PHR1599

Alendronate Sodium

Pharmaceutical Secondary Standard; Certified Reference Material

• 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

Properties

• 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)

Description

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

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Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H302
• Hazard Classifications: Acute Tox. 4 Oral
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable