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Key Documents

PHR1290

Supelco

Nifedipine

Pharmaceutical Secondary Standard; Certified Reference Material

Sinônimo(s):

Nifedipine, 1,4-Dihydro-2,6-dimethyl-4-(2-nitrophenyl)-3,5-pyridinedicarboxylic acid dimethyl ester

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About This Item

Fórmula empírica (Notação de Hill):
C17H18N2O6
Número CAS:
Peso molecular:
346.33
Número CE:
Número MDL:
Código UNSPSC:
41116107
ID de substância PubChem:
NACRES:
NA.24

grau

certified reference material
pharmaceutical secondary standard

Nível de qualidade

Agency

traceable to BP 462
traceable to Ph. Eur. N0750000
traceable to USP 1463508

família API

nifedipine

Certificado de análise (CofA)

current certificate can be downloaded

técnica(s)

HPLC: suitable
gas chromatography (GC): suitable

aplicação(ões)

pharmaceutical (small molecule)

formato

neat

temperatura de armazenamento

2-30°C

cadeia de caracteres SMILES

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

chave InChI

HYIMSNHJOBLJNT-UHFFFAOYSA-N

Informações sobre genes

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Descrição geral

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.

Aplicação

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.

Nota de análise

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

Outras notas

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.

Nota de rodapé

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.

Pictogramas

Exclamation mark

Palavra indicadora

Warning

Frases de perigo

Classificações de perigo

Acute Tox. 4 Oral

Código de classe de armazenamento

11 - Combustible Solids

Classe de risco de água (WGK)

WGK 1

Ponto de fulgor (°F)

Not applicable

Ponto de fulgor (°C)

Not applicable


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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
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
Corey B Toal et al.
Blood pressure, 21 Suppl 1, 3-10 (2012-07-06)
Calcium-channel blockers (CCBs) constitute a diverse group of compounds but are often referred to as a single homogeneous class of drug and the clinical responses indiscriminately summarized. Even within the dihydropyridine subgroup, there are significant differences in formulations, pharmacokinetics, durations

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