PHR1185

Amlodipine besylate

Pharmaceutical Secondary Standard; Certified Reference Material

• Synonym(s): (4R, S)-3-Ethyl-5-methyl 2-(2-amino-ethoxy-methyl)-4-(2-chlorophenyl)-1,4-dihydroxy-6-methyl pyridine-3,5-dicarboxylate monobenzene sulphonate, 2-[(2-Aminoethoxy)-methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5- pyridinedicarboxylic acid 3-ethyl 5-methyl ester benzene sulfonate, Norvasc
• Empirical Formula (Hill Notation): C₂₀H₂₅ClN₂O₅ · C₆H₅SO₃H
• CAS Number: 111470-99-6
• Molecular Weight: 567.05
• MDL number: MFCD00887594
• UNSPSC Code: 41116107
• PubChem Substance ID: 329823196
• NACRES: NA.24

Properties

• grade: certified reference material; pharmaceutical secondary standard
• Quality Level: 300
• Agency: traceable to Ph. Eur. Y0000049; traceable to USP 1029501
• API family: amlodipine
• CofA: current certificate can be downloaded
• technique(s): HPLC: suitable; gas chromatography (GC): suitable
• application(s): pharmaceutical (small molecule)
• format: neat
• storage temp.: 2-8°C
• 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 Ca_V1, 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.

Recommended products

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Safety Information

• Pictograms: GHS07
• Signal Word: Warning
• Hazard Statements: H302
• Precautionary Statements: P264 - P270 - P301 + P312 - P501
• Hazard Classifications: Acute Tox. 4 Oral
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 3