PHR1599

Alendronate Sodium

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonyme(s) : Alendronate sodium trihydrate, 4-amino-1-hydroxy-1-phosphonobutyl phosphonic acid, monosodium, MK-217
• Formule empirique (notation de Hill): C₄H₁₂NaNO₇P₂ · 3 H₂O
• Numéro CAS: 121268-17-5
• Poids moléculaire : 325.12
• Numéro MDL: MFCD01748233
• Code UNSPSC : 41116107
• ID de substance PubChem : 329823499
• Nomenclature NACRES : NA.24

Propriétés

• Qualité: certified reference material; pharmaceutical secondary standard
• Niveau de qualité: 300
• 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)

Description

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.

Informations sur la sécurité

• Pictogrammes: GHS07
• Mention d'avertissement: Warning
• Mentions de danger: H302
• 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