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LEVA AMLODIPINE BESILATE ( S-Amlodpine Besilate ) API

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LEVA AMLODIPINE BESILATE ( S-Amlodpine Besilate ) API

Price 10500.0 INR/ Kilograms

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MOQ : 20 Kilograms

LEVA AMLODIPINE BESILATE ( S-Amlodpine Besilate ) API Specification

Smell
Odorless

Melting Point
174-179C

Storage
Store in a cool, dry place below 30C, protected from light

Color
White to off-white

Loss on Drying
Not more than 0.5%

Ph Level
6.5-7.5

HS Code
29420090

Molecular Weight
567.1 g/mol

Structural Formula
Available upon request

Molecular Formula
C20H25ClN2O5C6H6O3S

Poisonous
Non-poisonous as API

Particle Size
D90 < 50 microns

Shelf Life
36 months

Solubility
Freely soluble in methanol, practically insoluble in water

Taste
Tasteless

Heavy Metal (%)
Not more than 0.001%

Medicine Name
LEVA AMLODIPINE BESILATE

Chemical Name
S-Amlodipine Besilate

CAS No
126881-98-3

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharma Grade

Usage
Used for the treatment of hypertension and angina

Purity(%)
Not less than 99.0%

Appearance
White to off-white powder

Physical Form
Solid

Residual Solvents
Complies with pharmacopeia standards

Packing Details
Packed in double LDPE bags inside HDPE/Drum

Related Substances
Total impurities not more than 0.5%

Microbial Limit
Complies with EP/IP/USP standards

Stability
Stable under recommended storage conditions

Specific Optical Rotation
+7° to +13°

Transportation
Non-hazardous according to ADR/RID/IMDG/IATA

Labeling
Properly labeled as per applicable regulations

Moisture Content
<0.2%

Stereochemistry
S-Enantiomer (Single enantiomer for enhanced activity)

Polymorphism
Single crystalline form

Assay (HPLC)
Not less than 99%

LEVA AMLODIPINE BESILATE ( S-Amlodpine Besilate ) 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 LEVA AMLODIPINE BESILATE ( S-Amlodpine Besilate ) API

Molar Mass	408.879g/mol
Molecular Formula	408.879g/mol
Boiling Point	STANDARD
GRADE	IP/BP/USP
COUNTRIE ORIGINE	INDIA
Minimum Order Quantity	25 Kg

Product Specification

Molar Mass	408.879g/mol
Molecular Formula	408.879g/mol
Boiling Point	STANDARD
Minimum Order Quantity	25 Kg

Product Description
Product DescriptionWe are manufacturer and exporter ofiAmlodipine Besylate API.
Amlodipine Besylate APIiis used with or without other medications to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.iAmlodipinebelongs to a class of drugs known as calcium channel blockers. It works by relaxing blood vessels so blood can flow more easily.

Superior Stereochemistry for Potent Activity

LEVA AMLODIPINE BESILATE contains the S-enantiomer, which is the superior, active form of amlodipine. This single enantiomer enhances therapeutic effects and reduces potential side effects, making it an excellent choice for hypertension and angina treatment. Its purity and specificity provide consistent and reliable results in pharmaceutical formulations.

Strict Compliance and Safety Standards

Manufactured under rigorous standards, this API meets stringent EP, IP, and USP guidelines, ensuring high quality, reliability, and safety. It is classified as non-hazardous for transportation and is free of notable heavy metals and toxic impurities. Residual solvents and microbial loads are well within pharmacopeial limits, making it safe for manufacturing and distribution.

Optimal Packaging and Storage for Longevity

The API is packed in double LDPE bags within HDPE drums to protect from contamination and moisture. Clear, regulatory-compliant labeling supports traceability. With recommended storage below 30C and protection from light and humidity, the product remains stable for up to three years, offering peace of mind to manufacturers and suppliers.

FAQ's of LEVA AMLODIPINE BESILATE ( S-Amlodpine Besilate ) API:

Q: How should LEVA AMLODIPINE BESILATE (S-Amlodipine Besilate) API be stored for optimal stability?

A: To maintain optimal stability, store the API in a cool, dry place below 30C, protected from light and humidity. This ensures a shelf life of up to 36 months without compromising purity or efficacy.

Q: What are the benefits of using the S-enantiomer form of amlodipine in pharmaceutical formulations?

A: The S-enantiomer form provides enhanced activity for hypertension and angina treatment, with improved therapeutic outcomes and reduced side effects compared to racemic mixtures. Its single enantiomer composition ensures higher specificity and efficacy.

Q: When is LEVA AMLODIPINE BESILATE most commonly used?

A: LEVA AMLODIPINE BESILATE is primarily used during the manufacturing of pharmaceutical products intended for the treatment of hypertension and angina, due to its proven efficacy as a calcium channel blocker.

Q: Where is the product manufactured and can it be exported internationally?

A: This API is manufactured in India under strict pharmaceutical standards and is available for export and import globally. Proper packaging and documentation ensure compliance with international regulatory and safety requirements.

Q: What processes ensure the quality and purity of this API?

A: Stringent quality checks, including HPLC assay (purity not less than 99.0%), monitoring for total impurities (below 0.5%), and compliance with pharmacopeia standards for residual solvents and microbial limits, are followed to guarantee high product quality.

Q: How is the product packaged for safe transportation and storage?

A: LEVA AMLODIPINE BESILATE is packed in double LDPE bags inside HDPE drums, ensuring protection from contamination and moisture. Each container is clearly labeled according to applicable regulations.

Q: Why is this API considered non-hazardous for transport?

A: The product meets the criteria set forth by ADR/RID/IMDG/IATA for non-hazardous substances, making it safe to handle and transport through standard shipping channels worldwide.

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