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Montelukast Sodium Api Powder

Price 35500.0 INR/ Piece

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MOQ : 20 Pieces

Montelukast Sodium Api Powder Specification

Melting Point
110-115C

Solubility
Practically insoluble in water, freely soluble in ethanol and methanol

Particle Size
D90 < 20 microns

Structural Formula
Available on request

Taste
Not determined

Heavy Metal (%)
Not more than 0.001%

HS Code
29420090

Loss on Drying
Not more than 0.5%

Smell
Odorless

Molecular Formula
C35H35ClNNaO3S

Boiling point
Not applicable (decomposes)

Molecular Weight
608.17 g/mol

Color
White to off-white

EINECS No
None assigned

Poisonous
Non-poisonous

Ph Level
7.0 - 9.0 (1% solution)

Shelf Life
2 years

Storage
Store below 25C in a tightly closed container, protected from light and moisture

Medicine Name
Montelukast Sodium Api Powder

Chemical Name
Montelukast Sodium

CAS No
151767-02-1

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used as an anti-asthmatic and anti-allergic agent

Purity(%)
99%

Appearance
White to off-white powder

Physical Form
Powder

Identification
By IR and HPLC

Stability
Stable under recommended storage conditions

Related Substances
Total impurities not more than 1.0%

Residual Solvents
Complies with ICH guidelines

Packaging
Double LDPE bags inside HDPE drums

Microbial Limit
Total aerobic microbial count NMT 1000 cfu/g; Total yeast and mold count NMT 100 cfu/g; E. coli and Salmonella absent

Optical Rotation
Not more than -3.0°

Assay
98.0% - 102.0% (on dried basis)

Montelukast Sodium Api Powder Trade Information

Minimum Order Quantity
20 Pieces

Supply Ability
100 Pieces Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Montelukast Sodium Api Powder

Grade Standard	USP
Grade	Pharma Grade
Packaging	25Kg Bag
CAS Number	158966-92-8
Purity	>99%
Usage/Application	Pharmaceutical
Molecular Weight	586.2 g/mol
Chemical Formula	C35H36ClNO3S
Minimum Order Quantity	25 Kg

Product Specification

Grade Standard	IP
Grade	Pharma Grade
Packaging	25Kg Drum
Purity	90%-95%
Usage/Application	Pharmaceutical

Product DescriptionGrade -ip/bp/uspi i i i
make-i morepen , medicarei
ready stocki
All documents will be providedi

High Purity and Stringent Quality Control

Montelukast Sodium API Powder offers unmatched quality, boasting 98.0% to 102.0% assay and a total impurity threshold of less than 1.0%. Manufactured with a strict focus on safety, it aligns with ICH guidelines for residual solvents, possesses extremely low heavy metal content (0.001%), and maintains compliance with rigorous microbial limits. Each batch is rigorously tested by IR and HPLC to ensure consistent identity and purity.

Secure Packaging and Stable Storage

Delivered in double-layer LDPE bags housed within HDPE drums, Montelukast Sodium API Powder is protected from moisture and light. Best stored below 25C in tightly closed containers, it remains stable for up to two years. This robust packaging preserves the powder's pharmaceutical-grade integrity throughout shipping and storage, making it an ideal choice for global importers, exporters, manufacturers, and suppliers.

Pharmaceutical Versatility and Usage

The API's excellent physical and chemical characteristics-such as D90 < 20 microns particle size and pH 7.0-9.0 (1% solution)-facilitate its use across diverse anti-asthmatic and anti-allergic formulations. Its high solubility in ethanol and methanol ensures efficient formulation processes, while its certified purity supports reliable and effective therapeutics in the pharmaceutical market.

FAQ's of Montelukast Sodium Api Powder:

Q: How is Montelukast Sodium API Powder identified and tested for quality?

A: Montelukast Sodium API Powder is identified using Infrared Spectroscopy (IR) and High Performance Liquid Chromatography (HPLC). Each batch undergoes rigorous quality testing, including assay (98.0%-102.0%), impurity profiling, residual solvent analysis (as per ICH guidelines), and strict microbial limit testing to ensure its pharmaceutical-grade quality.

Q: What are the main benefits of using Montelukast Sodium API Powder?

A: Montelukast Sodium API Powder offers high purity (99%), stringent impurity control, stability, and compliance with international standards. Its excellent safety profile and pharmaceutical grade make it ideal for the manufacture of anti-asthmatic and anti-allergic medications that require reliable and consistent performance.

Q: When should Montelukast Sodium API Powder be used in the manufacturing process?

A: This API should be incorporated during the active ingredient phase of pharmaceutical formulation, where high purity and consistent physical properties are crucial. Formulators typically use it for oral dosage forms, taking advantage of its stability and solubility profile to ensure dosage accuracy and therapeutic effectiveness.

Q: Where is Montelukast Sodium API Powder produced and what packaging ensures its quality?

A: This product is manufactured in India and supplied globally. It is packaged securely in double-layer LDPE bags placed inside HDPE drums, protecting the powder from light and moisture, and maintaining its stability during transit and storage.

Q: What are the recommended storage conditions and shelf life for Montelukast Sodium API Powder?

A: It is advised to store the powder below 25C in a tightly closed container, protected from light and moisture. Under these recommended conditions, the shelf life of Montelukast Sodium API Powder is up to two years.

Q: How is the microbial safety of Montelukast Sodium API Powder maintained?

A: The powder adheres to strict microbial limits: total aerobic count less than 1000 cfu/g, yeast and molds below 100 cfu/g, and absence of harmful bacteria such as E. coli and Salmonella. These standards are regularly tested to ensure microbiological safety for pharmaceutical applications.

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