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PHR1599

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Alendronate Sodium

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

Alendronate sodium trihydrate, 4-amino-1-hydroxy-1-phosphonobutyl phosphonic acid, monosodium, MK-217

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About This Item

Formule empirique (notation de Hill):
C4H12NaNO7P2 · 3 H2O
Numéro CAS:
Poids moléculaire :
325.12
Numéro MDL:
Code UNSPSC :
41116107
ID de substance PubChem :
Nomenclature NACRES :
NA.24

Qualité

certified reference material
pharmaceutical secondary standard

Niveau de qualité

Agence

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

Famille d'API

alendronate

CofA (certificat d'analyse)

current certificate can be downloaded

Conditionnement

pkg of 1 g

Technique(s)

HPLC: suitable
gas chromatography (GC): suitable

Application(s)

pharmaceutical (small molecule)

Format

neat

Température de stockage

2-30°C

Chaîne SMILES 

[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

Clé InChI

DCSBSVSZJRSITC-UHFFFAOYSA-M

Informations sur le gène

human ... FDPS(2224)

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Description générale

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

Application

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.

Actions biochimiques/physiologiques

Alendronate sodium trihydrate is a bone resorption inhibitor; farnesyl diphosphate synthase inhibitor (IC50 = 460 nM); CD45 protein tyrosine phosphatase inhibitor.

Remarque sur l'analyse

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

Autres remarques

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.

Note de bas de page

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.

Produits recommandés

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.

Pictogrammes

Exclamation mark

Mention d'avertissement

Warning

Mentions de danger

Classification des risques

Acute Tox. 4 Oral

Code de la classe de stockage

11 - Combustible Solids

Classe de danger pour l'eau (WGK)

WGK 3

Point d'éclair (°F)

Not applicable

Point d'éclair (°C)

Not applicable


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Certificats d'analyse (COA)

Lot/Batch Number

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Retrouvez la documentation relative aux produits que vous avez récemment achetés dans la Bibliothèque de documents.

Consulter la Bibliothèque de documents

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)
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)
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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