Sitagliptin Phosphate
SIAL/PHR1857 - Pharmaceutical Secondary Standard; Certified Reference Material
Synonym: Sitagliptin phosphate monohydrate; 7-
CAS Number: 654671-77-9
Empirical Formula (Hill Notation): C16H15F6N5O · H3PO4 · H2O
Molecular Weight: 523.32
Linear Formula: C16H15F6N5O · H3PO4 · H2O
Product Type: Chemical
| agency | traceable to Ph. Eur. Y0001812 |
| traceable to USP 1612903 | |
| application(s) | pharmaceutical (small molecule) |
| CofA | current certificate can be downloaded |
| form | powder |
| grade | certified reference material |
| pharmaceutical secondary standard | |
| InChI | 1S/C16H15F6N5O.H3O4P.H2O/ |
| InChI key | GQPYTJVDPQTBQC-KLQYNRQASA |
| packaging | pkg of 1 g |
| Quality Level | 300  |
| storage temp. | 2-8°C |
| technique(s) | gas chromatography (GC): suitable |
| HPLC: suitable |
| Analysis Note: | These secondary standards offer multi-traceability to the USP, EP and BP primary standards, where they are available. |
| Application: | This pharmaceutical secondary standard can also be used as follows:• Development of a reversed-phase high-performance liquid chromatographic (RP-HPLC) method to determine sitagliptin phosphate and metformin hydrochloride in combined pharmaceutical formulations • 19F nuclear magnetic resonance (19F-NMR) spectroscopy-based quantitative analysis of sitagliptin phosphate and validation of the method using proton 1H-NMR • Determination of sitagliptin phosphate in tablet dosage forms using RP-HPLC and following International Conference on Harmonization (ICH) guidelines • Simultaneous estimation of sitagliptin and four of its impurities in pharmaceutical formulations by micellar electrokinetic chromatography (MEKC) following a quality-by-design (QbD) approach • Multi-analysis of sitagliptin phosphate, metformin hydrochloride, pioglitazone hydrochloride, gliclazide, glibenclamide, and repaglinide in pharmaceutical tablets using reversed phase-liquid chromatography (RP-LC) |
| Footnote: | To see an example of a Certificate of Analysis for this material enter LRAC0251 in the Documents slot below. This is an example certificate only and may not be the lot that you receive. |
| General description: | An anti-diabetic (antihyperglycemic) drug of the dipeptidyl peptidase-4 (DPP-4) class. Inhibition of the enzyme DPP-4 is thought to increase Glucagon-like peptide-1 (GLP-1) which inhibits glucagon release, stimulates insulin release and lowers blood glucose. |
| General description: | 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. 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. Sitagliptin phosphate, a dipeptidyl peptidase IV (DPPIV) inhibitor, is an antidiabetic drug used in the treatment of diabetes type II mellitus. |
| RIDADR | NONH for all modes of transport |
| WGK Germany | WGK 3 |
| Flash Point(F) | Not applicable |
| Flash Point(C) | Not applicable |
| Storage Temp. | 2-8°C |
| UNSPSC | 12352200 |