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PHR1290

Nifedipine

Name: Nifedipine
Brand: SIAL

Pharmaceutical Secondary Standard; Certified Reference Material

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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

PubChem Substance ID:

329823282

NACRES:

NA.24

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)

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Related Categories

Analytical Reference Standards

Certified Reference Materials

Pharmacopeia & Metrological Institute Standards

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.

related product

Product No.

Description

Pricing

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

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New spectrophotometric methods for the determination of nifedipine in pharmaceutical formulations

Rahman N and Azmi SNH

Acta Biochimica Polonica, 52(4), 915-915 (2005)

Determination of nifedipine in human plasma by high-performance liquid chromatography with electrochemical detection

Suzuki H, et al.

Journal of Chromatography. B, Biomedical Sciences and Applications, 341(1), 341-347 (1985)

Analysis of nifedipine-acebutolol hydrochloride binary combination in tablets using UV-derivative spectroscopy, capillary gas chromatography and high performance liquid chromatography.

A F el Walily

Journal of pharmaceutical and biomedical analysis, 16(1), 21-30 (1998-02-03)

Three methods are described for the simultaneous determination of nifedipine and acebutolol hydrochloride in combined pharmaceutical tablets. The first method depends on first-derivative ultraviolet spectrophotometry, with peak-to-base and zero-crossing measurements methods. The first derivative amplitudes at 400 and 352 nm

Role of oxidative stress in the development of vascular injury and its therapeutic intervention by nifedipine.

Sho-ichi Yamagishi et al.

Current medicinal chemistry, 15(2), 172-177 (2008-01-29)

Dihydropyridine-based calcium antagonists (DHPs) are widely used drugs for the treatment of hypertension and angina pectoris. We, along with others, have recently found that nifedipine, one of the most widely used DHPs, inhibits apoptotic cell death of endothelial cells (ECs)

Effectiveness of nifedipine tocolysis to facilitate external cephalic version: a systematic review.

C B Wilcox et al.

BJOG : an international journal of obstetrics and gynaecology, 118(4), 423-428 (2011-01-05)

The success rates of external cephalic version (ECV) are improved with the use of betamimetic tocolytics, but these drugs are associated with maternal side effects. To critically evaluate the effectiveness and advantages, if any, of nifedipine as a tocolytic for

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