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Pharmacopeial Impurities (EP / USP / BP)

Sitagliptin EP Impurity B

Reference StandardAvailable on request

Sitagliptin EP Impurity B (CAS 486460-31-5) supplier Zemixal. Lab and bulk packs, batch COA, fast global delivery. Catalogue no. ZX-022784.

Pack sizes
Sitagliptin EP Impurity B chemical structure
CAS number486460-31-5
FormulaC16H16F5N5O
Molar mass389.32 g/mol
Physical formSolid
HS code38229090
InChIKeyABTMQWQGGARRSK-LLVKDONJSA-N
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

About Sitagliptin EP Impurity B

Zemixal lists Sitagliptin EP Impurity B for laboratories that identify, quantify or control Sitagliptin and its related substances. Key data (Reference Standard): CAS 486460-31-5, formula C16H16F5N5O and molar mass 389.32 g/mol. It is handled as a solid.

Use cases we see most often

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

Standard pack sizes are 10 mg, 25 mg, 50 mg and 100 mg, and custom quantities are quoted on request. Each lot travels with a certificate of analysis with characterisation data. Send an enquiry through the quote panel and you get a formal offer with Incoterms and delivery time.

Reference standards for Sitagliptin

See every impurity, metabolite and related compound we list for this API.

Sitagliptin standards

Typical uses

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

Applications

Grade guides

Specifications and identifiers

Specifications of Sitagliptin EP Impurity B
Product nameSitagliptin EP Impurity B
Catalogue numberZX-022784
CAS number486460-31-5
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 formulaC16H16F5N5O
Molar mass389.32 g/mol
Exact mass389.1275
GradeReference Standard
Physical formSolid
XLogP30.6
H-bond donors / acceptors1 / 9
Topological polar surface area77 Ų
HS code38229090
InChIKeyABTMQWQGGARRSK-LLVKDONJSA-N
SMILESC1CN2C(=NN=C2C(F)(F)F)CN1C(=O)C[C@@H](CC3=C(C=CC(=C3)F)F)N
PubChem CID9843297
Synonyms2,5-Difluoro Sitagliptin, Sitagliptin - Impurity B, des-F-sitagliptin, Desfluorositagliptin

Lot values are stated on the batch certificate of analysis. Ask for a typical COA with your quotation.

Safety and GHS hazards

No GHS classification is on file for this item. Handle it as an unknown laboratory chemical and request the SDS with your quotation.

Pack sizes

Pack sizes of Sitagliptin EP Impurity B
10 mgQuoted on request
25 mgQuoted on request
50 mgQuoted on request
100 mgQuoted on request

Need a different size? Bulk drums and custom packing are quoted on request through the quote form on this page.

Questions about Sitagliptin EP Impurity B

Which CAS number identifies Sitagliptin EP Impurity B?
Sitagliptin EP Impurity B is registered under CAS 486460-31-5. You may also see it listed as 2,5-Difluoro Sitagliptin, Sitagliptin - Impurity B, des-F-sitagliptin. Our catalogue number for this item is ZX-022784.
What are the formula and molar mass of Sitagliptin EP Impurity B?
For Sitagliptin EP Impurity B, its formula is C16H16F5N5O and its molar mass is 389.32 g/mol. The systematic (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. InChIKey ABTMQWQGGARRSK-LLVKDONJSA-N lets you match it in any structure database.
How is Sitagliptin EP Impurity B used in pharmaceutical QC?
Sitagliptin EP Impurity B is a characterised reference material linked to Sitagliptin. Laboratories use it to identify and quantify this impurity during method development and validation, stability work, batch release testing and regulatory submissions.
What grade and pack sizes are available for Sitagliptin EP Impurity B?
This listing is Reference Standard grade. Standard packs are 10 mg, 25 mg, 50 mg, 100 mg. Larger quantities and custom packing can be quoted on request.
Which documents come with Sitagliptin EP Impurity B?
Each lot ships with a batch certificate of analysis and a 16-section GHS safety data sheet. A typical COA or specification sheet can be shared with the quotation before you order.
Can Zemixal ship Sitagliptin EP Impurity B to my country?
Yes. Sitagliptin EP Impurity B ships worldwide by express courier, air cargo or sea freight, quoted on the Incoterm you prefer, with full export documents.

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