If this product has an expiration or retest date, it will be shown on the Certificate of Analysis (COA, CofA). If there is no retest or expiration date listed on the product's COA, we do not have suitable stability data to determine a shelf life. For these products, the only date on the COA will be the release date; a retest, expiration, or use-by-date will not be displayed.
For all products, we recommend handling per defined conditions as printed in our product literature and website product descriptions. We recommend that products should be routinely inspected by customers to ensure they perform as expected.
For products without retest or expiration dates, our standard warranty of 1 year from the date of shipment is applicable.
For more information, please refer to the Product Dating Information document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/418/501/product-dating-information-06-25-mk.pdf
About This Item
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SMILES string
FC(F)(F)c1[n]2c(nn1)CN(CC2)C(=O)C[C@H](N)Cc3c(cc(c(c3)F)F)F.[P](=O)(O)(O)O.O
InChI
1S/C16H15F6N5O.H3O4P.H2O/c17-10-6-12(19)11(18)4-8(10)3-9(23)5-14(28)26-1-2-27-13(7-26)24-25-15(27)16(20,21)22;1-5(2,3)4;/h4,6,9H,1-3,5,7,23H2;(H3,1,2,3,4);1H2/t9-;;/m1../s1
InChI key
GQPYTJVDPQTBQC-KLQYNRQASA-N
grade
certified reference material, pharmaceutical secondary standard
agency
traceable to Ph. Eur. Y0001812, traceable to USP 1612903
API family
sitagliptin
form
powder
CofA
current certificate can be downloaded
packaging
pkg of 1 g
technique(s)
HPLC: suitable, gas chromatography (GC): suitable
application(s)
pharmaceutical (small molecule)
storage temp.
2-8°C
Quality Level
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This Item | |||
|---|---|---|---|
| application(s) pharmaceutical (small molecule) | application(s) pharmaceutical (small molecule) | application(s) pharmaceutical (small molecule) | application(s) pharmaceutical (small molecule) |
| technique(s) HPLC: suitable, gas chromatography (GC): suitable | technique(s) - | technique(s) - | technique(s) HPLC: suitable, gas chromatography (GC): suitable |
| form powder | form - | form - | form - |
| Quality Level 300 | Quality Level - | Quality Level - | Quality Level 300 |
| grade certified reference material, pharmaceutical secondary standard | grade pharmaceutical primary standard | grade pharmaceutical primary standard | grade certified reference material, pharmaceutical secondary standard |
| storage temp. 2-8°C | storage temp. 2-8°C | storage temp. 2-8°C | storage temp. 2-30°C |
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.
Sitagliptin phosphate, a dipeptidyl peptidase IV (DPPIV) inhibitor, is an antidiabetic drug used in the treatment of diabetes type II mellitus.
Application
- 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)
Analysis Note
Other Notes
comparable product
related product
signalword
Warning
hcodes
Hazard Classifications
Eye Irrit. 2 - STOT RE 2
target_organs
Liver
Storage Class
11 - Combustible Solids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
Certificates of Analysis (COA)
Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.
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How is shipping temperature determined? And how is it related to the product storage temperature?
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Products may be shipped at a different temperature than the recommended long-term storage temperature. If the product quality is sensitive to short-term exposure to conditions other than the recommended long-term storage, it will be shipped on wet or dry-ice. If the product quality is NOT affected by short-term exposure to conditions other than the recommended long-term storage, it will be shipped at ambient temperature. As shipping routes are configured for minimum transit times, shipping at ambient temperature helps control shipping costs for our customers. For more information, please refer to the Storage and Transport Conditions document: https://www.sigmaaldrich.com/deepweb/assets/sigmaaldrich/marketing/global/documents/316/622/storage-transport-conditions-mk.pdf
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