PHR3270

Sitagliptin Impurity B (Ph. Eur.)

certified reference material, pharmaceutical secondary standard

• Synonym(s): (3R)-3-Amino-4-(2,5-difluorophenyl)-1-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl]butan-1-one, 4-Desfluoro Sitagliptin
• Empirical Formula (Hill Notation): C₁₆H₁₉F₅N₅O₅P
• CAS Number: 1345822-87-8
• Molecular Weight: 487.32
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• API family: sitagliptin
• packaging: pkg of 40 mg
• application(s): pharmaceutical
• storage temp.: 2-8°C

Description

General description

Pharmaceutical secondary standards for application in quality control provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards

Application

These Secondary Standards are qualified as Certified Reference Materials. These are suitable for use in several analytical applications including but not limited to pharma release testing, pharma method development for qualitative and quantitative analyses, food and beverage quality control testing, and other calibration requirements.

Analysis Note

These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available.

Other Notes

This Certified Reference Material (CRM) is produced and certified in accordance with ISO 17034 and ISO/IEC 17025. All information regarding the use of this CRM can be found on the certificate of analysis.

Footnote

To see an example of a Certificate of Analysis for this material enter LRAA6959(changes by product) in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Safety Information

• Storage Class Code: 13 - Non Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable