PHR2079

Risedronate Impurity D

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): 3-Pyridylacetic acid hydrochloride, 3-Pyridineacetic acid hydrochloride
• Empirical Formula (Hill Notation): C₇H₇NO₂ · HCl
• CAS Number: 6419-36-9
• Molecular Weight: 173.60
• Beilstein: 3696630
• MDL number: MFCD00012819
• UNSPSC Code: 41116107
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• 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
• SMILES string: 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
• InChI key: XVCCOEWNFXXUEV-UHFFFAOYSA-N

Description

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

Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H315,H319,H335
• Precautionary Statements: P261 - P264 - P280 - P304 + P340 + P312 - P337 + P313 - P403 + P233
• Hazard Classifications: Eye Irrit. 2 - Skin Irrit. 2 - STOT SE 3
• Target Organs: Respiratory system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable