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Fluconazole API

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Fluconazole API Specification

Smell
Odorless

HS Code
29332990

Heavy Metal (%)
Not more than 0.001%

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

Solubility
Freely soluble in methanol and ethanol, slightly soluble in water, insoluble in hexane

Loss on Drying
Not more than 0.5%

Molecular Weight
306.27 g/mol

Shelf Life
5 years from date of manufacture

Molecular Formula
C13H12F2N6O

Color
White to off-white

Structural Formula
C13H12F2N6O

Poisonous
Non-poisonous at pharmaceutical dosages

Melting Point
137-141°C

Ph Level
5.0 - 7.0 (1% solution)

Particle Size
90% passes through 40 mesh

EINECS No
629-298-3

Medicine Name
Fluconazole API

Chemical Name
Fluconazole

CAS No
86386-73-4

Type
Active Pharmaceutical Ingredient

Grade
Pharmaceutical Grade

Usage
Antifungal agent used for the treatment of fungal and yeast infections

Purity(%)
99.0% Min

Appearance
White to off-white crystalline powder

Physical Form
Powder

Specific Rotation
Not more than ± 1.0°

Microbial Limits
Total aerobic microbial count NMT 1000 cfu/g, total yeast & mold count NMT 100 cfu/g

Certificate of Analysis
Available with every batch

Packing Detail
Double polyethylene bags in HDPE drum or as per customer requirements

Endotoxin Level
< 5.0 EU/g

Residual Solvents
Complies with ICH guidelines

Bulk Density
0.20 - 0.40 g/ml

Assay (on dried basis)
98.0% - 102.0%

Related Substances
Total impurities not more than 0.5%

Identification
By IR and HPLC; complies with standard

Fluconazole API Trade Information

Supply Ability
100 Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Fluconazole API

Packaging Size	25Kg
Packaging Type	Bag
CAS Number	86386-73-4
Grade	Pharma Grade
Usage/Application	Fungal and yeast infection
Chemical Formula	C13H12F2N6O
Molecular weight	306.271 g/mol
Form	Powder
Color	White

Available Grade - BP/EP/USPiWe have high-end expertise in manufacturing and supplying quality-centric Fluconazole USP. The outstanding quality of this product also includes its high end reliability and durability. We adhere to all the norms in order to create customer centrici products which are meant to perform to the utmost. The prices at which this product is offered are nominal and highly affordable which is widely appreciated by our clients.

Features:

Compact design
Reliable
Robust

Pharmaceutical-Grade Quality You Can Trust

Fluconazole API is manufactured according to the highest pharmaceutical standards, ensuring a minimum purity of 99.0% and strict adherence to key safety and efficacy parameters. Each batch is validated for compliance with pharmacopeial specifications, including related substances, microbial limits, and heavy metals. Rigorous testing protocols guarantee reliable performance in antifungal formulations.

Secure Packing and Certified Consistency

This active ingredient is securely packed in double polyethylene bags within HDPE drums, or as per specific customer requirements, safeguarding product quality throughout its shelf life. A complete Certificate of Analysis is provided with every batch, offering full transparency and confidence in consistent potency and safety.

FAQ's of Fluconazole API:

Q: How is Fluconazole API identified and tested for quality?

A: Fluconazole API is identified using Infrared (IR) spectroscopy and High-Performance Liquid Chromatography (HPLC), ensuring it meets established pharmacopoeial standards for authenticity and purity.

Q: What are the main pharmaceutical uses of Fluconazole API?

A: Fluconazole API is primarily used as an antifungal agent for the treatment and prevention of various fungal and yeast infections in pharmaceutical formulations.

Q: When should the product be used after manufacture, and how should it be stored?

A: Fluconazole API should be used within five years from the date of manufacture. It must be stored in a cool, dry, and well-ventilated place, protected from light to maintain its stability and potency.

Q: Where is the Fluconazole API produced and how is it exported?

A: Manufactured in India, the product is supplied globally to pharmaceutical companies, exporters, and importers in secure packaging, meeting international quality and safety requirements.

Q: What is the process for obtaining a Certificate of Analysis?

A: A Certificate of Analysis is provided with every batch shipped, detailing the specific analysis results and confirming compliance with required standards for purity, microbial count, and residual solvents.

Q: How does using your Fluconazole API benefit pharmaceutical manufacturers?

A: Pharmaceutical manufacturers benefit from high-purity, consistently tested Fluconazole API that assures safety, therapeutic efficacy, and regulatory compliance, which is crucial for the development of high-quality antifungal medications.

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