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Sertaconazole API

Price 19000.00 INR/ Kilograms

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MOQ : 25 Kilograms

Sertaconazole API Specification

EINECS No
620-546-5

Shelf Life
36 months

Molecular Formula
C20H15Cl3N2O2S

Smell
Odorless

Color
White to off-white

Solubility
Insoluble in water, freely soluble in methanol and ethanol

Molecular Weight
453.77 g/mol

Storage
Store in tightly sealed container, protected from light and moisture, at room temperature (2025C)

HS Code
29420090

Structural Formula
C20H15Cl3N2O2S

Heavy Metal (%)
NMT 0.001%

Loss on Drying
NMT 0.5%

Poisonous
NO

Particle Size
NMT 10 micron

Melting Point
155-160 C

Medicine Name
Sertaconazole

Chemical Name
()-(7-Chlorobenzo[b][1,2]benzisothiazol-3-yl)-4-(2,4-dichlorophenyl)-1,3-dioxolan-2-ylmethanamine

CAS No
99592-32-2

Type
Active Pharmaceutical Ingredient (API)

Grade
Pharmaceutical Grade

Usage
Antifungal, treatment of skin fungal infections

Purity(%)
> 99%

Appearance
White to off-white crystalline powder

Physical Form
Solid

Microbial Limit
Complies as per pharmacopeia

Bacterial Endotoxins
Meets specified limit

Packing
HDPE container or double PE bag

Assay (By HPLC)
Not less than 99.0%

Residue on Ignition
NMT 0.1%

Identification
Complies with standard (IR & HPLC) as per pharmacopeia

Related Substances
Total impurities NMT 0.5%

Sertaconazole API Trade Information

Minimum Order Quantity
25 Kilograms

FOB Port
NHAVA SHEVA MUMBAI

Payment Terms
Cash Advance (CA), Cash in Advance (CID)

Supply Ability
1000 Kilograms Per Month

Delivery Time
5 Days

Sample Policy
If order is confirmed we will reimburse the sample cost

Packaging Details
DRUM

Main Export Market(s)
Asia, Australia, Central America, North America, South America, Eastern Europe, Western Europe, Middle East, Africa

Main Domestic Market
All India

Certifications
ALL

About Sertaconazole API

Secnidazole API is an effective medicine to treat infections caused by protozoa and certain strains of anaerobic bacteria.Secnidazole is an antibiotic that works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Excellent Purity and Quality Assurance

Sertaconazole API is manufactured and tested to meet or exceed pharmaceutical grade requirements, with an assay of not less than 99% by HPLC and total impurities capped at 0.5%. Compliance with pharmacopeial standards (including IR and HPLC identification) assures quality, safety, and consistency for manufacturers.

Reliable Microbial and Endotoxin Compliance

Each batch of Sertaconazole undergoes strict microbial and endotoxin testing, conforming with pharmacopeia recommendations. These measures ensure that the product remains free of harmful contamination, making it suitable for safe formulation into topical treatments for skin fungal infections.

Optimized Packaging for Stability

The API is packaged in high-density polyethylene (HDPE) containers or double polyethylene (PE) bags, which provide robust protection from moisture and light. This helps maintain its physical and chemical stability, extending its shelf life to 36 months when stored properly at room temperature.

FAQ's of Sertaconazole API:

Q: How should Sertaconazole API be stored to maintain its effectiveness?

A: Sertaconazole should be stored tightly sealed in its original HDPE container or double PE bag, protected from light and moisture, and kept at room temperature (20-25C) to ensure optimal stability throughout its 36-month shelf life.

Q: What is the recommended process for identifying Sertaconazole API as per pharmacopeia?

A: Sertaconazole's identity is established using Infrared (IR) spectroscopy and High-Performance Liquid Chromatography (HPLC), fully complying with the latest pharmacopeial standards for authenticity and quality control.

Q: When can Sertaconazole API be used in pharmaceutical manufacturing?

A: Sertaconazole API is ready for use upon confirmation of compliance with assays (not less than 99% by HPLC), limits on impurities, particle size (NMT 10 micron), and other standard tests detailed in the certificate of analysis.

Q: Where is Sertaconazole API primarily utilized?

A: This API is predominantly used in the pharmaceutical industry for the formulation of topical antifungal medications intended for managing various skin fungal infections.

Q: What are the main benefits of using Sertaconazole API with >99% purity?

A: High-purity Sertaconazole ensures maximal antifungal effectiveness and minimizes the risk of side effects resulting from impurities, providing a reliable foundation for safe and effective skin infection treatments.

Q: How is Sertaconazole API packaged for export and transport?

A: It is securely packed in HDPE containers or double PE bags to prevent contamination from moisture and environmental factors during shipping and handling.

Q: What makes Sertaconazole API a suitable choice for pharmaceutical companies?

A: Its rigorous compliance with pharmacopeia standards, excellent purity, controlled microbial content, and convenient solid form make Sertaconazole an ideal choice for manufacturers, distributors, and other stakeholders seeking quality and reliability.

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