Sitagliptin Phosphate EP Impurity B

About Sitagliptin Phosphate EP Impurity B

Sitagliptin Phosphate EP Impurity B is a pharmacopeial impurity of Sitagliptin carrying the CAS registry number 1345822-87-8. The compound has the formula C16H19F5N5O5P, corresponding to a molecular weight of 487.32 g/mol. It is also known as Sitagliptin Phosphate Hydrate - Impurity B or 4-Desfluoro Sitagliptin.

The product is provided as a solid. Keep the vial tightly closed, protected from light and humidity, at the temperature stated on the Certificate of Analysis. Handle it with standard laboratory precautions and appropriate personal protective equipment.

Pharmaceutical QC and development laboratories use this impurity standard of Sitagliptin to develop and validate HPLC methods, to set specification limits and to document impurity profiles in ANDA and DMF submissions. It is used across pharmaceutical manufacturing and academic and industrial research.

We offer Sitagliptin Phosphate EP Impurity B in 10 mg, 25 mg, 50 mg and 100 mg packs with a batch-specific COA, and ship to customers 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 Phosphate EP Impurity B
Catalogue No.	VQ-028051
CAS Number	1345822-87-8
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;phosphoric acid
Molecular formula	C₁₆H₁₉F₅N₅O₅P
Molecular weight	487.32 g/mol
Exact mass	487.1044
Grade	Reference Standard
HSN code	38229090
InChIKey	UOKMPNRCGWVMBY-RFVHGSKJSA-N
SMILES	C1CN2C(=NN=C2C(F)(F)F)CN1C(=O)C[C@@H](CC3=C(C=CC(=C3)F)F)N.OP(=O)(O)O
PubChem CID	71253039

Physical properties
Physical form	Solid
H-bond donors / acceptors	4 / 13
TPSA	155 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 Phosphate EP Impurity B?

The CAS Registry Number of Sitagliptin Phosphate EP Impurity B is 1345822-87-8. It is also known as 4-Desfluoro Sitagliptin, Sitagliptin EP Impurity B, Sitagliptin Phosphate Hydrate - Impurity B, 4-Desfluoro Sitagliptin.

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

Sitagliptin Phosphate EP Impurity B has the molecular formula C16H19F5N5O5P and a molecular weight of 487.32 g/mol.

What is Sitagliptin Phosphate EP Impurity B used for?

Sitagliptin Phosphate 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 Phosphate EP Impurity B can I order?

We supply Sitagliptin Phosphate 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 Phosphate EP Impurity B?

Yes. Every lot of Sitagliptin Phosphate 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 Phosphate EP Impurity B be shipped internationally?

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