Active Pharmaceutical Ingredient

Isepamicin Sulfate API Manufacturer and Supplier in India

CAS: 67814-76-0 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Isepamicin Sulfate API Manufacturer and Supplier in India — Mediocon Inc
Isepamicin Sulfate API Manufacturer and Supplier in India

Product Overview

CAS No: 67814-76-0 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

MEDIOCON INC – Isepamicin Sulfate is an aminoglycoside antibiotic pharmaceutical active ingredient derived from the gentamicin family. It has potent antibacterial activity against a range of Gram-negative and certain Gram-positive bacteria and has been investigated for use in serious bacterial infections.

Isepamicin Sulfate API

Isepamicin Sulfate is a semisynthetic aminoglycoside antibiotic structurally related to gentamicin. It was developed with the objective of providing antibacterial activity while improving resistance to several aminoglycoside-inactivating enzymes.

The compound acts primarily by interfering with bacterial protein synthesis, resulting in inhibition of bacterial growth and, at effective concentrations, bacterial cell death.

Chemical Information

Product Name: Isepamicin Sulfate
CAS Number: 67814-76-0
Molecular Formula: C₂₂H₄₃N₅O₁₂ · xH₂SO₄
Molecular Weight: Not reliably available / Cannot be verified
Chemical Class: Aminoglycoside Antibiotic
Pharmacological Class: Antibacterial Agent
Salt Form: Sulfate
Parent Compound: Isepamicin
Synonyms: Isepamicin Sulfate, Isepamicin Sulphate, Isepamicin Sulfate Salt

Mechanism of Action

Isepamicin Sulfate acts by binding to the 30S bacterial ribosomal subunit.

This interferes with accurate translation of bacterial messenger RNA and disrupts normal protein synthesis. The resulting production of abnormal proteins contributes to the antibacterial effect of the drug.

As with other aminoglycosides, its activity is primarily directed against susceptible aerobic Gram-negative bacteria.

Manufacturing and Quality

MEDIOCON INC focuses on supplying pharmaceutical active ingredients with emphasis on quality, consistency, technical documentation and reliable supply.

Isepamicin Sulfate quality evaluation may include:

  • Identification
  • Assay / potency
  • Related substances
  • Aminoglycoside-related impurities
  • Water content
  • Sulfate content
  • Residual solvents
  • Loss on drying
  • Residue on ignition
  • Heavy metals
  • Microbiological quality
  • Endotoxin testing, where applicable
  • Other product-specific analytical parameters

For aminoglycoside antibiotics, microbiological potency and impurity profiling are particularly important aspects of quality evaluation.

The exact acceptance criteria should be confirmed against the applicable approved specification and batch-specific Certificate of Analysis.

Applications

Isepamicin Sulfate may be relevant to:

  • Antibacterial pharmaceutical formulations
  • Aminoglycoside antibiotic research
  • Gram-negative bacterial research
  • Antimicrobial research
  • Pharmaceutical research and development
  • Microbiological studies

Its clinical availability and approved indications vary by country and regulatory jurisdiction.

Product Characteristics

A reliable authoritative source for the exact current commercial physical appearance specification could not be verified.

Appearance: White to off-white powder

The exact commercial appearance and physical specifications should be confirmed against the applicable MEDIOCON INC product specification and batch COA.

Packaging and Documentation

Product availability, packaging configuration, Certificate of Analysis (COA), Safety Data Sheet (SDS/MSDS), technical specifications, microbiological documentation and analytical documentation should be confirmed with MEDIOCON INC according to customer requirements and applicable regulatory standards.

Product Specifications

Product NameIsepamicin Sulfate API Manufacturer and Supplier in India
CAS Number67814-76-0
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to off-white powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to off-white powder

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Isepamicin Sulfate API Manufacturer and Supplier in India (CAS 67814-76-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Isepamicin Sulfate API Manufacturer and Supplier in India is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Isepamicin Sulfate API Manufacturer and Supplier in India

What is Isepamicin Sulfate?
Isepamicin Sulfate is an aminoglycoside antibiotic API belonging to the gentamicin-related class of antibacterial compounds.
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