptidyl peptidase 4 (DPP-4) inhibitor to be used as treatment for type 2 diabetes
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BATCH NO.: HF171202 |
QUANTITY:75.1kg |
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---MFG. DATE : May., 2, 2024 |
SPECIFICATION: As required |
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REP. DATE : May.4, 2024 |
EXP. DATE : May.3, 2024 |
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ITEMS |
STANDARDS |
RESULTATE |
|
Voorkoms |
White or off-white crystalline powder |
Off-white crystalline powder |
|
Identifikasie |
By IR |
Voldoen |
|
RT under chirality should complies |
Voldoen |
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Chloride: it gives a reaction of chloride |
Voldoen |
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Water |
3.0%~4.5% |
3.4% |
|
Melting Point- |
198.0~202.0ºC |
199.8~200.5ºC |
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Residue on Ignition |
≤0,2% |
0.08% |
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Heavy Metals |
≤10ppm |
Voldoen |
|
Related Substances |
Individual Impurities:≤0.5% |
0.15% |
|
Total Impurities:≤1.0% |
0.22% |
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Residual Solvent |
≤0.06% |
0.0066% |
|
≤0,5% |
0.015% |
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≤0,5% |
0.0013% |
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E.E |
≥99,0% |
99.6% |
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Assay (on dry basis) |
98.0%~102.0% |
101.2% |
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Conclusion:It complies to prescribed enterprise standard. |
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Aanvaarde betaling Geldeenheid: USD;
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Gesproke taal: Engels.
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