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Itraconazole Pellets

Price 24000 INR/ Kilograms

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MOQ : 100 Grams

Itraconazole Pellets Specification

Boiling point
Not Applicable (decomposes before boiling)

Other Names
Sporanox

Density
1.38 Gram per cubic centimeter(g/cm3)

Molecular Weight
705.63 g/mol

HS Code
29420090

Ph Level
Neutral

Melting Point
166-170C

Smell
Odourless

Shape
Pellet

Structural Formula
Available on request

Form
Solid

Poisonous
Yes

Molecular Formula
C35H38Cl2N8O4

Taste
Bitter

Purity
98% (By HPLC)

Storage
Keep in a cool, dry place, away from direct sunlight.

Solubility
Practically insoluble in water, soluble in dichloromethane, sparingly soluble in methanol and ethanol.

Classification
Antifungal Agent

Chemical Name
Itraconazole

CAS No
84625-61-6

EINECS No
642-356-6

Grade
Pharmaceutical Grade

Standard
USP/IP/BP

Type
Pharmaceutical Pellets

Usage
Used in oral formulations and capsule products as antifungal therapy.

Main Material
Itraconazole

Application
Antifungal; pharmaceutical use for treatment of systemic and superficial fungal infections.

Release Profile
Controlled release and immediate release available

Shelf Life
36 months from the date of manufacture

Packaging
HDPE drum with double polyethylene bags, 5-25 kg packing

Particle Size
18-60 mesh (customizable)

Disintegration Time
As per pharmacopoeia standard

Excipients
Contains sugar spheres, hypromellose, and other pharmaceutical excipients

Assay
Itraconazole content within pellet core: NLT 90% and NMT 110% of the labeled amount

Appearance
White to off-white pellets

Loss on Drying
NMT 2.0%

Moisture Content
NMT 2.0%

Itraconazole Pellets Trade Information

Minimum Order Quantity
100 Grams

Supply Ability
1 Gram Per Week

Delivery Time
1 Week

About Itraconazole Pellets

Itraconazole Pellets

Other Name : 2-butan-2-yl-4-[4-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one

CAS Number : 84625-61-6

Molecular Formula : C35H38CI2N8O4

Application : Anti Fungal. Used in the treatment of stomach upset/ indigestion and other gastrointestinal conditions

Comprehensive Antifungal Solution

Itraconazole Pellets deliver a reliable approach for pharmaceutical manufacturers targeting both systemic and superficial fungal infections. Featuring customizable particle size, controlled or immediate release, and compatibility with oral dosage forms, these pellets meet stringent international standards (USP/IP/BP) and regulatory compliance, ensuring both efficacy and safety in antifungal therapy.

Stringent Quality and Stability

Each batch of Itraconazole Pellets is thoroughly tested to ensure moisture and loss on drying do not exceed 2.0%, while assay levels are tightly regulated for consistency. The neutral pH and odorless nature make them suitable for a range of oral pharmaceutical formulations, with a solid 36-month shelf life when stored properly.

FAQs of Itraconazole Pellets:

Q: How are Itraconazole Pellets typically used in pharmaceutical formulations?

A: Itraconazole Pellets are mainly used in oral formulations, such as capsules, for the treatment of systemic and superficial fungal infections. Formulators can select either controlled or immediate release profiles depending on therapeutic requirements.

Q: What are the storage requirements for maintaining the quality of Itraconazole Pellets?

A: These pellets should be stored in a cool, dry place, away from direct sunlight, ideally in their original HDPE drums with double polyethylene bags to preserve quality and maximize their 36-month shelf life.

Q: When should Itraconazole Pellets be chosen over other antifungal agents?

A: Itraconazole Pellets are preferred when high assay accuracy, customized particle size, versatile release profiles, and proven efficacy against multiple fungal infections are required, especially in oral dosage forms.

Q: Where are these pellets generally produced and distributed?

A: Itraconazole Pellets are manufactured, distributed, and exported by numerous reputable companies across India, catering to the needs of pharmaceutical manufacturers, exporters, importers, and retailers worldwide.

Q: What is the process for ensuring the assay and purity of these pellets meet regulatory standards?

A: Every batch is tested using advanced techniques, such as HPLC, ensuring the Itraconazole content is between 90% to 110% of the labeled amount, and a purity level of at least 98%. Additional pharmacopoeial tests verify compliance with global standards.

Q: What are the benefits of using these pellets in oral antifungal therapy?

A: Itraconazole Pellets offer precise dosing, customizable release profiles, reliable stability, and compatibility with a wide array of excipients. Their neutral pH and odorless, bitter-tasting formulation facilitate integration into diverse capsule and oral tablet products.

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