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PHR1599

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Alendronat-Natrium

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(e):

Alendronat Natriumsalz Trihydrat, 4-Amino-1-hydroxy-1-phosphonobutylphosphonsäure, Mononatriumsalz, MK-217

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About This Item

Empirische Formel (Hill-System):
C4H12NaNO7P2 · 3 H2O
CAS-Nummer:
Molekulargewicht:
325.12
MDL-Nummer:
UNSPSC-Code:
41116107
PubChem Substanz-ID:
NACRES:
NA.24

Qualität

certified reference material
pharmaceutical secondary standard

Qualitätsniveau

Agentur

traceable to BP 830
traceable to Ph. Eur. Y0001727
traceable to USP 1012780

API-Familie

alendronate

Analysenzertifikat (CofA)

current certificate can be downloaded

Verpackung

pkg of 1 g

Methode(n)

HPLC: suitable
gas chromatography (GC): suitable

Anwendung(en)

pharmaceutical (small molecule)

Format

neat

Lagertemp.

2-30°C

SMILES String

[Na+].[H]O[H].[H]O[H].[H]O[H].NCCCC(O)(P(O)(O)=O)P(O)([O-])=O

InChI

1S/C4H13NO7P2.Na.3H2O/c5-3-1-2-4(6,13(7,8)9)14(10,11)12;;;;/h6H,1-3,5H2,(H2,7,8,9)(H2,10,11,12);;3*1H2/q;+1;;;/p-1

InChIKey

DCSBSVSZJRSITC-UHFFFAOYSA-M

Angaben zum Gen

human ... FDPS(2224)

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Allgemeine Beschreibung

Alendronate Sodium, an aminobisphosphonate compound, has been effectively used for the treatment of osteolysis, Paget′s disease and osteoporosis.
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

Anwendung

Alendronate Sodium may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and plasma samples by high-performance liquid chromatography method.
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.

Biochem./physiol. Wirkung

Natriumalendronat Trihydrat ist ein Knochenresorptionshemmer; Farnesyldiphosphatsynthase Inhibitor (IC50 = 460 nM); CD45 Protein-Tyrosin-Phosphataseinhibitor.

Hinweis zur Analyse

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

Sonstige Hinweise

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.

Fußnote

To see an example of a Certificate of Analysis for this material enter LRAC2083 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Empfohlene Produkte

Find a digital Reference Material for this product available on our online platform ChemisTwin® for NMR. You can use this digital equivalent on ChemisTwin® for your sample identity confirmation and compound quantification (with digital external standard). An NMR spectrum of this substance can be viewed and an online comparison against your sample can be performed with a few mouseclicks. Learn more here and start your free trial.

Piktogramme

Exclamation mark

Signalwort

Warning

H-Sätze

Gefahreneinstufungen

Acute Tox. 4 Oral

Lagerklassenschlüssel

11 - Combustible Solids

WGK

WGK 3

Flammpunkt (°F)

Not applicable

Flammpunkt (°C)

Not applicable


Hier finden Sie alle aktuellen Versionen:

Analysenzertifikate (COA)

Lot/Batch Number

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In der Dokumentenbibliothek finden Sie die Dokumentation zu den Produkten, die Sie kürzlich erworben haben.

Die Dokumentenbibliothek aufrufen

Determination of alendronate sodium by ion chromatography with refractive index detection.
Han YHR and Qin XZ
Journal of Chromatography A, 719(2), 345-352 (1996)
High-performance liquid chromatography method for determining alendronate sodium in human plasma by detecting fluorescence: application to a pharmacokinetic study in humans.
Yun MH, et al.
Journal of Pharmaceutical and Biomedical Analysis, 40(1), 168-172 (2006)
A fast and simple spectrofluorometric method for the determination of alendronate sodium in pharmaceuticals.
Ezzati JND, et al.
BioImpacts, 4(1), 39-42 (2014)
Hüseyin Abdik et al.
Molecular biology reports, 46(1), 763-776 (2018-12-07)
Bisphosphonate-induced osteonecrosis of the jaw (BIONJ) is a commonly encountered side effect of Bisphosphonates (BPs). Although certain aspects of BIONJ have been studied, the effects of BPs on the proliferation, differentiation, and maintenance of dental stem cells (DSC) in way

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