AMLODIPINE BESYLATE

PRODUCT IDENTIFICATION

CAS NO. 88150-42-9 (Base)
111470-99-6 (Besylate)

AMLODIPINE BESYLATE

EINECS NO.  
FORMULA C26H31ClN2O8S
MOL WT. 567.05

H.S. CODE

 

TOXICITY

 
SYNONYMS Dihydropyridine calcium channel blocker Amlodipine;
(RS)-3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl- 3,5-pyridinedicarboxylate benzenesulfonate; 2-[(2-Aminoethoxy) methyl]-4-(2- Chlorophenyl)-3-Ethoxycarbonyl-5-Methoxycarbonyl- 6-Methyl-1, 4-Dihydropyridine;

CLASSIFICATION

 

PHYSICAL AND CHEMICAL PROPERTIES

PHYSICAL STATE white to off-white crystalline powder
MELTING POINT 195 - 204 C
BOILING POINT  
SPECIFIC GRAVITY  
SOLUBILITY IN WATER Slightly soluble
pH  
VAPOR DENSITY

 

AUTOIGNITION

 

NFPA RATINGS

 

REFRACTIVE INDEX

 

FLASH POINT  
STABILITY

Stable under ordinary conditions.

APPLICATIONS

Calcium ions are needed for electrical activity for the contraction of cardiac and smooth muscle and conduction of nerve cell. Calcium channel blocker is a drug which inhibits the entry of excess calcium into cells and/or prevents form the mobilization of calcium from intracellular stores, resulting in relaxation of blood vessel walls and cardiac muscle for blood to flow more freely, lowering blood pressure thereby reducing oxygen demand in the heart and relieving anginal pain. It is used in the treatment of angina, cardiac arrhythmias, and hypertension.

Some major calcium channel blockers upon chemical structure are:

  • Dihydropyridine calcium channel blockers ; Amlodipine, Lacidipine, Lercanidipine, Nicardipine, Nifedipine, Nisoldipine, Nitrendipine, Nimodipine.
  • Phenylalkylamine calcium channel blockers ; Gallopamil, Verapamil
  • Benzothiazepine calcium channel blockers Diltiazem
  • Diarylaminopropylamine ethers: Bepridil, Mibefradil

 

Amlodipine besylate is used in the treatment of hypertension and chronic stable and vasospastic angina. It a white crystalline powder; slightly soluble in water, propanol; freely soluble in methanol; sparingly soluble in ethanol; melting range 195 - 204 C; administered orally. The chemical designation is (RS) 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)- 1,4-dihydro-6-methyl-3,5- pyridinedicarboxylate benzenesulphonate.
SALES SPECIFICATION

APPEARANCE

white to off-white crystalline powder

IDENTIFICATION

Complies Test A,B

ASSAY (HPLC)

98.0 - 101.0%

IMPURITY

1.0% max
(Individual impurity: 0.2% max)

WATER

0.5% max

CLARITY IN METHANOL

Complies

SULFATED ASH

0.2% max

HEAVY METALS

20ppm max

MELTING POINT

195 - 204 C

TRANSPORTATION
PACKING
 
HAZARD CLASS  
UN NO.  
OTHER INFORMATION
Hazard Symbols: XN, Risk Phrases: 20/21/22, Safety Phrases: 36
PRICE INFORMATION
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