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Api Montelukast Sodium Powder

Name: Api Montelukast Sodium Powder
Brand: NR LIFE CARE
Price: 31000 INR
Availability: InStock

Price 31000 INR/ Kilograms

Get a Price/Quote

MOQ : 5 Kilograms

Api Montelukast Sodium Powder Specification

Ph Level
6.57.5 (in water)

Molecular Formula
C35H35ClNNaO3S

Shelf Life
24 months Months

HS Code
29420090

Structural Formula
Available on request

Solubility
Slightly soluble in water; freely soluble in methanol, ethanol and DMF

Color
White to off-white

Heavy Metal (%)
<0.001%

Melting Point
>110C (decomposes)

Particle Size
90% passing through 60 mesh

Smell
Odorless

Storage
Store in a cool, dry place below 25C; protect from light and moisture

Loss on Drying
<0.5%

Poisonous
Non poisonous as per pharmaceutical standards

Molecular Weight
608.17 g/mol GSM (gm/2)

Medicine Name
Montelukast Sodium

Chemical Name
Montelukast Sodium

CAS No
151767-02-1

Type
API (Active Pharmaceutical Ingredient)

Grade
Pharmaceutical Grade

Usage
Used in treatment of asthma, allergies, and related respiratory disorders

Purity(%)
>= 99%

Appearance
White to off-white powder

Physical Form
Powder

Bulk Density
0.30.5 g/cm

Microbial Limits
Total aerobic microbial count NMT 100 cfu/g; total yeast & mold NMT 10 cfu/g

Optical Rotation
+73 to +77 (C=1 in methanol)

Stability
Stable under recommended storage conditions

Packing
HDPE drums with double polyethylene bags, 1kg, 5kg, 10kg, or as required

Residue on Ignition
0.1%

Endotoxins
<5 EU/g

Identification
Complies with IR spectroscopy and HPLC retention time of standard

Related Substances
NMT 0.1% (any individual impurity)

Api Montelukast Sodium Powder Trade Information

Minimum Order Quantity
5 Kilograms

FOB Port
NHAVA SHEVA MUMBAI

Payment Terms
Cash Advance (CA), Cash in Advance (CID)

Supply Ability
2000 Kilograms Per Month

Delivery Time
4 Days

Sample Policy
If order is confirmed we will reimburse the sample cost

Packaging Details
DRUM

Main Export Market(s)
Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa

Main Domestic Market
All India

Certifications
ALL

About Api Montelukast Sodium Powder

Montelukast is used to prevent the symptoms of asthma. Its usually prescribed when asthma is mild and can stop it from getting worse.

Specification

Packaging Size	Drum pack
Composition	Montelukast
Treatment	Montelukast is used to prevent the symptoms of asthma. It's usually prescribed when asthma is mild a
Prescription/Non prescription	Prescription
Brand	NR
Shelf life	6 months
Country of Origin	Made in India

Superior Pharmaceutical Grade Quality

Montelukast Sodium Powder is manufactured to the highest pharmaceutical standards, ensuring purity of at least 99% and minimal impurities. With extensive analytical testing-including IR and HPLC for identification-you can trust in the consistency and reliability of this API for formulation in respiratory therapies.

Flexible Packaging and Stable Storage

Available in secure HDPE drums with double polyethylene bags, this powder is packaged in sizes ranging from 1kg to 10kg, with custom options upon request. The product retains stability for up to 24 months when stored below 25C, protected from light and moisture, making it ideal for bulk storage and ongoing supply requirements.

Designed for Safety and Efficacy

Montelukast Sodium Powder meets rigorous safety parameters, including low levels of residual solvents, microbial counts, and heavy metals. Its non-poisonous, odorless nature and pharmaceutical-grade specifications make it a reliable choice for manufacturers committed to producing safe, effective asthma and allergy medications.

FAQ's of Api Montelukast Sodium Powder:

Q: How is Montelukast Sodium Powder identified for pharmaceutical use?

A: Montelukast Sodium Powder is identified through IR spectroscopy and confirmed by the HPLC retention time, ensuring it matches the pharmaceutical standard and meets regulatory requirements.

Q: What benefits does the high purity of Montelukast Sodium Powder provide in drug formulation?

A: A purity of at least 99% ensures enhanced safety, effectiveness, and batch consistency for finished medications, while tight control over impurities provides regulatory compliance and reduced risk of side effects.

Q: When should Montelukast Sodium Powder be stored and used after procurement?

A: For optimal stability and efficacy, store the powder in a cool, dry place below 25C, protected from light and moisture. It maintains its quality for up to 24 months from the date of manufacture if recommended conditions are followed.

Q: Where can Montelukast Sodium Powder be sourced in India?

A: This API is available from leading Indian manufacturers, distributors, exporters, and suppliers, providing flexible packing options such as 1kg, 5kg, or 10kg HDPE drums to meet diverse bulk requirements.

Q: What is the recommended process for handling and storing this powder?

A: Upon receipt, verify packing integrity and transfer the powder directly to clean, dry storage facilities. Always keep it sealed in its original HDPE drum with double polyethylene bags, protected from light and moisture, to preserve chemical stability.

Q: How is Montelukast Sodium Powder typically used in pharmaceutical applications?

A: It serves as the principal API in formulations for treating asthma, allergies, and respiratory disorders, owing to its targeted leukotriene receptor blocking activity. The powder is integrated into oral dosage forms and therapies after thorough quality control testing.

Q: What are the safety benefits of this API compared to non-pharmaceutical grade alternatives?

A: Montelukast Sodium Powder is non-poisonous and follows stringent limits for microbial load, heavy metals, and endotoxins, minimizing risks and ensuring suitability for human pharmaceutical applications.