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PHR1599

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Alendronate Sodium

Pharmaceutical Secondary Standard; Certified Reference Material

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Synonym(s):
Alendronate sodium trihydrate, 4-amino-1-hydroxy-1-phosphonobutyl phosphonic acid, monosodium, MK-217
Empirical Formula (Hill Notation):
C4H12NaNO7P2 · 3 H2O
CAS Number:
121268-17-5
Molecular Weight:
325.12
MDL number:
MFCD01748233
UNSPSC Code:
41116107
PubChem Substance ID:
329823499
NACRES:
NA.24

grade

certified reference material
pharmaceutical secondary standard

Quality Level

300

Agency

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

API family

alendronate

CofA

current certificate can be downloaded

packaging

pkg of 1 g

technique(s)

HPLC: suitable
gas chromatography (GC): suitable

application(s)

pharmaceutical (small molecule)

format

neat

storage temp.

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

InChI key

DCSBSVSZJRSITC-UHFFFAOYSA-M

Gene Information

human ... FDPS(2224)

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General description

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.

Biochem/physiol Actions

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

Analysis Note

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

Other Notes

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.

Footnote

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.

Recommended products

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.

Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H302

Hazard Classifications

Acute Tox. 4 Oral

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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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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