Fluconazole USP EP

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Fluconazole USP EP Specification

EINECS No
627-032-6

Color
White to off-white

Structural Formula
CHCHNCFCHCH(OH)

Heavy Metal (%)
Not more than 20 ppm

Particle Size
90% passing through 30 m

Taste
Bitter

HS Code
2933.99.80

Melting Point
138-140C

Poisonous
Non-poisonous when used as directed

Solubility
Soluble in methanol; slightly soluble in water

Boiling point
Not applicable (decomposes)

Storage
Store in a cool dry place away from direct sunlight

Ph Level
5.5-7.5 (in solution)

Molecular Weight
306.27 g/mol

Smell
Odorless

Shelf Life
2 years from the date of manufacture

Molecular Formula
C13H12F2N6O

Loss on Drying
Not more than 0.5%

Medicine Name
Fluconazole USP EP

Chemical Name
Fluconazole

CAS No
86386-73-4

Type
Antifungal Agent

Grade
Pharmaceutical Grade

Usage
Treatment of fungal infections

Purity(%)
99%

Appearance
White to off-white crystalline powder

Physical Form
Solid

About Fluconazole USP EP

Owing to our rich industry experience, we have been able to offer our valuable clients supreme quality Fluconazole USP/EP. The offered chemical is used for the treatment and prophylaxis of fungal infections. Very slightly soluble in water and alcohol, this chemical appears as a white crystalline powder. Processed using the utmost quality basic material and latest production procedures at par with the set industry standards, this Fluconazole USP/EP is offered at industry leading price to the clients.

Features:

Precise pH value
Long shelf life
High effectiveness
Accurate composition

Product details

Chemical Name	a.-(2,4-Difluorophenyl)-a-(1H-1,2,4,-triazol-1-ylmethyl)-1H-1,2 ,4-triazole-1-ethanol
Molecular Formulae	C13H12F2N6O
Mol. Wt.	306.27
CAS No	86386-73-4
Therapeutic Category	Antifungal

Pharmaceutical Grade Assurance

Fluconazole USP EP is manufactured under strict quality controls, ensuring a purity level of 99% and compliance with international standards for heavy metals, pH, and appearance. Supplied as a fine crystalline powder, it offers consistency and reliability for pharmaceutical formulations, meeting the requirements set by both the USP and EP.

Key Applications and Usage

Primarily used for the treatment of fungal infections, Fluconazole USP EP acts efficiently against a wide spectrum of fungi. Its high solubility in methanol and stability under recommended storage conditions make it ideal for use by manufacturers, exporters, and suppliers in the pharmaceutical industry.

Safe Storage and Handling

To maintain its efficacy, Fluconazole USP EP should be stored in a cool, dry place away from direct sunlight. It is non-poisonous when used as directed, and its shelf life extends to two years from the date of manufacture, providing a dependable solution for long-term inventory.

FAQs of Fluconazole USP EP:

Q: How should Fluconazole USP EP be stored to maintain its quality?

A: Fluconazole USP EP should be stored in a cool, dry place, protected from direct sunlight. Proper storage conditions help preserve its purity and effectiveness throughout its two-year shelf life.

Q: What is Fluconazole USP EP used for in the pharmaceutical industry?

A: Fluconazole USP EP is mainly used as an antifungal agent for the treatment of various fungal infections. Its pharmaceutical grade ensures reliability for use in medicinal formulations manufactured globally.

Q: When should Fluconazole USP EP be utilized in a formulation?

A: Fluconazole USP EP should be used as directed in pharmaceutical formulations intended to treat fungal infections. Its use must comply with applicable pharmacopeial standards and directions for safe and effective results.

Q: Where does the manufacturing of Fluconazole USP EP typically take place?

A: This product is manufactured, exported, and supplied from India by reputable pharmaceutical companies following USP and EP guidelines to ensure global quality compliance.

Q: What is the process for ensuring the purity of Fluconazole USP EP?

A: Fluconazole USP EP undergoes rigorous quality control processes, including testing for purity, heavy metals (no more than 20 ppm), loss on drying, and particle size, ensuring each batch meets pharmaceutical standards.

Q: What are the benefits of using Fluconazole USP EP?

A: The primary benefits include its high purity (99%), proven antifungal efficacy, stability in storage, and compliance with recognized quality standards, making it a preferred choice in pharmaceutical manufacturing.

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