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PHR2079

Supelco

Risedronate Impurity D

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym(s):

3-Pyridylacetic acid hydrochloride, 3-Pyridineacetic acid hydrochloride

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About This Item

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

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

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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.

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Description
Pricing

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Risedronate Related Compound A, United States Pharmacopeia (USP) Reference Standard

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Risedronate Related Compound B, United States Pharmacopeia (USP) Reference Standard

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Risedronate Related Compound C, United States Pharmacopeia (USP) Reference Standard

1604610

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Y0001558

Risedronate impurity A, European Pharmacopoeia (EP) Reference Standard

Y0001540

Risedronate impurity E, European Pharmacopoeia (EP) Reference Standard

Y0001541

Risedronate sodium 2.5-hydrate, European Pharmacopoeia (EP) Reference Standard

PHR1888

Risedronate Sodium, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2078

Risedronate Impurity C, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2075

Risedronate Related Compound A, Pharmaceutical Secondary Standard; Certified Reference Material

PHR2077

Risedronate Related Compound C, Pharmaceutical Secondary Standard; Certified Reference Material

Pictograms

Exclamation mark
GHS07

Signal Word

Warning

Hazard Statements

H315,H319,H335

Hazard Classifications

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

Target Organs

Respiratory system

WGK

WGK 3

Flash Point(F)

Not applicable

Flash Point(C)

Not applicable

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAD4950
LRAB8929

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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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