AMLODIPINE BESYLATE

AMLODIPINE BESYLATE
PRODUCT IDENTIFICATION
CAS NO.	88150-42-9 (Base) 111470-99-6 (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