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Amlodipine Besylate Api

Price 10500.0 INR/ Kilograms

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MOQ : 20 Kilograms

Amlodipine Besylate Api Specification

Molecular Formula
C20H25ClN2O5.C6H6O3S

Shelf Life
36 months

Boiling point
Not applicable (decomposes)

HS Code
29420090

Taste
Bitter

Structural Formula
Refer chemical structure image

Storage
Store in a cool, dry place, protected from light

Poisonous
Non-poisonous under standard conditions

Smell
Odorless

Melting Point
196-203C

Molecular Weight
567.1 g/mol

EINECS No
629-950-1

Solubility
Freely soluble in methanol; slightly soluble in water

Loss on Drying
0.5%

Color
White to off-white

Ph Level
5.0 7.0 (1% aqueous solution)

Particle Size
D90 < 10 micron

Heavy Metal (%)
0.001%

Medicine Name
Amlodipine Besylate API

Chemical Name
2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridine dicarboxylate monobenzenesulfonate

CAS No
111470-99-6

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used as an antihypertensive, calcium channel blocker, and for treatment of angina

Purity(%)
99%

Appearance
White to off-white powder

Physical Form
Solid

Assay (on dried basis)
>99.0%

Microbial Limit
Complies with pharmacopeial standards

Identification Tests
Complies with USP/Ph. Eur. standards

Packing
Double polyethylene bags in fiber drums (25 kg net)

Note
For pharmaceutical manufacturing use only, not for direct human consumption

Manufacturing Standard
GMP Certified Facility

Related Substances
Total impurities 0.3%

Specific Rotation
-1.0 to +1.0 (in methanol)

Residue on Ignition
0.1%

Amlodipine Besylate Api Trade Information

Minimum Order Quantity
20 Kilograms

Supply Ability
100 Kilograms Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Amlodipine Besylate Api

Molar Mass	567.1
Molecular Formula	C26H31ClN2O8S
Boiling Point	95
india	4300
CAS Number	88150-42-9
Grade	IP / BP / EP / USP
Minimum Order Quantity	10 Kg

Molecular formula:C20H25ClN2O5,C6H6O3S
Molecular weight:567.10
CAS Number:111470-99-6
Application:Antihypertensive
Specification:As per IP/BP/EP/USP

Amlodipine benzenesulfonate is the benzenesulfonate salt of amlodipine. It has a role as a vasodilator agent, a calcium channel blocker and an antihypertensive agent. It contains an amlodipine.
Amlodipine Besylate is the besylate salt of amlodipine,a syntheticdihydropyridine with antihypertensive and antianginal effects.Amlodipineinhibits the influx of extracellularcalciumions into myocardial and peripheral vascular smooth muscle cells, thereby preventing vascular and myocardial contraction. This results in a dilatation of the main coronary and systemic arteries, decreased myocardial contractility, increased blood flow andoxygendelivery to the myocardial tissue, and decreased total peripheral resistance. This agent may also modulate multi-drug resistance (MDR) activity through inhibition of the p-glycoprotein efflux pump.

High-Quality Manufacturing Standards

Manufactured in a GMP-certified facility, Amlodipine Besylate API meets rigorous international pharmaceutical standards. Each batch undergoes comprehensive quality control checks including strict assays, microbial limits, and impurity profiling to ensure complete compliance with both USP and Ph. Eur. requirements.

Physicochemical Properties Designed for Stability

The API features a specific rotation of -1.0 to +1.0 in methanol and exhibits a particle size distribution (D90 < 10 micron) optimal for tablet and capsule formulations. Freely soluble in methanol and with a controlled pH range of 5.07.0, it maintains stability and compatibility during pharmaceutical processing.

Packaging and Storage for Maximum Shelf Life

Supplied in robust fiber drums lined with double polyethylene bags, the product is protected during transport and storage. For best results, store Amlodipine Besylate API in a cool, dry, and light-protected environment to ensure its quality over the 36-month shelf life.

FAQs of Amlodipine Besylate Api:

Q: How should Amlodipine Besylate API be stored to guarantee stability over its shelf life?

A: Amlodipine Besylate API should be stored in a cool, dry place, away from light, in its original double polyethylene bags within fiber drums. Proper storage maintains its quality and ensures a shelf life of up to 36 months.

Q: What process ensures the compliance of Amlodipine Besylate API with pharmacopeial standards?

A: Each batch of Amlodipine Besylate API undergoes thorough quality testing for assay, impurity levels, identification, and microbial limits, in accordance with USP and Ph. Eur. standards, within a GMP-certified manufacturing facility.

Q: When is Amlodipine Besylate API typically used in pharmaceutical manufacturing?

A: Amlodipine Besylate API is utilized during the formulation and production stage of antihypertensive and antianginal medications, where its high purity and physicochemical properties contribute to the consistent performance of the final product.

Q: Where does the manufacturing and supply of this API occur?

A: Amlodipine Besylate API is manufactured, exported, and supplied from India by GMP-certified facilities that adhere to international regulatory standards for pharmaceutical ingredients.

Q: What are the main benefits of using this API in medicine production?

A: Its high purity (99%), low levels of impurities (0.3%), and excellent micro and physicochemical control provide consistent efficacy and safety in finished pharmaceutical formulations, ensuring reliability for manufacturers and healthcare providers.

Q: How does the physical form and solubility of Amlodipine Besylate API enhance its application?

A: The white to off-white powder, with a fine particle size (D90 < 10 micron) and high solubility in methanol, allows for homogeneous mixing and ease of processing during large-scale pharmaceutical manufacturing.

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