Tetracycline Hydrochloride

Tetracycline hydrochloride is a broad-spectrum polyketide antimicrobial agent produced via Streptomyces fermentation, supplied as a high-purity crystalline powder tailored for veterinary pharmaceutical manufacturing. It reversibly binds to the bacterial 30S ribosomal subunit, halting peptide elongation and inhibiting protein synthesis across a wide spectrum of Gram-positive pathogens, Gram-negative pathogens, mycoplasmas, and chlamydiae.

Molecular Formula: C22H24N2O8·HCl

Molecular Weight: 480.90 g/mol

Solubility: Freely soluble in water; slightly soluble in ethanol (96%); practically insoluble in chloroform and ether.

Mechanism of Action: Binds to the bacterial ribosome and interferes with aminoacyl-tRNA attachment, thereby inhibiting bacterial protein synthesis.

Particle Size Distribution: Pulverization can be controlled to achieve a target D90 below 75 micrometers, supporting uniform dispersion and dissolution during formulation.

Thermal Stability: Thermal behavior can be evaluated by differential scanning calorimetry to support appropriate processing conditions during veterinary feed manufacturing.

Powder Flowability: Powder flow characteristics can be monitored using Carr's Index and Hausner Ratio to support reliable material handling and automated feeding operations.

Poultry Soluble Powders: Used in veterinary formulations administered through drinking water systems for susceptible bacterial infections.

Swine Feed Premixes: Incorporated into medicated feed formulations where tetracycline hydrochloride is approved for the intended veterinary application.

Calf Oral Suspensions: Used as an active pharmaceutical ingredient in oral veterinary formulations for livestock.

Aquaculture Formulations: Applied in controlled veterinary and aquaculture formulations where tetracycline use is permitted for the target species and application.
 

4-Epitetracycline Hydrochloride: Controlled as a related substance to maintain product purity and stability.

Anhydrotetracycline Hydrochloride: Monitored as a degradation-related impurity during manufacturing and storage.

4-Epianhydrotetracycline Hydrochloride: Controlled through process monitoring and chromatographic testing.

Heavy Metals: Controlled according to the applicable product specification and regulatory requirements, with ICP-MS available where required.

Chromatographic Purity: Assessed using HPLC with appropriate chromatographic conditions to monitor related substances and degradation products.

Residual Solvents: GC testing can be performed to verify residual solvents comply with applicable regulatory requirements.

Microbial Limits: Microbiological quality is controlled according to the applicable pharmacopeial or customer specification.

Batch Consistency: Critical quality attributes such as assay, related substances, pH, moisture, and physical properties are monitored across production batches.

Certificate of Analysis: A batch-specific Certificate of Analysis is provided with actual test results for applicable quality parameters.

Regulatory Dossiers: Regulatory documentation and supporting technical files may be available according to customer and market requirements.

Compliance Statements: TSE/BSE-related declarations and other applicable compliance statements can be provided upon request.

Analytical Support: Analytical methods, specifications, and relevant validation or method-transfer documentation can be discussed with qualified customers.

Temperature Control: Store tightly closed in a cool, dry place protected from direct light. Recommended storage temperature is 15°C to 25°C unless otherwise specified by the approved product specification.

Humidity Protection: Keep the container tightly sealed and protected from excessive moisture.

Shelf Life: Up to 36 months from the date of manufacture when stored in the original unopened packaging under recommended conditions, subject to the approved product specification.

Primary Packaging: Double-layer pharmaceutical-grade polyethylene bags, securely sealed to protect the material from moisture and contamination.

Secondary Packaging: Rigid fiber drums or other agreed commercial packaging with appropriate moisture protection.

Standard Unit Size: Common commercial packaging is available in 25 kg net weight drums, subject to customer requirements.

Transport Conditions: Shipped using appropriate international freight conditions with protection from excessive heat, moisture, direct sunlight, and contamination.

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