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Fluconazole Powder API

Price 9000.0 INR/ Piece

Get a Price/Quote

MOQ : 100 Pieces

Fluconazole Powder API Specification

Smell
Odorless

Melting Point
138-140C

Shelf Life
5 years when properly stored

Solubility
Slightly soluble in water, freely soluble in methanol, ethanol, acetone, and chloroform

EINECS No
617-984-5

Taste
Bitter

Color
White to off-white

HS Code
29420090

Ph Level
4.0-8.5 (1% aqueous solution)

Poisonous
No (when used as directed)

Boiling point
Not applicable/decomposes

Loss on Drying
0.5% max

Storage
Store in a cool, dry, well-ventilated area, away from light

Particle Size
D90 < 10 microns (customizable on request)

Heavy Metal (%)
NMT 0.001%

Structural Formula
(Provide upon request or see structural diagram)

Molecular Formula
C13H12F2N6O

Molecular Weight
306.27 g/mol

Medicine Name
Fluconazole Powder API

Chemical Name
2-(2,4-difluorophenyl)-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol

CAS No
86386-73-4

Type
Antifungal Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Used in the treatment of fungal and yeast infections

Purity(%)
99% min

Appearance
White to off-white crystalline powder

Physical Form
Powder

Bulk Density
0.38-0.56 g/ml

Microbial Limits
Complies with pharmacopeial standards

Endotoxins
NMT 0.5 EU/mg

TYMC (Total Yeast and Mold Count)
NMT 100 CFU/g

Chloride (%)
NMT 0.014%

Water Content (by KF)
NMT 0.5%

TAMC (Total Aerobic Microbial Count)
NMT 1000 CFU/g

Sulphated Ash
NMT 0.1%

pH of 1% Solution
4.0-8.5

Identity by IR
Corresponds to standard

Specific Optical Rotation
Not specified/not applicable

Residual Solvents
Complies with ICH Q3C guidelines

Related Substances (HPLC)
Total impurities NMT 1.0%

Assay (HPLC)
98.0% - 102.0%

Fluconazole Powder API Trade Information

Minimum Order Quantity
100 Pieces

Supply Ability
100 Pieces Per Day

Delivery Time
7 Days

Sample Available
No

Sample Policy
Contact us for information regarding our sample policy

About Fluconazole Powder API

Grade Standard	USP
Purity	>99%
Packaging Size	25Kg
Packaging Type	Bag
CAS Number	86386-73-4
Grade	Pharma Grade
Manufacturer	pharma
Shelf Life	5 yr
Usage/Application	Fungal and yeast infection
Minimum Order Quantity	5 Kg

Product Specification

Grade Standard	USP
Packaging Size	5Kg
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

Product DescriptionFluconazole is an antifungal medication used for a number of fungal infections.

Superior Efficacy and High Purity

Fluconazole Powder API boasts a minimum purity of 99%, with assays consistently ranging between 98.0% and 102.0%. Its compliance with modern pharmacopeial standards and strict control of total impurities (NMT 1.0%) ensure reliable, potent antifungal capabilities in formulation development.

Strict Quality and Safety Standards

Manufactured under vigilant controls, this API meets rigorous residual solvent requirements set by ICH Q3C, and demonstrates low endotoxins (NMT 0.5 EU/mg), minimal heavy metals (NMT 0.001%), and excellent microbial limits (TAMC 1000 CFU/g, TYMC 100 CFU/g). Each batch is accompanied by comprehensive analytical documentation.

Versatile Application and Reliable Supply

With customizable particle size (D90 < 10 microns) and broad solubility in organic solvents, Fluconazole Powder API is ideal for various pharmaceutical formulations. Exported, imported, and supplied from India, we ensure timely delivery and global availability to manufacturers and researchers seeking effective antifungal APIs.

FAQ's of Fluconazole Powder API:

Q: What is Fluconazole Powder API, and how is it typically used?

A: Fluconazole Powder API is a pharmaceutical grade antifungal active ingredient, effective in treating a range of fungal and yeast infections. It is commonly used by licensed manufacturers to develop oral, intravenous, and topical antifungal medications.

Q: How is the identity and quality of Fluconazole Powder API verified?

A: The API's identity is confirmed by Infrared Spectroscopy (IR), while its chemical purity is assessed using HPLC with a specified assay between 98.0% and 102.0%. Each batch meets strict standards for impurities, microbial content, and residual solvents to ensure quality and compliance.

Q: What are the storage and shelf life requirements for this API?

A: Fluconazole Powder API should be stored in a cool, dry, well-ventilated area, shielded from light. Under these conditions, the product maintains its quality and efficacy for up to five years.

Q: When can manufacturers benefit from using Fluconazole Powder API in formulations?

A: This API is especially beneficial during the development and production of antifungal medicines, where high potency and purity are required. Its customizable particle size supports bespoke formulation needs.

Q: Where can Fluconazole Powder API be exported or supplied from?

A: This product is manufactured, exported, and supplied from India, with reliable logistics and supply chains serving pharmaceutical companies, researchers, importers, and distributors worldwide.

Q: What benefits does Fluconazole Powder API offer for pharmaceutical product development?

A: The key benefits include high chemical purity (99%), low total impurities, compliance with global pharmacopeial and ICH guidelines, and broad solubility in organic solvents, making it versatile for various dosage forms.

Q: How does the manufacturing process ensure product safety and compliance?

A: Advanced quality controls are applied throughout production to meet pharmacopeial microbial limits, minimize heavy metals and endotoxins, and confirm the absence of hazardous levels of residual solvents, ensuring safe and compliant pharmaceutical-grade output.

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