Name: Fluconazole BP/EP/USP
Brand: OREX PHARMA PVT. LTD

08045815720

OREX PHARMA PVT. LTD
GST : 27AAACO0984E1ZJ

Product Details:

Solubility Soluble in acetone, methanol, and slightly soluble in water
Molecular Weight 306.27 g/mol
Smell Odorless
Melting Point 137-141C
Molecular Formula C13H12F2N6O
Structural Formula See image above
Ph Level Neutral (approx. pH 7 at 1% solution)
Share Your Product:

Get a Price/Quote

Request To Call Back Send Inquiry

Fluconazole BP/EP/USP Price And Quantity

Minimum Order Quantity 100 Kilograms

Fluconazole BP/EP/USP Product Specifications

Heavy Metal (%) 0.001%
Poisonous NO
Chemical Name Fluconazole
CAS No 86386-73-4
Storage Store in a cool, dry place, tightly closed
HS Code 29332990
Physical Form Solid
Loss on Drying 0.5%
Shelf Life 5 years
Appearance White to off-white crystalline powder
Purity(%) >= 99%
Taste Practically tasteless
Particle Size Not less than 90% passes through 40 mesh
Type Antifungal Agent
Color White to off-white
Medicine Name Fluconazole
Grade BP/EP/USP
Smell Odorless
Molecular Weight 306.27 g/mol
Solubility Soluble in acetone, methanol, and slightly soluble in water
Usage Used in treatment of fungal infections
Melting Point 137-141C
Molecular Formula C13H12F2N6O
Structural Formula See image above
Ph Level Neutral (approx. pH 7 at 1% solution)

Water Content 0.5%
Packaging HDPE drums with double polyethylene bags or as required by customer
Assay 98.0% to 102.0% (on dried basis)
Microbial Limit Complies with pharmacopeial standards
Identification IR spectrum complies with reference spectrum
Endotoxin Level < 0.25 IU/mg
Residual Solvents Complies with ICH guidelines
Related Substances Total impurities 0.5%

Fluconazole BP/EP/USP Trade Information

Payment Terms Cash in Advance (CID)
Supply Ability 5000 Kilograms Per Month
Delivery Time 10 Days
Main Domestic Market All India

Product Description

Fluconazole BP/EP/USP is used to prevent and treat a variety of fungal and yeast infections. It helps in the prevention of infection by killing the sensitive fungi by interfering with the formation of the fungal cell membrane. The dosage should be taken by mouth with or without food, as per doctors advice. Minor, short-lived side effects like Nausea, vomiting, diarrhea, stomach upset/pain, headache, dizziness, or hair loss may occur. Avoid using this Fluconazole BP/EP/USP without consultation if allergic, pregnant or breastfeeding.

Quality and Compliance

Fluconazole BP/EP/USP adheres to the highest quality benchmarks, including strict control over related substances, residual solvents, microbial limits, and heavy metals. Its IR spectrum matches the reference, and all batches conform to ICH and pharmacopeial guidelines, ensuring reliability and safety for pharmaceutical applications.

Applications and Effectiveness

Fluconazole is highly effective against various fungal infections and is an essential component in antifungal therapies worldwide. Its excellent purity (99%), solubility in acetone and methanol, and neutral pH make it suitable for multiple pharmaceutical formulations, guaranteeing optimal patient outcomes.

Safe Packaging and Extended Shelf Life

To ensure safe transit and product stability, Fluconazole is packaged in HDPE drums lined with double polyethylene bags. When stored properly, it maintains potency for up to five years, making it an excellent choice for manufacturers, suppliers, and exporters requiring consistent quality over extended periods.

FAQ's of Fluconazole BP/EP/USP:

Q: How is Fluconazole BP/EP/USP identified and verified for quality?

A: Fluconazole BP/EP/USP is identified using IR spectroscopy, ensuring its spectrum matches the reference. The product also undergoes rigorous testing for purity, water content, related substances, and other critical parameters to comply with BP/EP/USP standards.

Q: What are the main pharmaceutical benefits of using Fluconazole BP/EP/USP?

A: Fluconazole is a potent antifungal agent used to treat a wide variety of fungal infections. Its high assay (98.0%-102.0%), purity (99%), and low impurity levels provide excellent efficacy and safety in pharmaceutical formulations.

Q: When and where should Fluconazole BP/EP/USP be stored to maintain its shelf life?

A: Fluconazole should be stored in tightly closed containers in a cool, dry place. Proper storage maintains product integrity and potency for up to five years as specified in its shelf life.

Q: What packaging solutions are available for Fluconazole?

A: Fluconazole BP/EP/USP is typically supplied in HDPE drums lined with double polyethylene bags. Customized packaging solutions are also available based on specific customer requirements.

Q: What makes Fluconazole BP/EP/USP compliant with international pharmaceutical standards?

A: It meets comprehensive BP, EP, and USP monograph specifications: low total impurities (0.5%), controlled water content, minimal heavy metal content (0.001%), endotoxin levels below 0.25 IU/mg, and strict microbial limits, ensuring suitability for pharmaceutical use.

Q: How is Fluconazole BP/EP/USP typically used in medicine manufacturing?

A: Manufacturers incorporate Fluconazole BP/EP/USP into solid and liquid dosage forms for the treatment of fungal infections, thanks to its stability, neutral pH, and favorable solubility profile in formulation processes.

Q: What are the physical characteristics of Fluconazole BP/EP/USP?

A: It appears as a white to off-white crystalline solid, is odorless, practically tasteless, has a melting point of 137-141C, is slightly soluble in water, and passes through a 40-mesh particle size screen, meeting pharmaceutical processing requirements.

Tell us about your requirement

Price:

Quantity

Select Unit

50
100
200
250
500
1000+

Additional detail

Mobile number

Other Products in 'Active Pharma Ingredients' category

LevoSulbutamol Sulphate IP/IHS Minimum Order Quantity : 100 Grade : Other, Pharmaceutical Grade Smell : Other, Odorless Molecular Weight : 337.4 g/mol (base), 239.31 g/mol (sulphate form calculated separately) Solubility : Soluble in water, freely soluble in methanol Usage : Bronchodilator, treatment of asthma and COPD Melting Point : 234238C Molecular Formula : C13H21NO3H2SO4 Structural Formula : [See Image Provided] Heavy Metal (%) : 0.001% Poisonous : Other, No (therapeutic doses) HS Code : 29221990 Chemical Name : (R)4[2(tertbutylamino)1hydroxyethyl]2(hydroxymethyl)phenol sulfate CAS No : 34391043 Storage : Other, Store in cool, dry, wellventilated area, protected from light Loss on Drying : 0.5% Physical Form : Solid Purity(%) : 98% Appearance : White to offwhite powder Shelf Life : 23 years when properly stored Particle Size : 40 mesh (customizable) Type : Other, Pharmaceutical API Color : White Boiling point : Not Applicable (Decomposes on heating) Medicine Name : Levo Sulbutamol Sulphate Ph Level : 4.0 6.0 (1% solution) EINECS No : 2514680 Taste : Other , Slightly bitter

Send Inquiry

Fenofibrate IP/BP Minimum Order Quantity : 100 Grade : Other, IP/BP Smell : Other, Odourless Molecular Weight : 360.83 g/mol Solubility : Practically insoluble in water, soluble in methanol, ethanol, and chloroform Usage : Used for lowering cholesterol and triglyceride (fat) levels in the blood Melting Point : 7982C Molecular Formula : C20H21ClO4 Structural Formula : (See image above structure) Heavy Metal (%) : 0.001% Poisonous : Other, Nonpoisonous as raw material but for drug manufacture only HS Code : 29420090 Chemical Name : Isopropyl 2[4(4chlorobenzoyl)phenoxy]2methylpropanoate CAS No : 49562289 Storage : Other, Store in tightly closed container, cool and dry place, protected from light Loss on Drying : 0.5% Physical Form : Solid Purity(%) : 99% Appearance : White to offwhite powder Shelf Life : 5 years if properly stored Particle Size : Micronized, D90 < 10 m Type : Other, Active Pharmaceutical Ingredient (API) Color : Other, White to offwhite Boiling point : Not applicable (decomposes) Medicine Name : Fenofibrate IP/BP Ph Level : Neutral (6.5 7.5) EINECS No : 15927324530 Taste : Other , Tasteless

Send Inquiry

Glimepiride IP/BP Minimum Order Quantity : 100 Grade : Other, IP/BP (Indian / British Pharmacopoeia) Smell : Other, Odorless Molecular Weight : 490.62 g/mol Solubility : Practically insoluble in water, soluble in dimethylformamide, slightly soluble in methanol Usage : Used as an oral antidiabetic drug (sulfonylurea class) Melting Point : 207209C Molecular Formula : C24H34N4O5S Structural Formula : As shown in image Heavy Metal (%) : 20 ppm Poisonous : Other, No (when used as prescribed) HS Code : 29420090 Chemical Name : Glimepiride CAS No : 93479971 Storage : Other, Store in a cool, dry place, away from light Loss on Drying : 0.5% Physical Form : Solid Purity(%) : 99% Appearance : White to offwhite crystalline powder Shelf Life : 5 years Particle Size : Micronized grade available Type : Other, Pharmaceutical Raw Material / API Color : Other, White to offwhite Boiling point : Not applicable (decomposes) Medicine Name : Glimepiride IP/BP Ph Level : Not applicable / not specified EINECS No : No data available Taste : Other , No data available

Send Inquiry

Ambroxol HCl Minimum Order Quantity : 100 Grade : Other, Pharmaceutical Grade Smell : Other, Odorless Molecular Weight : 414.56 g/mol Solubility : Freely soluble in water, soluble in methanol, practically insoluble in acetone, ethanol Usage : Expectorant, mucolytic therapy in respiratory tract diseases Melting Point : 233237C Molecular Formula : C13H18Br2N2OHCl Structural Formula : See image Heavy Metal (%) : < 0.001% Poisonous : Other, Nonpoisonous at therapeutic doses HS Code : 29224990 Chemical Name : Trans4[(2amino3,5dibromobenzyl)amino]cyclohexanol hydrochloride CAS No : 23828924 Storage : Other, Store in a cool, dry place, protected from light Loss on Drying : < 0.5% Physical Form : Solid Purity(%) : 99% Appearance : White to almost white crystalline powder Shelf Life : 3 years Particle Size : Typically < 10 micron Type : Other, Active Pharmaceutical Ingredient (API) Color : White Boiling point : Not available (decomposes before boiling) Medicine Name : Ambroxol HCl Ph Level : 4.5 6.0 (1% solution) EINECS No : 2458429 Taste : Bitter

Send Inquiry

SEND INQUIRY CALL ME FREE

Quick Inquiry

Quick Links

Contact Details

OREX PHARMA PVT. LTD
GST : 27AAACO0984E1ZJ

Pisal House, Stadium Road, Near CIDCO Bus StandThane - 400601, Maharashtra, India

Phone :08045815720

Send Inquiry