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PHR2079

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Risedronate Impurity D

Pharmaceutical Secondary Standard; Certified Reference Material

Synonyme(s) :

3-Pyridylacetic acid hydrochloride, 3-Pyridineacetic acid hydrochloride

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About This Item

Formule empirique (notation de Hill):
C7H7NO2 · HCl
Numéro CAS:
Poids moléculaire :
173.60
Numéro Beilstein :
3696630
Numéro MDL:
Code UNSPSC :
41116107
Nomenclature NACRES :
NA.24

Qualité

certified reference material
pharmaceutical secondary standard

Niveau de qualité

Famille d'API

risedronate

CofA (certificat d'analyse)

current certificate can be downloaded

Conditionnement

pkg of 50 mg

Pf

161-163 °C (lit.)

Application(s)

pharmaceutical

Format

neat

Température de stockage

2-30°C

Chaîne SMILES 

Cl[H].OC(=O)Cc1cccnc1

InChI

1S/C7H7NO2.ClH/c9-7(10)4-6-2-1-3-8-5-6;/h1-3,5H,4H2,(H,9,10);1H

Clé InChI

XVCCOEWNFXXUEV-UHFFFAOYSA-N

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Description générale

Risedronate Impurity D is an impurity of risedronate, which is a new generation pyridinyl bisphosphonate, effectively used in the treatment of Paget′s disease of bone. It is also used for the treatment of skeletal disorders since it inhibits osteoclast-mediated bone resorption and modulates bone metabolism.

Application

Risedronate may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using reversed-phase ion-pair high-performance liquid chromatographic 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.

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 LRAB8929 in the Documents slot below. This is an example certificate only and may not be the lot that you receive.

Pictogrammes

Exclamation mark

Mention d'avertissement

Warning

Mentions de danger

Classification des risques

Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3

Organes cibles

Respiratory system

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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Consulter la Bibliothèque de documents

Stability indicating ion?pair HPLC method for the determination of risedronate in a commercial formulation
Aluoch A, et al.
Journal of Liquid Chromatography and Related Technologies, 27(17), 2799-2813 (2004)
Development and validation of a reversed-phase ion-pair high-performance liquid chromatographic method for the determination of risedronate in pharmaceutical preparations
Kyriakides D and Panderi I
Analytica Chimica Acta, 584(1), 153-159 (2007)

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