Sulfadimethoxine is a long-acting sulfonamide antimicrobial agent that competitively inhibits bacterial dihydropteroate synthase, disrupting folic acid synthesis and inhibiting the proliferation of susceptible pathogens. It is supplied as a pharmaceutical-grade active ingredient for veterinary pharmaceutical manufacturing.
Key Specifications
|
Parameter |
Technical Specification |
Test Method / Reference |
|
Assay (Dried Basis) |
99.0% to 101.0% |
Titration / HPLC |
|
Appearance |
White or almost white crystalline powder |
Visual Inspection |
|
Melting Range |
197°C to 200°C, with decomposition |
Capillary Method |
|
Loss on Drying |
Maximum 0.5% |
105°C, 3 Hours |
|
Residue on Ignition |
Maximum 0.1% |
Pharmacopeial Procedure |
Chemical & Pharmacological Profile
CAS Registry Number: 122-11-2
Molecular Formula: C12H14N4O4S
Molecular Weight: 310.33 g/mol
Mechanism of Action: Competitive inhibition of bacterial folate synthesis by interfering with the utilization of para-aminobenzoic acid, providing broad-spectrum bacteriostatic activity against susceptible Gram-positive and Gram-negative bacteria.
Product-Specific Technical Focus
Particle Size Distribution: Micronized grades are available with a D90 value below 15 micrometers to support improved suspension characteristics and dissolution performance in liquid formulations.
Residual Solvents: Residual solvents are controlled in accordance with applicable ICH Q3C requirements. Production processes can utilize ethanol and purified water, with controls in place to minimize residual solvent levels.
Polymorphic Form: The crystalline form can be characterized by X-ray powder diffraction to support consistent solid-state properties during storage and downstream formulation.
Veterinary Formulation Applications
Swine Premixes: Used as an active ingredient in veterinary feed formulations for the management of susceptible bacterial infections in swine.
Poultry Soluble Powders: Suitable for veterinary formulations administered through drinking water systems where permitted by applicable regulations.
Cattle Formulations: Can be incorporated into veterinary dosage forms intended for systemic treatment of susceptible bacterial infections in cattle, subject to the requirements of the finished product.
Impurity Control
Related Substances: Individual specified impurities are controlled according to applicable product specifications and pharmacopeial requirements.
Total Impurities: Total related substances are controlled within established quality specifications to ensure consistent pharmaceutical-grade purity.
Heavy Metals / Elemental Impurities: Elemental impurities are controlled in accordance with applicable pharmaceutical quality requirements and may be determined using ICP-MS or other validated analytical methods.
Quality Control Framework
Batch Testing: Each production batch undergoes analytical testing before release, including appropriate methods such as HPLC, UV-Vis spectrophotometry, and moisture determination.
Method Validation: Analytical methods are validated or verified according to applicable pharmaceutical quality standards to ensure accuracy, precision, specificity, and reproducibility.
Reference Standards: Qualified pharmacopeial or appropriately characterized reference standards are used for analytical calibration and quality control.
Documentation & Regulatory Support
Certificate of Analysis: A comprehensive CoA is available for each commercial batch, including actual test results for applicable quality parameters.
Regulatory Documentation: Technical and quality documentation can be provided to support customer regulatory assessment and veterinary pharmaceutical registration, subject to applicable confidentiality and documentation requirements.
Traceability: Batch-level traceability is maintained throughout raw material sourcing, manufacturing, quality testing, packaging, and shipment.
Storage Conditions
Environment: Store in tightly sealed containers and protect from direct sunlight, excessive humidity, and contamination.
Temperature: Store under controlled room-temperature conditions according to the product specification.
Shelf Life: The applicable retest period or shelf life is established based on stability data and specified storage conditions.
Packaging & Logistics
Primary Packaging: Double-layer pharmaceutical-grade polyethylene bags, securely sealed to protect the material from moisture and contamination.
Secondary Packaging: Fiber drums or other qualified shipping containers, commonly supplied in 25 kg net configurations.
Transportation: Transport under suitable conditions that protect the product from moisture, excessive heat, direct sunlight, and physical damage.
Frequently Asked Questions
Q: What pharmacopeia standards does this material conform to?
A: The applicable specification can be established according to relevant USP, EP, or other recognized pharmacopeial requirements, depending on the customer's target market and regulatory requirements.
Q: Is analytical method validation data available for audit?
A: Relevant analytical method validation or verification documentation can be provided for qualified customers, subject to confidentiality requirements.
Q: What is the standard minimum order quantity for commercial batches?
A: Commercial supply is commonly available in 25 kg packaging configurations. Pilot-scale samples can be discussed according to project requirements.
Q: How are particle size specifications verified?
A: Particle size distribution can be measured using laser diffraction or another validated particle-size analysis method according to the agreed product specification.
Q: Can customized specifications be discussed?
A: Yes. Particle size, packaging configuration, documentation requirements, and other applicable quality parameters can be discussed according to the customer's formulation and regulatory requirements.
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