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High Purity Gentamicin Sulfate

High Purity Gentamicin Sulfate

  • $215

    1-49 Others

  • $210

    50-499 Others

  • $200

    ≥500 Others

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Product Attributes

Product Description

Gentamicin Sulfate Powder API

Gentamicin Sulfate Powder is a pharmaceutical-grade aminoglycoside antibiotic active ingredient supplied for veterinary and pharmaceutical manufacturing applications. As a water-soluble sulfate salt of gentamicin, it is widely used by qualified manufacturers producing regulated injectable, topical, and other dosage forms requiring controlled potency, purity, and analytical documentation.

Product Overview

Gentamicin Sulfate is the sulfate salt form of gentamicin, a mixture of closely related aminoglycoside compounds produced through microbial fermentation. The main components are gentamicin C1, C1a, and C2, which contribute to the activity profile of the API.

As a pharmaceutical active ingredient, Gentamicin Sulfate requires strict quality control due to its complex composition. Professional buyers typically evaluate potency, component profile, microbial quality, endotoxin control, impurity limits, and batch documentation before supplier qualification.

Gentamicin Sulfate Powder is commonly supplied as a white to off-white powder with good water solubility, making it suitable for pharmaceutical formulation processes where aqueous compatibility is required.

Gentamicin Sulfate Specifications

Item Specification
Product Name Gentamicin Sulfate Powder
Product Category Pharmaceutical Active Ingredient / Aminoglycoside Antibiotic
Salt Form Gentamicin sulfate
CAS Number 1405-41-0
Molecular Formula C21H43N5O7 · xH2SO4
Molecular Weight Approximately 575.67 g/mol (gentamicin sulfate complex)
Appearance White to off-white powder
Assay Pharmaceutical-grade potency according to applicable specifications
Identification Conforms to gentamicin sulfate reference standard identification requirements
Standard Test Method HPLC or microbiological potency assay methods
Composition Gentamicin C1, C1a, and C2 components controlled according to specifications
Water Content Controlled according to applicable pharmaceutical requirements
Related Substances Controlled according to API specifications
Microbial Quality Controlled according to pharmaceutical quality standards
Endotoxin Controlled according to applicable pharmaceutical requirements
Particle Size Fine powder; customized according to formulation requirements
Shelf Life Typically 24 months under recommended storage conditions
Storage Store tightly sealed in a cool, dry place protected from moisture and direct light
Packaging Pharmaceutical-grade foil bags and fiber drums; customized packaging available

Gentamicin Sulfate Selection Guide: Component Profile and Quality Evaluation

The most important sourcing factor for Gentamicin Sulfate is understanding that it is not a single pure molecule but a defined mixture of related gentamicin components. Buyers should evaluate component composition, potency testing method, microbial quality controls, and documentation rather than focusing only on total assay.

Evaluation Factor Why It Matters Buyer Consideration
Gentamicin Component Profile Determines consistency of the active complex Review C1, C1a, and C2 composition data
Potency Testing Confirms antibacterial activity level Evaluate HPLC and/or microbiological assay methods
Microbial Quality Control Important for pharmaceutical applications Review microbial limits and endotoxin-related data
Documentation Package Supports API qualification Assess COA, TDS, SDS, and analytical records

Why Component Control Matters for Gentamicin Sulfate

Gentamicin Sulfate differs from many small-molecule APIs because it consists of multiple related active components. Maintaining a consistent component profile helps manufacturers achieve reliable formulation performance and predictable quality between production batches.

Typical Applications

  • Veterinary pharmaceutical formulations
  • Human pharmaceutical manufacturing applications
  • Injectable dosage form development
  • Topical pharmaceutical formulations
  • Pharmaceutical quality-control testing

Quality Control

Gentamicin Sulfate Powder requires comprehensive pharmaceutical quality evaluation before release. Typical quality control procedures include:

  • Identity confirmation
  • Potency assay testing
  • Gentamicin component analysis
  • HPLC testing
  • Microbial limit testing
  • Endotoxin testing
  • Water content determination
  • Batch consistency evaluation

COA, TDS, SDS, and technical documentation can be provided for pharmaceutical procurement review and supplier qualification procedures.

Why Choose This Gentamicin Sulfate Powder?

  • Pharmaceutical-grade aminoglycoside API specification
  • Controlled component profile and potency testing
  • Suitable for injectable and pharmaceutical formulation applications
  • Reliable batch quality management
  • Professional analytical documentation support
  • Stable bulk supply capability
  • Controlled packaging and storage procedures
  • Technical support for pharmaceutical qualification

Packaging and Storage

Gentamicin Sulfate Powder is commonly supplied in sealed pharmaceutical-grade packaging designed to protect the material from moisture, contamination, and environmental exposure.

The product should be stored in tightly sealed containers under cool and dry conditions. Protection from humidity, heat, and direct light helps maintain API quality during storage.

OEM and Pharmaceutical Supply Support

Gentamicin Sulfate can support pharmaceutical projects requiring API sourcing, documentation preparation, specification review, and bulk ingredient supply. Support may include packaging customization, technical documentation, and supply coordination according to project requirements.

Procurement FAQs

Is Gentamicin Sulfate a single compound?

Gentamicin Sulfate is a sulfate salt complex containing closely related gentamicin components, mainly C1, C1a, and C2. Quality evaluation therefore includes component profile analysis in addition to overall potency testing.

Why is potency testing important for Gentamicin Sulfate?

Because gentamicin is a complex antibiotic mixture, potency testing helps confirm the activity level and consistency of each batch. Reliable analytical methods support pharmaceutical quality evaluation.

What documents should buyers request for Gentamicin Sulfate API?

Buyers should review the product specification sheet, batch COA, analytical reports, TDS, SDS, and quality documentation. Important points include potency, component profile, microbial quality, endotoxin control, and storage requirements.

How should Gentamicin Sulfate Powder be stored?

Gentamicin Sulfate should be stored in sealed packaging under cool and dry conditions, protected from moisture, heat, and direct light. Storage conditions should follow the product specification and technical documentation.

Conclusion

Gentamicin Sulfate Powder is a specialized pharmaceutical active ingredient requiring accurate component control, potency verification, and reliable quality documentation. With controlled specifications and professional supply support, it provides a dependable raw material option for pharmaceutical and veterinary formulation development. Contact us today to request samples, a COA, technical documents, and a wholesale quotation for Gentamicin Sulfate Powder.

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