PHR1290

Nifedipine

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): Nifedipine, 1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic acid dimethyl ester
• Empirical Formula (Hill Notation): C₁₇H₁₈N₂O₆
• CAS Number: 21829-25-4
• Molecular Weight: 346.33
• EC Number: 244-598-3
• MDL number: MFCD00057326
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823282
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to BP 462; traceable to Ph. Eur. N0750000; traceable to USP 1463508
• API family: nifedipine
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-30°C
• SMILES string: COC(=O)C1=C(C)NC(C)=C(C1c2ccccc2[N+]([O-])=O)C(=O)OC
• InChI: 1S/C17H18N2O6/c1-9-13(16(20)24-3)15(14(10(2)18-9)17(21)25-4)11-7-5-6-8-12(11)19(22)23/h5-8,15,18H,1-4H3
• InChI key: HYIMSNHJOBLJNT-UHFFFAOYSA-N
• Gene Information: human ... CACNA1C(775) , CACNA1D(776) , CACNA1F(778) , CACNA1S(779)

Description

General description

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.
Nifedipine belongs to the class of calcium channel antagonist drugs and finds a wide use as an antihypertensive and an antianginal agent. It can also be used as a coronary vasodilator.

Application

Nifedipine may be used as a pharmaceutical reference standard for the determination of the analyte in pharmaceutical formulations and plasma samples by spectrophotometry and chromatography techniques.

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 (PhEur) 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 LRAA0488 in the 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: H302
• Hazard Classifications: Acute Tox. 4 Oral
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 1
• Flash Point(F): Not applicable
• Flash Point(C): Not applicable