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Amlodipine besylate

Pharmaceutical Secondary Standard; Certified Reference Material

Synonym: 2-[(2-Aminoethoxy)-methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylic acid 3-ethyl 5-methyl ester benzene sulfonate, Norvasc

  • CAS Number 111470-99-6

  • Empirical Formula (Hill Notation) C20H25ClN2O5 · C6H5SO3H

  • Molecular Weight 567.05

  •  MDL number MFCD00887594

  •  PubChem Substance ID 329823196

  •  NACRES NA.24

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Properties

Related Categories A-B, Analytical Standards, Analytical/Chromatography, Pharmaceutical Secondary Standards, Pharmacopeia & Metrological Institutes Standards More...
Quality Level   300
grade   certified reference material
  pharmaceutical secondary standard
form   neat
application(s)   HPLC: suitable
  gas chromatography (GC): suitable
Featured Industry   Pharmaceutical (small molecule)
format   neat
pharmacopeia traceability   traceable to PhEur Y0000049
  traceable to USP 1029501
SMILES string   OS(=O)(=O)c1ccccc1.CCOC(=O)C2=C(COCCN)NC(C)=C(C2c3ccccc3Cl)C(=O)OC
InChI   1S/C20H25ClN2O5.C6H6O3S/c1-4-28-20(25)18-15(11-27-10-9-22)23-12(2)16(19(24)26-3)17(18)13-7-5-6-8-14(13)21;7-10(8,9)6-4-2-1-3-5-6/h5-8,17,23H,4,9-11,22H2,1-3H3;1-5H,(H,7,8,9)
InChI key   ZPBWCRDSRKPIDG-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. Amlodipine besylate is a calcium channel blocker, which inhibits the trans membrane influx of calcium ions into vascular smooth muscles and cardiac muscle. It belongs to the dihydropyridine family. It is used in combination with atorvastatin calcium to treat vasospastic angina, chronic stable angina, hypertension, in elevated serum triglyceride levels, primary dysbetalipoproteinemia.

Application

Amlodipine besylate may be used as a pharmaceutical reference standard for the quantification of the analyte in pharmaceutical formulations using different chromatography techniques and spectrophotometric technique.

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.

Biochem/physiol Actions

Amlodipine is an L-type calcium channel blocker. Amlodipine belongs to a class of cardiovascular drugs, which act at the voltage gated calcium channel of the CaV1, or L-type, class. Amlodipine also has antihypertensive and antianginal effects. Its activity resides mainly in the (-)-isomer. Amlodipine inhibits growth of human epidermoid carcinoma A431 cells and has antireproductive effects in male rats.

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 LRAC0717 in the slot below. This is an example certificate only and may not be the lot that you receive.

Safety & Documentation

Safety Information

Symbol 
GHS07  GHS07
Signal word 
Warning
Hazard statements 
Precautionary statements 
RIDADR 
NONH for all modes of transport
WGK Germany 
WGK 3
RTECS 
US7967700
Flash Point(F) 
Not applicable
Flash Point(C) 
Not applicable

Documents

Certificate of Analysis (COA)

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Protocols & Articles

Articles

HPLC Analysis of Amlodipine Enantiomers on Astec® CHIROBIOTIC® V2

From our library of Articles, Sigma-Aldrich presents HPLC Analysis of Amlodipine Enantiomers on Astec® CHIROBIOTIC® V2
Keywords: Antihypertensives, Chromatography, High performance liquid chromatography, Pharmaceutical

Peer-Reviewed Papers
15

References

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