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PHR1290

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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
EC Number:
244-598-3
MDL number:
MFCD00057326
UNSPSC Code:
41116107
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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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

1463508

Nifedipine, United States Pharmacopeia (USP) Reference Standard

N0750000

Nifedipine, European Pharmacopoeia (EP) Reference Standard

N0750010

Nifedipine impurity A, European Pharmacopoeia (EP) Reference Standard

1463600

Nifedipine Nitrophenylpyridine Analog, United States Pharmacopeia (USP) Reference Standard

N0750015

Nifedipine impurity B, European Pharmacopoeia (EP) Reference Standard

1463701

Nifedipine Nitrosophenylpyridine Analog, United States Pharmacopeia (USP) Reference Standard

BP462

Nifedipine, British Pharmacopoeia (BP) Reference Standard

BP866

Dimethyl 2,6-dimethyl-4-(2-nitrosophenyl)-3,5-pyridinedicarboxylate, British Pharmacopoeia (BP) Reference Standard

Pictograms

Exclamation mark
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

Choose from one of the most recent versions:

Certificates of Analysis (COA)

Lot/Batch Number
LRAC9625
LRAC2936
LRAA9087
LRAA0488

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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)
New spectrophotometric methods for the determination of nifedipine in pharmaceutical formulations
Rahman N and Azmi SNH
Acta Biochimica Polonica, 52(4), 915-915 (2005)
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
Ryuichi Morishita et al.
Drugs, 66 Spec No 1, 31-33 (2008-01-19)
Useful drug therapy for inhibiting the extension of an aortic aneurysm or promoting its involution has not yet been established. Hypertension is a known risk factor for extension of an aortic aneurysm. However, on a cellular level it is believed
Norio Taira
Drugs, 66 Spec No 1, 1-3 (2008-01-19)
Nifedipine was synthesized by Bayer Germany in 1966 and considered for clinical use as a coronary vasodilator in patients with angina pectoris. Japanese investigators played a great part in the pre-clinical and clinical development of nifedipine. Professor Hashimoto demonstrated that
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