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Pharmaceutical API Intermediates

KetoconazoleC₂₆H₂₈Cl₂N₄O₄

Formula: C₂₆H₂₈Cl₂N₄O₄CAS: 65277-42-1Mol. Wt: 531.43 g/mol
Product NameKetoconazole
SKUVCP-PHR-0002
CategoryPharmaceutical API Intermediates
SubcategoryAntifungals
OriginIndia
ManufacturerVasuDev Chemo Pharma

Export: 1 MT minimum order  ·  Domestic: 220 kg minimum order

About Ketoconazole

Ketoconazole is a synthetic imidazole antifungal agent used in the treatment of fungal infections. As an API intermediate, it is supplied in high purity for formulation into oral tablets, topical creams, and shampoos. VasuDev Chemo Pharma manufactures Ketoconazole (CAS 65277-42-1) at our WHO-GMP compliant facility in Gujarat, India. The product meets USP/BP pharmacopoeial specifications and is supported by a comprehensive Drug Master File. Ketoconazole works by inhibiting ergosterol synthesis in fungal cell membranes, making it effective against a broad spectrum of dermatophytes, yeasts, and dimorphic fungi.

Technical Specifications

ParameterValue
Assay (HPLC)≥ 99.0%
Melting Point148 – 152°C
Loss on Drying≤ 0.5%
Residue on Ignition≤ 0.1%
Heavy Metals (as Pb)≤ 10 ppm
Residual SolventsMeets ICH Q3C guidelines
Related Substances≤ 0.5% total impurities
Optical RotationWithin pharmacopoeial limits

Appearance

White to off-white powder

Molecular Weight

531.43 g/mol

HS Code

2933.29

Applications & Industries

Applications

Oral antifungal tablet formulationTopical cream & ointment manufacturingAnti-dandruff shampoo formulationVeterinary antifungal preparationsCombination dermatological products

Target Industries

PharmaceuticalsDermatology & CosmeceuticalsVeterinary MedicineContract Manufacturing (CDMO)

Safety & Compliance

GHS Classification

Safety Class: Harmful

Signal Word: Warning

GHS07GHS08

Hazard Statements

  • H302 – Harmful if swallowed
  • H361 – Suspected of damaging fertility or the unborn child
  • H370 – Causes damage to organs (liver) through prolonged exposure

Packaging Options & Available Grades

Available Grades

  • Pharmaceutical Grade (USP/BP/IP compliant)
  • Topical Grade

Packaging

  • 1 kg double LDPE bags in fibre drums
  • 5 kg double LDPE bags in fibre drums
  • 25 kg HDPE drums
  • Custom packaging on request

Minimum Order Quantity

1 kg

Certifications & Quality Assurance

ISO 9001:2015

Content to add

Quality assurance details — QC process description, in-house lab testing capabilities, COA (Certificate of Analysis) provided with each shipment, batch traceability.

Documents & Downloads

Content to add

Downloadable documents — Safety Data Sheet (SDS/MSDS), Certificate of Analysis (COA), Technical Data Sheet (TDS), Product Specification Sheet. Each with file type, access level (public / on-request).

Shipping & Export Information

Content to add

Shipping & export details — Export-ready packaging, nearest ports (Kandla, Mundra, Hazira), shipping lead time, Incoterms offered (FOB, CIF, CFR), countries exported to, customs documentation support, HS code for this product.

Frequently Asked Questions

What is Ketoconazole used for?+
Ketoconazole is commonly used for Oral antifungal tablet formulation, Topical cream & ointment manufacturing, Anti-dandruff shampoo formulation. It is suitable for industrial and commercial formulations based on your process requirements.
What is the CAS number of Ketoconazole?+
The CAS number of Ketoconazole is 65277-42-1.
What grades are available for Ketoconazole?+
Available grades include Pharmaceutical Grade (USP/BP/IP compliant), Topical Grade.
What packaging options are available for Ketoconazole?+
Standard packaging includes 1 kg double LDPE bags in fibre drums, 5 kg double LDPE bags in fibre drums, 25 kg HDPE drums, Custom packaging on request.
What is the minimum order quantity (MOQ) for Ketoconazole?+
The typical MOQ for Ketoconazole is 1 kg.
Do you provide COA and technical documents with Ketoconazole?+
Yes. We provide COA and relevant technical documents such as TDS/SDS based on shipment and compliance requirements.

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