PHR2079
利塞膦酸钠相关化合物D
Pharmaceutical Secondary Standard; Certified Reference Material
别名:
3-吡啶乙酸 盐酸盐, 吡啶-3-乙酸 盐酸盐
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关于此项目
经验公式（希尔记法）:
C7H7NO2 · HCl
化学文摘社编号:
分子量:
173.60
NACRES:
NA.24
UNSPSC Code:
41116107
Beilstein/REAXYS Number:
3696630
MDL number:
SMILES string
Cl[H].OC(=O)Cc1cccnc1
InChI key
XVCCOEWNFXXUEV-UHFFFAOYSA-N
InChI
1S/C7H7NO2.ClH/c9-7(10)4-6-2-1-3-8-5-6;/h1-3,5H,4H2,(H,9,10);1H
grade
certified reference material, pharmaceutical secondary standard
API family
risedronate
CofA
current certificate can be downloaded
packaging
pkg of 50 mg
mp
161-163 °C (lit.)
application(s)
pharmaceutical
format
neat
storage temp.
2-30°C
Quality Level
General description
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.
Analysis Note
These secondary standards offer multi-traceability to the USP and EP 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.
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.
signalword
Warning
hcodes
Hazard Classifications
Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3
target_organs
Respiratory system
存储类别
11 - Combustible Solids
wgk
WGK 3
flash_point_f
Not applicable
flash_point_c
Not applicable
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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