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Cefixime Trihydrate API

Price 13500.0 INR/ Piece

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MOQ : 100 Pieces

Cefixime Trihydrate API Specification

Structural Formula
Available on request

Boiling point
Not applicable (decomposes)

Melting Point
Approximately 210C (decomposes)

Loss on Drying
Not more than 5.0%

Storage
Store in cool, dry and well-ventilated area below 25C, protected from light and moisture

Ph Level
4.5 - 6.0 (in solution)

Solubility
Slightly soluble in water, soluble in dimethylformamide

HS Code
29419090

Molecular Formula
C16H15N5O7S23H2O

Poisonous
NO

Particle Size
90% below 50 microns

Heavy Metal (%)
Not more than 0.001% (10 ppm)

Molecular Weight
507.50 g/mol

Taste
Bitter

Smell
Odorless

Color
White to off-white

Shelf Life
3 years from date of manufacture

Medicine Name
Cefixime Trihydrate API

Chemical Name
(6R,7R)-7-{[2-(2-Amino-1,3-thiazol-4-yl)-2-(carboxymethoxyimino)acetyl]amino}-3-ethenyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid trihydrate

CAS No
104376-79-6

Type
Active Pharmaceutical Ingredient

Grade
Pharmaceutical Grade

Usage
Used in the formulation of antibiotic medicines for treatment of bacterial infections

Purity(%)
>= 98%

Appearance
White to off-white powder

Physical Form
Solid

Regulatory Documentation
DMF, WC, GMP and other regulatory documents available on request

Therapeutic Category
Cephalosporin Antibiotic

Residue on Ignition
Not more than 0.5%

Assay
Not less than 98.0% and not more than 102.0% (on anhydrous basis)

Certificate of Analysis
Available with every batch

Stability
Stable under recommended storage conditions

Identification
Complies with standard as per pharmacopeia (USP/EP/JP/IP)

Related Substances
Total impurities: Not more than 1.0%

Packaging
Double polyethylene bags in HDPE drum, custom pack sizes available

Specific Optical Rotation
+46 to +54 (in 0.1N NaOH)

Microbial Limit
Complies with pharmacopeial requirements

Water Content
10.5% - 13.5%

Cefixime Trihydrate 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 Cefixime Trihydrate API

Packaging Size	25Kg
Packaging Type	Bag
CAS Number	79350-37-1
Grade	Pharma Grade
Usage/Application	Bacterial Infections
Chemical Formula	C16H15N5O7S2
Molecular weight	453.452 g/mol

Compliant With International Pharmacopeial Standards

Cefixime Trihydrate API fully complies with the quality and purity guidelines set by USP, EP, JP, and IP, ensuring suitability for global pharmaceutical applications. Every batch is rigorously tested for related substances, microbial safety, and physical characteristics, supported by comprehensive regulatory documentation and certificates.

Secure Packaging and Flexible Supply Options

Our API is packaged in double polyethylene bags within sturdy HDPE drums, offering protection against moisture and contamination. Customizable pack sizes are available to meet client-specific needs, ensuring convenience in handling, storage, and transportation for both small-scale and large-scale manufacturers.

Reliable Stability and Extended Shelf Life

Cefixime Trihydrate exhibits excellent stability under recommended storage conditions-below 25C, protected from light and moisture. With a shelf life of three years, the API maintains its therapeutic efficacy and physical integrity, making it a dependable choice for pharmaceutical formulations.

FAQ's of Cefixime Trihydrate API:

Q: How should Cefixime Trihydrate API be stored and handled?

A: Cefixime Trihydrate API must be kept in a cool, dry, well-ventilated area below 25C, protected from light and moisture. It should remain sealed in its original double polyethylene packaging within an HDPE drum to preserve its stability and prevent contamination.

Q: What are the benefits of using Cefixime Trihydrate API in pharmaceutical manufacturing?

A: This API offers high purity (98%), strict compliance with global pharmacopeial standards, and reliable stability. It is suitable for use in the formulation of effective cephalosporin antibiotics, providing manufacturers with confidence in product quality and regulatory approval.

Q: When is a Certificate of Analysis (CoA) and regulatory documentation available for Cefixime Trihydrate API?

A: A Certificate of Analysis is provided with every batch to ensure consistent quality. Additional regulatory documents such as DMF, WC, and GMP certificates can be supplied upon request to support your regulatory submissions or audits.

Q: What usage guidelines exist for incorporating Cefixime Trihydrate API into antibiotic medicines?

A: Cefixime Trihydrate is primarily used as the key ingredient in cephalosporin antibiotics for treating bacterial infections. Formulators should adhere to pharmacopeial guidelines for dosage and manufacturing processes to ensure safety, efficacy, and compliance.

Q: Where is Cefixime Trihydrate API manufactured and supplied from?

A: Our Cefixime Trihydrate API is produced, exported, and supplied from India, with a focus on serving global pharmaceutical markets as a trusted exporter, importer, manufacturer, and supplier.

Q: What is the process for ensuring the quality and purity of Cefixime Trihydrate API?

A: Each batch undergoes comprehensive testing for assay (98.0%-102.0%), related substances (max 1.0%), residue on ignition (max 0.5%), water content (10.5%-13.5%), and microbial limits, as per pharmacopeial requirements. Heavy metals and physical parameters are also closely monitored to maintain consistent quality.

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