Name: Ketoconazole IP/BP
Brand: OREX PHARMA PVT. LTD

08045815720

OREX PHARMA PVT. LTD
GST : 27AAACO0984E1ZJ

Product Details:

Ph Level Neutral
Storage Keep tightly closed in a dry and cool place, protected from light and moisture
Molecular Formula C26H28Cl2N4O4
Heavy Metal (%) 20 ppm
Particle Size Pre-micronized (as per requirement)
Loss on Drying 0.5%
Solubility Practically insoluble in water, soluble in methanol, chloroform, ethanol
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Ketoconazole IP/BP Price And Quantity

Minimum Order Quantity 100 Kilograms

Ketoconazole IP/BP Product Specifications

Ph Level Neutral
Molecular Formula C26H28Cl2N4O4
Storage Keep tightly closed in a dry and cool place, protected from light and moisture
Particle Size Pre-micronized (as per requirement)
Loss on Drying 0.5%
Heavy Metal (%) 20 ppm
Type Antifungal
Appearance White to off-white crystalline powder
CAS No 65277-42-1
Solubility Practically insoluble in water, soluble in methanol, chloroform, ethanol
Medicine Name Ketoconazole IP/BP
Poisonous No, but may be harmful if ingested or inhaled in large quantities
HS Code 29332990
EINECS No 265-667-4
Chemical Name 1-Acetyl-4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazine
Melting Point 146-152C
Molecular Weight 531.43 g/mol
Smell Odorless
Shelf Life 36 months from date of manufacture
Color White to off-white
Purity(%) 99%
Structural Formula (Displayed in image)
Grade IP / BP Grade
Usage Pharmaceutical intermediate, antifungal treatment
Physical Form Solid

Microbial Contamination Meets pharmacopeial requirements
Identification Complies with IP/BP standards
Polymorphic Form Crystalline form I (as per pharmacopeia)
Endotoxin Level < 0.25 EU/mg
Stability Data Available on request
Assay (HPLC) 99%
Related Substances 0.5%
Packaging 25 kg HDPE drum / customized
Residue on Ignition 0.1%

Ketoconazole IP/BP 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

Ketoconazole IP/BP is used to treat fungal infections of skin such as athletes foot, jock itch, ringworm and seborrhea. It is also known to have antiandrogen and antiglucocorticoid properties. This is considered as synthetic imidazole antifungal drug which can be consumed orally or applied topically in the form of cream, shampoo, and solution. We provide this chemical in various packaging options as per the several requirements of our valuable clients. Furthermore, this Ketoconazole IP/BP can be availed at reasonable prices.

Strict Quality Assurance

Every batch of Ketoconazole IP/BP is rigorously tested, ensuring it meets IP/BP specifications for assay, related substances, and physical characteristics. Detailed stability data and comprehensive quality documentation are available on request, reflecting our commitment to regulatory compliance and safety.

Versatile Pharmaceutical Applications

Ketoconazole IP/BP is widely utilized as a pharmaceutical intermediate and active antifungal agent. Its high purity and reliable crystalline form make it suitable for both formulation and process development within the pharmaceutical industry.

Customized Packaging and Safe Handling

Supplied in standard 25 kg HDPE drums, Ketoconazole can also be packaged to meet specific requirements. For best results and prolonged shelf life, store the product tightly sealed in cool, dry conditions, protected from light and moisture.

FAQ's of Ketoconazole IP/BP:

Q: How is Ketoconazole IP/BP typically used in the pharmaceutical industry?

A: Ketoconazole IP/BP serves primarily as an antifungal agent in the formulation of medicinal products and as a pharmaceutical intermediate in synthesis processes.

Q: What measures are taken to ensure the quality and safety of Ketoconazole IP/BP?

A: The product is manufactured and tested according to IP/BP standards, with strict controls on residue on ignition, related substances, heavy metals, microbial contamination, and endotoxin levels.

Q: What is the recommended storage condition and shelf life of Ketoconazole IP/BP?

A: Store Ketoconazole IP/BP in a tightly closed container, in a cool, dry place protected from light and moisture. The product maintains its stability for 36 months from the manufacturing date.

Q: When can stability data for Ketoconazole IP/BP be obtained?

A: Comprehensive stability data is available upon request to support regulatory submissions and quality assurance procedures.

Q: Where is the Ketoconazole IP/BP product manufactured and supplied from?

A: This product is manufactured, exported, and supplied by leading pharmaceutical companies based in India, ensuring global quality standards are met.

Q: What benefits does the crystalline form I offer in Ketoconazole IP/BP?

A: Crystalline form I, as per pharmacopeial requirements, ensures consistent pharmaceutical performance, improved handling, and optimal solubility for formulation development.

Q: Is Ketoconazole IP/BP harmful and how should it be handled?

A: While Ketoconazole is non-poisonous, large quantities may be harmful if ingested or inhaled. It should be handled in accordance with standard laboratory safety protocols.

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OREX PHARMA PVT. LTD
GST : 27AAACO0984E1ZJ

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

Phone :08045815720

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