Neomycin Sulfate

Neomycin Sulfate:

Neomycin Sulfate is a broad-spectrum aminoglycoside active pharmaceutical ingredient manufactured for commercial pharmaceutical and veterinary formulation. It functions by binding to the bacterial 30S ribosomal subunit to inhibit protein synthesis, targeting gram-negative and select gram-positive pathogens. Produced as a hygroscopic crystalline powder, it complies with established pharmacopeial standards for secondary processing and drug manufacturing.

 

Product Specifications:

Pharmacopeial Compliance	USP / BP / EP
Potency (Dried Basis)	>= 600 ug/mg calculated as Neomycin base
Identification	Positive for Neomycin and Sulfate via chromatographic and chemical tests
pH (10% aqueous solution)	5.0 - 7.5
Loss on Drying	<= 8.0%
Residue on Ignition	<= 1.0%
Specific Optical Rotation	+53 deg to +59 deg
Heavy Metals	<= 20 ppm

 

Chemical & Physical Properties:

CAS Number: 1405-10-3

Molecular Formula: C23H46N6O13 · 3H2SO4

Molecular Weight: 908.88 g/mol (Sulfate salt)

Solubility: Freely soluble in water; practically insoluble in absolute ethanol, acetone, chloroform, and ether

Appearance: White or yellowish-white, odorless or practically odorless powder

 

Applications:

Topical Formulations: Incorporated into dermatological creams, ointments, and lotions for cutaneous bacterial infections and wound care.

Ophthalmic & Otic Preparations: Utilized in sterile eye drops and ear drops for superficial ocular and external auditory canal infections.

Veterinary Formulations: Compounded into oral powders, premixes, and boluses for enteric infection control in livestock and poultry.

Aseptic Irrigation: Used in localized wash formulations under strictly controlled manufacturing environments.

 

Pharmaceutical Manufacturing Relevance:

Excipient Compatibility: Compatible with standard petrolatum bases, emulsifying waxes, and aqueous cream systems within regulated storage thresholds.

Combination Formulations: Frequently co-formulated alongside Polymyxin B Sulfate and Bacitracin Zinc to broaden spectrum coverage against mixed flora.

Compounding Parameters: Formulators account for moisture absorption rates during weighing and blending to preserve precise active ingredient concentrations.

 

Grade & Quality Requirements:

USP Grade: Conforms to United States Pharmacopeia monograph requirements for purity, impurities, and assay limits.

EP Grade: Meets European Pharmacopoeia specifications, ensuring controlled endotoxin levels and degradation impurities.

Regulatory Support: Supported by Drug Master File (DMF) reference availability and CEP documentation parameters upon request for regulatory submissions.

 

Quality Control:

Analytical Verification: Every batch is tested via High-Performance Liquid Chromatography (HPLC) for potency validation and impurity quantification.

Microbial Limit Testing: Evaluated for total aerobic count, yeast, mold, and verified absence of specified indicator pathogens including Escherichia coli and Pseudomonas aeruginosa.

Batch Traceability: Maintained via computerized tracking from raw fermentation inputs through downstream isolation to final packaging.

 

Technical Documents:

COA

Batch-specific Certificate of Analysis supplied with every commercial delivery, detailing assay value, moisture level, pH, and analytical impurity profiles.

SDS

Safety Data Sheet outlining hazard identification, exposure controls, personal protective equipment requirements, and emergency containment protocols.

TDS

Technical Data Sheet summarizing physical parameters, storage specifications, and regulatory compliance standards.

 

Packaging & Storage:

Packaging Configuration: Double low-density polyethylene bags heat-sealed inside a fiber drum or aluminum barrier liners for small volumes.

Net Weight: 25 kg/drum standard industrial format. Custom packaging configurations available upon agreement.

Storage Conditions: Store in airtight containers in a cool, dry, well-ventilated area protected from light and moisture. Recommended storage at 2 deg C to 8 deg C for long-term storage or below 25 deg C for active handling.

Shelf Life: 36 months from the manufacturing date in original sealed containers.

 

Supply & Procurement:

MOQ

25 kg (one standard commercial drum). Evaluation quantities available for laboratory testing.

Sample

100 g analytical sample provided for method validation and HPLC verification. Courier and handling terms apply.

Lead Time

Ex-stock batches ship within 3 to 5 business days. Scheduled production runs require 3 to 4 weeks depending on volume and manufacturing queues.

Bulk Supply

Supported through annual frame agreements and multi-tonne call-off delivery schedules.

 

OEM / Custom Specification:

Custom Packaging: Private labeling, specific net weight per container, and tamper-evident seal designs available for contract manufacturers.

Impurity Profiling: Customized analytical screening available to align with specific regional pharmacopeial requirements or internal quality frameworks.

 

 

Request a Quote

To receive a formal commercial proposal, please provide your specifications:
Required annual volume or batch quantity
Destination port (Incoterms: FOB / CIF / EXW)
Preferred pharmacopeial standard (USP or EP)
Target delivery schedule or call-off frequency
 

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