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MONTELUKAST SOD. IP

Name: MONTELUKAST SOD. IP
Brand: IPSUM LIFESCIENCES LLP
Price: 1800 INR
Availability: InStock

Price 1800 INR/ Kilograms

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MOQ : 25 Kilograms

MONTELUKAST SOD. IP Specification

Place of Origin
India

Loss on Drying
Not more than 0.5%

Moisture (%)
Not more than 0.5%

EINECS No
None allocated

Particle Size
90% below 10 microns

Molecular Formula
C35H35ClNNaO3S

Molecular Weight
608.18 g/mol

Residue on Ignition
Not more than 0.2%

Heavy Metal (%)
Not more than 10 ppm

Melting Point
>170C (decomposes)

Storage
Store in cool, dry, well-ventilated area in tightly closed container

Ph Level
6.5 8.5 (1% solution in water)

HS Code
29350090

Assay
>=99.0% (on dry basis)

Boiling point
Not applicable (decomposes before boiling)

Other Names
Montelukast Sodium, Montelukast Sodium IP

CAS No
151767-02-1

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade (IP)

Usage
Used in treatment of asthma, allergic rhinitis, and related respiratory conditions

Purity
Not less than 99% (by HPLC)

Appearance
White to off-white powder

Application
Pharmaceuticals (anti-asthmatic, anti-allergic)

Raw Material
Montelukast Sodium

Smell
Odorless

Color
White to off-white

Form
Powder

Specific Rotation
+4.0° to +5.5°

Identification
IR or HPLC complies with standard

Shelf Life
36 months from date of manufacture

Impurities
Total impurities less than 1.0% (by HPLC)

Packaging
HDPE drums with double polyethylene liners, 1 kg, 5 kg, 10 kg packs

Endotoxin Level
NMT 0.5 EU/mg

Solubility
Freely soluble in water and methanol, practically insoluble in acetonitrile

About MONTELUKAST SOD. IP

Montelukast Sodium, as defined by the Indian Pharmacopoeia (IP), is a pharmaceutical compound categorized as a leukotriene receptor antagonist. It is primarily prescribed for the treatment of asthma and allergic rhinitis, conditions where it helps alleviate symptoms by blocking the action of leukotrienes, which are inflammatory molecules in the body.

Exceptional Purity and Compliance

Montelukast Sodium IP meets rigorous specifications, including a purity of no less than 99% via HPLC analysis, total impurities under 1%, and a shelf life of 36 months. It is identified by IR or HPLC in compliance with standards, reassuring users of its reliability in critical pharmaceutical applications.

Versatile Pharmaceutical Applications

With proven efficacy in treating asthma and allergic rhinitis, Montelukast Sodium IP serves as a vital ingredient for a range of anti-asthmatic and anti-allergic formulations. Its pharmaceutical grade and high assay make it an optimal choice for medical manufacturers seeking consistent quality.

Safe and Easy Storage Solutions

Packaged in HDPE drums with double polyethylene liners in sizes of 1 kg, 5 kg, and 10 kg, Montelukast Sodium IP ensures safety and longevity. It should be stored in cool, dry, well-ventilated conditions to maintain its stability throughout the shelf life.

FAQ's of MONTELUKAST SOD. IP:

Q: How should Montelukast Sodium IP be stored to maintain its quality?

A: Montelukast Sodium IP should be kept in a cool, dry, and well-ventilated space within tightly closed HDPE containers with double polyethylene liners. Proper storage helps preserve its shelf life of 36 months and protects against moisture and contamination.

Q: What pharmaceutical applications is Montelukast Sodium IP suited for?

A: Montelukast Sodium IP is primarily used in the manufacture of medications treating asthma, allergic rhinitis, and related respiratory conditions. Its high purity and efficacy make it ideal for anti-asthmatic and anti-allergic pharmaceutical formulations.

Q: When does Montelukast Sodium IP expire?

A: Montelukast Sodium IP has a shelf life of 36 months from the date of manufacture, provided it is properly stored in its recommended conditions.

Q: Where is Montelukast Sodium IP manufactured?

A: Montelukast Sodium IP is manufactured, supplied, and traded in India, ensuring strict compliance with international pharmaceutical standards.

Q: What quality tests does Montelukast Sodium IP undergo before supply?

A: Montelukast Sodium IP is tested for assay (99%), impurities (less than 1.0% by HPLC), endotoxin level (0.5 EU/mg), moisture, residue on ignition, heavy metals, and identification by IR or HPLC before distribution to guarantee safety and quality.

Q: How is Montelukast Sodium IP packaged for transport and storage?

A: This API is packed in high-density polyethylene drums lined with double polyethylene liners, available in 1 kg, 5 kg, and 10 kg packs to ensure secure and contamination-free storage and transportation.

Q: What are the primary benefits of using Montelukast Sodium IP in formulations?

A: Montelukast Sodium IP offers high purity, stable properties, ease of formulation due to its solubility, and proven clinical benefits for respiratory conditions, making it a trusted ingredient for pharmaceutical manufacturers.

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