Y0002369

Saxagliptin monohydrate

CRS, European Pharmacopoeia (EP) Reference Standard

• Synonym(s): Saxagliptin hydrate, (S)-3-Hydroxyadamantylglycine-L-cis-4,5-methanoprolinenitrile hydrate, BMS 477118, BMS 477118-11, BMS-477118, BMS-477118-11, BMS477118, BMS477118-11
• Empirical Formula (Hill Notation): C₁₈H₂₅N₃O₂ · H₂O
• CAS Number: 945667-22-1
• Molecular Weight: 333.43
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: pharmaceutical primary standard
• API family: saxagliptin
• manufacturer/tradename: EDQM
• application(s): pharmaceutical
• storage temp.: 2-8°C
• SMILES string: OC12CC([C@@H](C(N3[C@@H](C[C@]4([C@@]3(C4)[H])[H])C#N)=O)N)(CC(C5)C2)CC5C1.O
• InChI: 1S/C18H25N3O2.H2O/c19-8-13-2-12-3-14(12)21(13)16(22)15(20)17-4-10-1-11(5-17)7-18(23,6-10)9-17;/h10-15,23H,1-7,9,20H2;1H2/t10?,11?,12-,13+,14+,15-,17?,18?;/m1./s1
• InChI key: AFNTWHMDBNQQPX-NHKADLRUSA-N

Description

General description

This product is provided as delivered and specified by the issuing Pharmacopoeia. All information provided in support of this product, including SDS and any product information leaflets have been developed and issued under the Authority of the issuing Pharmacopoeia. For further information and support please go to the website of the issuing Pharmacopoeia.

Application

Saxagliptin monohydrate EP Reference standard, intended for use in laboratory tests only as specifically prescribed in the European Pharmacopoeia.

Biochem/physiol Actions

Saxagliptin (BMS-477118) is an orally active, highly potent and long-acting dipeptidyl peptidase IV inhibitor (human DPP-IV Ki = 0.9 nM; plasma DDP-IV inhibition = 87% 0.5-4h post 4 μmol/kg po. in normal rats) with therapeutic efficacy against type 2 diabetes in vivo (plasma glucose clearance = 28/43/61% post 0.3/1.0/3.0 μmol/kg po. in Zucker fa/fa rats).

Packaging

Unit quantity: 130mg. Subject to change. The product is delivered as supplied by the issuing Pharmacopoeia. For the current unit quantity, please visit the EDQM reference substance catalogue.

Other Notes

Sales restrictions may apply.

Safety Information

• Pictograms: GHS08
• Signal Word: Danger
• Hazard Statements: H317,H334,H361fd,H372
• Precautionary Statements: P202 - P260 - P264 - P280 - P302 + P352 - P308 + P313
• Hazard Classifications: Repr. 2 - Resp. Sens. 1 - Skin Sens. 1 - STOT RE 1
• Storage Class Code: 6.1C - Combustible acute toxic Cat.3 / toxic compounds or compounds which causing chronic effects
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable