Itraconazole ITR 32mcg

Itraconazole ITR 32mcg Specification

Usage
For manufacturing oral and topical antifungal formulations

Physical Form
Powder

Molecular Weight
705.64 g/mol

Poisonous
NO

Storage
Store in a cool, dry, and well-ventilated place; protect from light

CAS No
84625-61-6

Shelf Life
3 years

Properties
Antifungal agent, triazole derivative, broad spectrum

Product Type
Pharmaceutical Raw Material

Melting Point
166-170C

Density
1.36 Gram per cubic centimeter(g/cm3)

HS Code
29420090

Ingredients
Itraconazole

EINECS No
159273-13-9

Shape
Crystalline powder

Appearance
White to off-white powder

Taste
Bitter

Smell
Odorless

Solubility
Practically insoluble in water; soluble in methanol and dichloromethane

Ph Level
Neutral (6.5-7.5)

Grade
Pharmaceutical Grade

Molecular Formula
C35H38Cl2N8O4

Purity
99%

Structural Formula
Available upon request

Application
Used for the treatment of fungal infections

Residual Solvents
Complies with relevant guidelines

Dosage Strength
32 mcg

Loss on Drying
1.0%

Packaging Type
Sealed in double-layer HDPE bottles or aluminum foil bags

Heavy Metals
<10 ppm

Identification
By IR, complies with standard

Certificate of Analysis
Available with every batch

Pharmacopoeia Standard
USP/EP/BP

Particle Size
D90 10m

Hazard Statement
Non-hazardous under normal conditions of use

Itraconazole ITR 32mcg Trade Information

Minimum Order Quantity
10 Pieces

FOB Port
Jaipur

Payment Terms
Cash Advance (CA), Cash in Advance (CID), Telegraphic Transfer (T/T)

Supply Ability
100 Pieces Per Day

Delivery Time
7 Days

Sample Policy
Contact us for information regarding our sample policy

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

Main Domestic Market
All India

About Itraconazole ITR 32mcg

Packaging Details	Plastic Bottle
Usage/Application	Laboratory
Country of Origin	Made in India
Product Code	EM073-30ST
Packaging Size	30st
Brand	Himedia

Minimum order quantity: 1 Piece

Itraconazole is used to treat certain types of fungal infections. It stops fungi from growing. Common side effects include nausea, vomiting, diarrhea, constipation, and headache. Serious side effects can include liver damage and nerve problems.HiMedia is a bioscience company known for manufacturing a wide range of culture media for microbiology and other related products. They are a leading global brand in microbiology, with a strong presence in over 140 countries. HiMedia is recognized for its commitment to quality, innovation, and affordability in the bioscience field. The product with the catalog number EM073 from HiMedia Laboratories is the Itraconazole Ezy MICa Strip (ITR). DescriptionThe EM073 Ezy MICa Strip is a unique, porous paper strip used for the quantitative determination of the Minimum Inhibitory Concentration (MIC) of Itraconazole against yeast and fungi.

Principle: The strip works based on the principle of dilution and diffusion, creating a stable concentration gradient when placed on an appropriate agar medium.
Concentration Range: The strip is coated with Itraconazole in a concentration gradient ranging from 0.002 mcg/ml to 32 mcg/ml.
Reading Scale: The MIC reading scale in Ag/ml is printed identically on both sides of the strip, along with the three-letter symbol "ITR" for easy identification.
Material Advantages: Unlike traditional plastic strips, the paper material of the Ezy MICa strip allows it to be adsorbed and adhere firmly to the agar surface within 60 seconds, preventing air bubbles from forming underneath. MIC values can often be read without removing the petri dish lid if a translucent medium is used.
Usage: It is intended for in vitro testing, following overnight incubation, to guide physicians in selecting appropriate antifungal therapy.

High Purity and Stringent Quality Standards

Itraconazole ITR 32mcg achieves a purity level of at least 99%, verified by IR identification and provided with a detailed Certificate of Analysis for each batch. It complies with internationally recognized pharmacopoeia standards (USP/EP/BP) and exhibits minimal residual solvents, low heavy metals, and a neutral pH. The product's stability and integrity are ensured through advanced packaging in double-layer HDPE bottles or aluminum foil bags.

Versatile Application in Pharmaceutical Manufacturing

This premium-grade itraconazole powder is formulated for manufacturers producing oral and topical antifungal therapies. Its fine particle size (D90 10m) facilitates uniform blending and dissolution in pharmaceutical processes. The ingredient is ideal for developing a wide range of antifungal products aimed at treating systemic and superficial fungal infections.

Safe Handling, Storage, and Extended Shelf Life

Itraconazole ITR 32mcg is non-hazardous under normal usage conditions. It maintains efficacy and quality when stored in a cool, dry, well-ventilated area protected from light. With a shelf life of three years, this robust formulation is dependable for long-term inventory storage and consistent product performance.

FAQ's of Itraconazole ITR 32mcg:

Q: How should Itraconazole ITR 32mcg be stored to preserve its quality?

A: Store Itraconazole ITR 32mcg in a cool, dry, and well-ventilated place, protected from light. Keeping the product sealed in its original double-layer HDPE bottles or aluminum foil bags will help maintain its stability and prolong its shelf life up to three years.

Q: What is the main pharmaceutical application of Itraconazole ITR 32mcg?

A: Itraconazole ITR 32mcg is primarily used as an active pharmaceutical ingredient in the manufacture of oral and topical antifungal formulations for the treatment of a broad spectrum of fungal infections.

Q: When is Itraconazole ITR 32mcg considered suitable for formulation?

A: Itraconazole ITR 32mcg is suitable for use when a pharmaceutical formulation requires an antifungal agent of high purity (99%) that meets USP/EP/BP standards, with low heavy metals and residual solvents, and precise particle size requirements for optimal processing.

Q: Where can I obtain the Certificate of Analysis for Itraconazole ITR 32mcg?

A: A Certificate of Analysis (CoA) accompanies every batch of Itraconazole ITR 32mcg, ensuring traceability and verification of compliance with quality standards. The CoA can be requested directly from the manufacturer, distributor, or supplier.

Q: What is the benefit of the product's fine particle size (D90 10m)?

A: Fine particle size enhances the uniformity and dispersibility of the active ingredient in pharmaceutical formulations, supporting better absorption, consistency in dosing, and improved final product performance.

Q: How does Itraconazole ITR 32mcg meet pharmacopoeia and regulatory requirements?

A: Itraconazole ITR 32mcg conforms to USP, EP, and BP guidelines, including tests for purity, particle size, identification by IR, limits on heavy metals, loss on drying, and residual solvents, ensuring it fulfills all regulatory and quality demands for pharmaceutical manufacturing.

Q: What is the recommended process for using Itraconazole ITR 32mcg in formulation development?

A: Itraconazole ITR 32mcg should be accurately weighed and blended with excipients during pharmaceutical formulation, ensuring compatibility and stability. Manufacturers should reference the product's Certificate of Analysis and follow standard GMP protocols for optimal integration into oral and topical antifungal products.

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