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Antifungal Itraconazole Api Powder

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Antifungal Itraconazole Api Powder Specification

Melting Point
166-170C

Poisonous
Non-poisonous as API

Taste
Bitter

HS Code
29420090

EINECS No
617-859-2

Loss on Drying
0.5%

Heavy Metal (%)
<0.001%

Molecular Weight
705.64 g/mol Grams (g)

Solubility
Practically insoluble in water, freely soluble in dichloromethane

Color
White to off-white

Shelf Life
5 Years

Storage
Store below 25C, protect from light and moisture

Molecular Formula
C35H38Cl2N8O4

Smell
Odorless

Structural Formula
(Displayed in image)

Medicine Name
Itraconazole API Powder

Chemical Name
Itraconazole

CAS No
84625-61-6

Type
Antifungal API

Grade
Pharmaceutical Grade

Usage
Used in formulation of antifungal medicines

Purity(%)
>99%

Appearance
White to slightly yellow crystalline powder

Physical Form
Powder

Transport Conditions
Keep container tightly closed and dry

Impurities
Within ICH limits

Packing Size
1 kg, 5 kg, 25 kg

Microbial Limit
Complies with pharmacopeial standards

Related Substances
Max 0.5%

Identification
By IR and HPLC for confirmation

Residue on Ignition
0.1%

Packaging
HDPE drum with double polybag liner

Antifungal Itraconazole Api Powder Trade Information

Supply Ability
1000 Per Day

Delivery Time
7 Days

Sample Available
No

Main Domestic Market
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About Antifungal Itraconazole Api Powder

Itraconazole capsule is usedto treat fungal infections, such as aspergillosis (fungal infection in the lungs), blastomycosis (Gilchrists disease), or histoplasmosis (Darlings disease).

Quality Assurance and Identification

Each batch of Itraconazole API Powder undergoes comprehensive testing including IR and HPLC for identity verification. With a purity exceeding 99% and related substances maintained below 0.5%, the product complies with global ICH guidelines, ensuring pharmaceutical-grade quality for antifungal drug formulation.

Packaging and Transport

Itraconazole API Powder is securely packaged in HDPE drums lined with double polybags to ensure product integrity. Available in 1 kg, 5 kg, and 25 kg sizes, it must be kept tightly closed and stored in a dry place below 25C, protected from light and moisture, maintaining product stability during transport and storage.

Usage and Benefits

Itraconazole API Powder serves as the core ingredient in antifungal medicine manufacturing. Its superior purity, low impurity levels, and compliance with pharmacopeial standards make it ideal for developing safe and effective treatments for fungal infections, contributing to improved patient outcomes.

FAQs of Itraconazole Api Powder:

Q: How is the identity of Itraconazole API Powder confirmed?

A: The identity of Itraconazole API Powder is verified using both Infrared Spectroscopy (IR) and High-Performance Liquid Chromatography (HPLC) for robust confirmation of the compound.

Q: What is the recommended process for storing and transporting Itraconazole API Powder?

A: It should be kept tightly sealed in HDPE drum packaging with double polybag liner, stored below 25C, and protected from moisture and light to preserve its quality during transport and storage.

Q: When can Itraconazole API Powder be used in pharmaceutical formulations?

A: Itraconazole API Powder can be utilized in the manufacturing process whenever a potent and pure antifungal active ingredient is required, ensuring compliance with pharmacopeial standards.

Q: Where is Itraconazole API Powder manufactured and supplied from?

A: This API powder is exported, imported, manufactured, and supplied from India, meeting international quality and regulatory requirements.

Q: What are the microbial and impurity specifications of Itraconazole API Powder?

A: The product complies with pharmacopeial limits for microbial contamination and impurities, with impurity levels maintained within ICH guidelines and related substances not exceeding 0.5%.

Q: How should Itraconazole API Powder be used in antifungal medicine production?

A: Pharmaceutical manufacturers incorporate the powder as the active ingredient in formulations designed to treat various fungal infections, leveraging its high purity and efficacy.

Q: What benefits does Itraconazole API Powder offer to pharmaceutical companies?

A: Its high purity, comprehensive quality documentation, long shelf life (5 years), and rigorous compliance standards facilitate consistent, effective, and safe production of antifungal medications.

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