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Amlodipine Besylate [BP/EP]

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MOQ : 50 Kilograms

Amlodipine Besylate [BP/EP] Specification

Grade
BP/EP

Physical Form
Powder

Ingredients
Amlodipine Besylate

Smell
Odorless

Shelf Life
5 years if properly stored

Structural Formula
Available upon request

Molecular Formula
C20H25ClN2O5C6H6O3S

Product Type
Active Pharmaceutical Ingredient

HS Code
29420090

Purity
>=99%

Shape
Crystalline

Molecular Weight
567.1 g/mol

Solubility
Soluble in water, methanol, and ethanol

Application
Pharmaceuticals

Taste
Characteristic

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

Amlodipine Besylate [BP/EP] Trade Information

Minimum Order Quantity
50 Kilograms

Supply Ability
1 Kilograms Per Week

Delivery Time
1 Week

About Amlodipine Besylate [BP/EP]

Amlodipine Besylate

Synonyms of Amlodipine Besylate : Amlodipine; amlodipine besylate; Norvasc; (RS)-3-ethyl-5-methyl-2-(2- aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate;

Formula : C₂₆H₃₁ClN₂O₈S

CAS RN : 88150-42-9 ; 111470-99-6

Uses of Amlodipine Besylate : Antianginal , Antihypertensive.

Specification : As per BP/EP

Impurity Profile of Amlodipine Besylate :
By HPLC

Impurity D : -ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate.	0.3 %
Total of other impurities	0.3%

By TLC

Any impurities.

In the chromatogram obtained with reference solution (a):- Any impurity : any spot ,apart from the principal spot, is not more intense than the spot in the chromatogram obtained with reference solution (c) (0,3%) and at most 2 spots are more intense than the spot in the chromatogram obtained with reference solution (d) (0.1%)

Premium Quality and Compliance

Our Amlodipine Besylate meets the British and European Pharmacopoeia requirements with impurity levels, residual solvents, loss on drying, and heavy metals all within regulatory limits. The products superior purity and crystalline form ensure consistent quality for pharmaceutical manufacturing.

Versatile Applications

Amlodipine Besylate is commonly used as a key ingredient in pharmaceutical formulations targeting cardiovascular conditions. Its high solubility in water, methanol, and ethanol allows for flexible incorporation into a range of drug delivery systems and formulations, supporting diverse industry needs.

Safe and Secure Packaging

Packaged in HDPE drums with double polythene liners, Amlodipine Besylate remains stable throughout storage and transportation. This robust packaging safeguards the product from moisture, contamination, and light exposure, thus preserving its quality and extending shelf life up to 5 years.

FAQs of Amlodipine Besylate [BP/EP]:

Q: How should Amlodipine Besylate [BP/EP] be stored to maintain its stability?

A: Amlodipine Besylate should be stored in a cool, dry place, protected from light, and kept in its original HDPE drum with double polythene liners to ensure maximum stability throughout its 5-year shelf life.

Q: What quality standards does Amlodipine Besylate [BP/EP] comply with?

A: This product complies with BP/EP standards for impurity level, loss on drying, and heavy metals. It also meets ICH guidelines for residual solvents, ensuring high pharmaceutical-grade purity.

Q: When can structural formula details for Amlodipine Besylate [BP/EP] be obtained?

A: Structural formula information is available upon request. Please contact us directly to receive detailed documentation or specifications.

Q: Where is Amlodipine Besylate [BP/EP] manufactured and supplied from?

A: Amlodipine Besylate [BP/EP] is manufactured and supplied from India. We serve as a distributor, exporter, importer, manufacturer, retailer, supplier, trader, and wholesaler, catering to both local and global markets.

Q: What is the recommended process for handling and packaging this product?

A: The product is packaged in HDPE drums with double polythene liners to prevent contamination and moisture ingress. Handle using appropriate safety practices and keep the package sealed when not in use for optimal shelf life.

Q: How is Amlodipine Besylate [BP/EP] used in pharmaceutical applications?

A: Amlodipine Besylate [BP/EP] is incorporated as an active pharmaceutical ingredient in formulations for cardiovascular medications, owing to its high purity, solubility, and compliance with stringent quality standards.

Q: What benefits does this product offer to pharmaceutical manufacturers?

A: Pharmaceutical companies benefit from its high purity (99%), customizable particle size, reliable packaging, and consistent compliance with international quality standards, ensuring effective integration into diverse medicinal products.

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