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Gentamicin Sulphate Api

Name: Gentamicin Sulphate Api
Brand: Vertex Chemical Corporation
Price: 15400.0 INR
Availability: InStock

Price 15400.0 INR/ Gram

Get a Price/Quote

MOQ : 25000 Kilograms

Gentamicin Sulphate Api Specification

Standard
IP/BP/USP

Identification
Meets pharmacopeial requirements (IR/chemical tests)

CAS Number
1405-41-0

Usage
Pharmaceutical raw material for parenteral, topical and ophthalmic preparations

Regulatory Compliance
GMP, DMF available

Product Name
Gentamicin Sulphate API

Bacterial Endotoxins
Less than 0.175 IU/mg

Molecular Formula
C21H43N5O7xH2SO4

Loss on Drying
Not more than 8.0% (anhydrous basis)

Packaging
Fibre drums with double polyethylene bags (as per requirement)

Shelf Life
36 months from date of manufacture

Assay (Potency)
Not less than 590 g/mg (calculated on anhydrous basis)

pH (2% solution)
3.5 - 5.5

Residue on Ignition
Not more than 1.0%

Certificate of Analysis
Provided with each batch

Manufacturing Grade
Pharmaceutical Grade

Solubility
Freely soluble in water, practically insoluble in acetone and in ethanol (96%)

Molecular Weight
Variable (mixture of related gentamicins, commonly as sulphate salt)

Sulphate Content
As per pharmacopeial standard

Heavy Metals
Not more than 20 ppm

Appearance
White to almost white crystalline powder

Storage
Store in tightly closed containers, protected from moisture

Gentamicin Sulphate Api Trade Information

Minimum Order Quantity
25000 Kilograms

FOB Port
Nava Sheva Port

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

Supply Ability
10000 Kilograms Per Week

Delivery Time
8 Days

Sample Available
No

Sample Policy
Within a certain price range free samples are available

Packaging Details
Drum

Main Export Market(s)
Asia, Eastern Europe, Western Europe, Middle East, Africa

Main Domestic Market
All India

Certifications
All Necessary Documents

About Gentamicin Sulphate Api

Topical gentamicin is an antibiotic that is commonly used to treat certain bacterial skin infections, such as impetigo or folliculitis. It is also used to treat infections due to certain skin conditions such as eczema or psoriasis, or to treat infected burns, sores, or wounds.

Strict Pharmacopeial Compliance

Gentamicin Sulphate API is meticulously manufactured to meet Indian (IP), British (BP), and United States (USP) pharmacopeial standards. Each batch undergoes comprehensive testing for heavy metals, endotoxins, residuals, and identity. Rigorous compliance ensures safety, efficacy, and suitability for regulated pharmaceutical markets.

Optimal Stability and Shelf Life

With a shelf life of up to 36 months from the date of manufacture, Gentamicin Sulphate API maintains its quality and potency over time. The product is securely packaged in fibre drums with double polyethylene bags, protecting it against moisture and contaminants during storage and transportation.

Flexible Pharmaceutical Applications

This API is utilized as a raw material in the formulation of various parenteral, ophthalmic, and topical antibiotic preparations. Its high solubility in water and stability make it highly adaptable for compounding and large-scale manufacturing, ensuring broad usability for pharmaceutical developers and suppliers.

FAQ's of Gentamicin Sulphate Api:

Q: How is Gentamicin Sulphate API packaged to maintain product integrity?

A: Gentamicin Sulphate API is securely packed in fibre drums with double polyethylene bags. This dual-layer packaging safeguards the product against moisture and contamination during transit and storage, ensuring stability and quality are preserved.

Q: What are the primary applications of Gentamicin Sulphate API in the pharmaceutical industry?

A: This API serves as a raw material for manufacturing parenteral (injectable), topical, and ophthalmic antibiotic formulations. Its robust pharmacological profile and compliance with pharmacopeial standards make it suitable for a variety of medicinal products targeting bacterial infections.

Q: When should Gentamicin Sulphate API be used following its date of manufacture?

A: The product maintains its potency and safety for up to 36 months from the date of manufacture. It should be used within this shelf life and stored in tightly closed containers to ensure continued efficacy.

Q: Where is Gentamicin Sulphate API typically exported or supplied from?

A: This API is manufactured and exported from India by GMP-compliant facilities. It is available to global pharmaceutical companies, suppliers, and distributors adhering to regulatory requirements.

Q: What process ensures that Gentamicin Sulphate API meets pharmacopeial standards?

A: Every batch undergoes strict quality control and analysis, including tests for heavy metals, bacterial endotoxins, residue on ignition, and assay. A Certificate of Analysis (CoA) is provided with each shipment, confirming that all critical parameters meet IP/BP/USP standards.

Q: How does Gentamicin Sulphate API benefit pharmaceutical manufacturers?

A: Pharmaceutical companies benefit from its high purity, regulatory compliance, and reliable supply. Availability of a DMF and consistent quality documentation facilitates regulatory submissions and product registration in multiple markets.

Q: What should be considered regarding storage and handling of Gentamicin Sulphate API?

A: It is essential to store the product in tightly closed containers, away from moisture, as recommended on the label. Adhering to storage guidelines helps preserve the chemical stability and effectiveness of the API throughout its shelf life.

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