Sitagliptin EP Impurity B

Name: Sitagliptin EP Impurity B
Brand: Vaqora Chemicals
SKU: VQ-023768

About Sitagliptin EP Impurity B

Vaqora Chemicals supplies Sitagliptin EP Impurity B, a pharmacopeial impurity of Sitagliptin registered under CAS number 486460-31-5. Formula C16H16F5N5O, molecular weight 389.32 g/mol. Alternative names: 2,5-Difluoro Sitagliptin and Sitagliptin - Impurity B.

The product is provided as a solid. Reference materials should be stored sealed and away from light and moisture, as specified on the accompanying COA. Handle it with standard laboratory precautions and appropriate personal protective equipment.

This Sitagliptin impurity supports analytical method development and validation (AMV), batch release testing and the impurity sections of ANDA and DMF filings. Typical end-use sectors are pharmaceutical manufacturing and academic and industrial research.

Available in 10 mg, 25 mg, 50 mg and 100 mg packs, Sitagliptin EP Impurity B is dispatched with a Certificate of Analysis (COA) to destinations worldwide.

Typical applications

Pharmacopeial method verification
Impurity profiling
QC release testing
ANDA / DMF filings

Industries

Related to Sitagliptin

View every impurity, metabolite and intermediate we list for Sitagliptin.

Sitagliptin impurities

Grade guides

Specifications & identifiers

Chemical identifiers
Product name	Sitagliptin EP Impurity B
Catalogue No.	VQ-023768
CAS Number	486460-31-5
IUPAC name	(3R)-3-amino-4-(2,5-difluorophenyl)-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]butan-1-one
Molecular formula	C₁₆H₁₆F₅N₅O
Molecular weight	389.32 g/mol
Exact mass	389.1275
Grade	Reference Standard
HSN code	38229090
InChIKey	ABTMQWQGGARRSK-LLVKDONJSA-N
SMILES	C1CN2C(=NN=C2C(F)(F)F)CN1C(=O)C[C@@H](CC3=C(C=CC(=C3)F)F)N
PubChem CID	9843297

Physical properties
Physical form	Solid
LogP (XLogP3)	0.6
H-bond donors / acceptors	1 / 9
TPSA	77 Å²

Documents

Safety Data Sheet (SDS)16-section GHS · on request Certificate of AnalysisTypical / batch COA · on request Specification sheetTDS / MOA · on request

Frequently asked questions

What is the CAS number of Sitagliptin EP Impurity B?

The CAS Registry Number of Sitagliptin EP Impurity B is 486460-31-5. It is also known as 2,5-Difluoro Sitagliptin, Sitagliptin - Impurity B, des-F-sitagliptin.

What is the molecular formula and molecular weight of Sitagliptin EP Impurity B?

Sitagliptin EP Impurity B has the molecular formula C16H16F5N5O and a molecular weight of 389.32 g/mol. Its IUPAC name is (3R)-3-amino-4-(2,5-difluorophenyl)-1-[3-(trifluoromethyl)-6,8-dihydro-5H-[1,2,4]triazolo[4,3-a]pyrazin-7-yl]butan-1-one.

What is Sitagliptin EP Impurity B used for?

Sitagliptin EP Impurity B is supplied as a characterised reference material related to Sitagliptin. It is used for analytical method development and validation (AMV), impurity profiling, stability studies and quality control, and in ANDA/DMF regulatory filings.

Which grade and pack sizes of Sitagliptin EP Impurity B can I order?

We supply Sitagliptin EP Impurity B in Reference Standard grade, in 10 mg, 25 mg, 50 mg, 100 mg packs. Larger bulk quantities and custom packing are quoted on request.

Do you provide a COA and SDS with Sitagliptin EP Impurity B?

Yes. Every lot of Sitagliptin EP Impurity B is shipped with a batch-specific Certificate of Analysis, and a 16-section GHS Safety Data Sheet is provided with the quotation and the shipment.

Can Sitagliptin EP Impurity B be shipped internationally?

Yes. We export Sitagliptin EP Impurity B worldwide by air and sea freight or express courier, on EXW, FOB, CIF, CFR or DAP Incoterms, with full export documentation.