Sitagliptin EP Impurity B
EP impurity reference standard
Specifications
- Product name
- Sitagliptin EP Impurity B
- CAS number
- 486460-31-5
- Catalogue number
C4X-114432- Molecular formula
- C16H16F5N5O
- Molecular weight
- 389.32
- Purity (HPLC)
- >95%
- Physical form
- White Solid
- Storage
- 2-8 °C
- SMILES
C1C(F)=CC(C[C@@H](N)CC(=O)N2CCN3C(=NN=C3C2)C(F)(F)F)=C(F)C=1- Available pack sizes
- 10 mg / 15 mg / 20 mg / 25 mg / 30 mg / 50 mg / 100 mg
- Lead time
- In stock
- Intended use
- Related substances and impurity testing, method development and validation, system suitability, QC release and stability testing.
Fields shown as — are not published for this item. They are left blank rather than filled with an estimate.
Description
Sitagliptin EP Impurity B (CAS 486460-31-5) is supplied by ImpurityLab as a European Pharmacopoeia impurity standard, identified by letter against the monograph for its parent substance. Catalogue number C4X-114432. It is related to Sitagliptin.
Parent drug substance. Sitagliptin. Browse the full Sitagliptin impurity and related compound standards held by ImpurityLab.
The material is issued against molecular formula C16H16F5N5O, molecular weight 389.32 g mol−1, physical form described as white solid.
Structural notation: C1C(F)=CC(C[C@@H](N)CC(=O)N2CCN3C(=NN=C3C2)C(F)(F)F)=C(F)C=1
Letter designations are assigned inside a monograph for one named substance. The same molecule can carry a different letter, or a different style of name, in another pharmacopoeia. Map the material from its structure — chemical name, formula and CAS — rather than from the letter alone.
Storage. Store at 2-8 °C. Allow the container to reach room temperature before opening so that moisture does not condense onto the material. Record the date of first opening on the label.
Pack sizes. 10 mg / 15 mg / 20 mg / 25 mg / 30 mg / 50 mg / 100 mg. Non-standard quantities are quoted on request, normally within two working days.
Documentation. Each lot is released with a certificate of analysis that states the assay method, the water content and the form as supplied. The safety data sheet is available with the same lot number. Quote catalogue number C4X-114432 when requesting either document.
Documentation
Documents are issued per lot. The COA you receive describes the lot that ships, not a representative sample.
Regulatory reference
EP Impurity B. Confirm the acceptance criterion, the reporting threshold and the edition of the monograph against your own method before use.
References are provided to help you map a standard to a pharmacopoeial method. Confirm the acceptance criteria against your own method before use.