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Merck

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

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About This Item

Empirical Formula (Hill Notation):
C17H18N2O6
CAS Number:
21829-25-4
Molecular Weight:
346.33
NACRES:
NA.24
PubChem Substance ID:
329823282
UNSPSC Code:
41116107
EC Number:
244-598-3
MDL number:
MFCD00057326

Product Name

Nifedipine, Pharmaceutical Secondary Standard; Certified Reference Material

InChI key

HYIMSNHJOBLJNT-UHFFFAOYSA-N

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

SMILES string

COC(=O)C1=C(C)NC(C)=C(C1c2ccccc2[N+]([O-])=O)C(=O)OC

grade

certified reference material
pharmaceutical secondary standard

agency

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

Quality Level

300

Gene Information

human ... CACNA1C(775), CACNA1D(776), CACNA1F(778), CACNA1S(779)

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Analysis Note

These secondary standards offer multi-traceability to the USP and EP (PhEur) primary standards, where they are available.

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.

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.

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 LRAA0488 in the slot below. This is an example certificate only and may not be the lot that you receive.

pictograms

Exclamation mark
GHS07

signalword

Warning

hcodes

H302

Hazard Classifications

Acute Tox. 4 Oral

Storage Class

11 - Combustible Solids

wgk

WGK 1

flash_point_f

Not applicable

flash_point_c

Not applicable

Certificates of Analysis (COA)

Search for Certificates of Analysis (COA) by entering the products Lot/Batch Number. Lot and Batch Numbers can be found on a product’s label following the words ‘Lot’ or ‘Batch’.

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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)
Yoshiki Yui
Drugs, 66 Spec No 1, 25-27 (2008-01-19)
It is thought that coronary artery spasm is involved in the pathogenesis of coronary artery disease in a large proportion of Japanese patients. However, large-scale trial data in Japanese patients were lacking. The JMIC-B (Japan Multicenter Investigation for Cardiovascular Diseases-B)
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
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)
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