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Key Documents

PHR1599

Supelco

Alendronate Sodium

Pharmaceutical Secondary Standard; Certified Reference Material

Sinonimo/i:

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

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About This Item

Formula empirica (notazione di Hill):
C4H12NaNO7P2 · 3 H2O
Numero CAS:
Peso molecolare:
325.12
Numero MDL:
Codice UNSPSC:
41116107
ID PubChem:
NACRES:
NA.24

Grado

certified reference material
pharmaceutical secondary standard

Livello qualitativo

agenzia

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

Famiglia di API

alendronate

CdA

current certificate can be downloaded

Confezionamento

pkg of 1 g

tecniche

HPLC: suitable
gas chromatography (GC): suitable

applicazioni

pharmaceutical (small molecule)

Formato

neat

Temperatura di conservazione

2-30°C

Stringa SMILE

[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
DCSBSVSZJRSITC-UHFFFAOYSA-M

Informazioni sul gene

human ... FDPS(2224)

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Descrizione generale

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

Applicazioni

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.

Azioni biochim/fisiol

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

Risultati analitici

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

Altre note

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.

Nota a piè di pagina

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.

Prodotti consigliati

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.

Pittogrammi

Exclamation mark

Avvertenze

Warning

Indicazioni di pericolo

Classi di pericolo

Acute Tox. 4 Oral

Codice della classe di stoccaggio

11 - Combustible Solids

Classe di pericolosità dell'acqua (WGK)

WGK 3

Punto d’infiammabilità (°F)

Not applicable

Punto d’infiammabilità (°C)

Not applicable


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Certificati d'analisi (COA)

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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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