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S-AMLODIPINE MALELATE IP/BP/EP/USP

Name: S-AMLODIPINE MALELATE IP/BP/EP/USP
Brand: IPSUM LIFESCIENCES LLP
Price: 1800 INR
Availability: InStock

Price 1800 INR/ Kilograms

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MOQ : 25 Kilograms

S-AMLODIPINE MALELATE IP/BP/EP/USP Specification

Moisture (%)
0.5%

Molecular Weight
524.95 g/mol

Assay
99.0% (HPLC)

HS Code
29420090

Particle Size
Not less than 90% passes through 60 mesh

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

Melting Point
163168C

Molecular Formula
C20H25ClN2O5C4H4O4

Heavy Metal (%)
0.001%

Place of Origin
India

Loss on Drying
0.5%

Residue on Ignition
0.1%

Other Names
S-Amlodipine Malate; S-Amlodipine Maleate; (S)-Amlodipine Maleate

CAS No
880725-36-8

Type
Pharmaceutical Raw Material

Grade
Pharmaceutical Grade

Usage
Anti-hypertensive

Purity
99% Min

Appearance
White to off-white powder

Application
Formulation of anti-hypertensive drugs

Raw Material
Yes

Smell
Odorless

Color
White to off-white

Form
Powder

Packaging
HDPE drum with double polyethylene bags; 1 kg, 5 kg, 10 kg

Optical Activity
[]25/D +10 to +14 (c=1, MeOH)

Shelf Life
2 years when properly stored

Identification
By IR, HPLC conforming to standard

Genotoxic Impurities
Complies with specifications

Solubility
Freely soluble in methanol, sparingly soluble in water

Storage Temperature
28C

USP/EP/BP/CP Compliance
Meets all respective pharmacopeia specifications

Related Substances
Total impurities 0.5%

Bacterial Endotoxins
< 0.25 EU/mg

About S-AMLODIPINE MALELATE IP/BP/EP/USP

It seems there was a typographical error in your request. The correct term is "amlodipine besylate," not "amlodipine malelate." Amlodipine besylate is the commonly used form of amlodipine, and here is a brief description according to various pharmacopeias:

Comprehensive Quality Assurance

S-Amlodipine Maleate is manufactured and tested according to stringent international pharmacopeia standards (IP/BP/EP/USP/CP), ensuring high quality and consistent performance in drug formulations. Analytical identity is confirmed by IR and HPLC, while purity is confirmed by assay value and control of related and genotoxic impurities. Multiple safety and quality markers, including bacterial endotoxins and heavy metals, are kept meticulously low.

Optimal Packaging and Stability

This raw material is provided in robust HDPE drums lined with double polyethylene bags, available in 1 kg, 5 kg, and 10 kg packs. With a shelf life of 2 years under recommended storage conditions (2-8C, protected from light), the product maintains its integrity and purity, crucial for reliable pharmaceuticals manufacturing.

FAQ's of S-AMLODIPINE MALELATE IP/BP/EP/USP:

Q: How should S-Amlodipine Maleate be properly stored to maintain its quality?

A: S-Amlodipine Maleate should be stored in a cool, dry place at a temperature between 2 and 8C, protected from light and moisture. It must remain in its original packaging, preferably HDPE drums with double polyethylene bags, to maintain its chemical stability and prevent contamination.

Q: What are the main uses of S-Amlodipine Maleate?

A: S-Amlodipine Maleate is primarily used in the pharmaceutical industry as a raw material for formulating anti-hypertensive drugs, contributing to the effective management of high blood pressure in patients.

Q: Where is S-Amlodipine Maleate typically sourced and manufactured?

A: This pharmaceutical-grade raw material is sourced and manufactured in India by qualified manufacturers, suppliers, and traders, adhering to international quality benchmarks and pharmacopeia specifications.

Q: When does S-Amlodipine Maleate expire and how long is its shelf life?

A: S-Amlodipine Maleate has a shelf life of 2 years when stored under recommended conditions. Proper storage is essential to preserve potency and prevent degradation.

Q: How is the quality and identity of S-Amlodipine Maleate verified?

A: The identity and purity are routinely confirmed using IR and HPLC techniques, with additional testing ensuring compliance regarding impurities, bacterial endotoxins, heavy metals, and genotoxic impurities-delivering pharmaceutical-grade quality.

Q: What is the process for using S-Amlodipine Maleate in formulations?

A: S-Amlodipine Maleate is supplied as a finely milled powder (over 90% passing 60 mesh), making it readily applicable for blending into pharmaceutical formulations during tablet or capsule manufacturing as directed by validated procedures.

Q: What benefits does S-Amlodipine Maleate offer to pharmaceutical manufacturers?

A: Offering high purity (99.0%), low impurity levels, reliable solubility, and compliance with major international standards, S-Amlodipine Maleate ensures consistent drug formulation and patient safety, supporting trusted hypertension product development.

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