Oxytetracycline Hydrochloride is a broad-spectrum tetracycline antibiotic produced via fermentation and chemical synthesis of Streptomyces rimosus, supplied as a crystalline powder for veterinary pharmaceutical manufacturing. It binds to the 30S ribosomal subunit, halting peptide chain elongation and inhibiting bacterial protein synthesis across a wide range of gram-positive and gram-negative pathogens.
Technical Specifications
|
Parameter |
Specification Standard |
Test / Evaluation Method |
|
Assay (Potency) |
835.0 mcg/mg to 927.0 mcg/mg (anhydrous basis) |
HPLC per USP/EP Monograph |
|
Specific Optical Rotation |
-190 degrees to -210 degrees (dried basis) |
Polarimetry at 20 degrees C |
|
pH Value |
2.3 to 2.9 (1% aqueous solution) |
Potentiometric determination |
|
Loss on Drying |
NMT 2.0% |
Oven drying at 105 degrees C for 3 hours |
|
Sulfated Ash |
NMT 0.5% |
Ignition at 600 degrees C |
|
Particle Size (Oral) |
Standard granule distribution |
Laser diffraction analysis |
|
Particle Size (Injectable) |
Micronized grade (D90 under 10 um) |
Laser diffraction analysis |
|
Bulk Density |
0.45 g/cm3 to 0.60 g/cm3 |
Tapped density tester |
Chemical Profile
Molecular Data: Chemical Formula C22H24N2O9 . HCl, Molecular Weight 496.90 g/mol, CAS Number 2058-46-0.
Solubility Profile: Freely soluble in water (1 part in 2 parts) at 20 degrees C; slightly soluble in ethanol; practically insoluble in chloroform and ether.
Stability & Flow: Optimized bulk density and low angle of repose (under 32 degrees) ensuring uniform gravity flow during high-speed direct compression and capsule filling.
Formulation Applications
Oral Soluble Powders: Formulated into drinking water treatments for swine and poultry to manage herd-wide respiratory and enteric infections.
Injectable Solutions: Micronized active grades compatible with standard co-solvents (propylene glycol, pyrrolidone derivatives) for long-acting intramuscular suspensions.
Intra-Mammary Ointments: Utilized in bovine udder infusion formulations for treating clinical and subclinical mastitis during lactation or dry periods.
Impurity Profile & Limits
4-Epitetracycline Hydrochloride: Controlled below 0.5% to prevent reduced antimicrobial potency.
Anhydrotetracycline & Epianhydrotetracycline: Maintained below 0.5% via thermal and acid exposure controls during synthesis.
Individual Unspecified Impurity: Limited to NMT 0.1% via gradient HPLC quantification.
Elemental Impurities: Lead (under 0.5 ppm), Cadmium (under 0.2 ppm), Arsenic (under 1.0 ppm), Mercury (under 0.1 ppm) per ICH Q3D.
Quality Assurance
Batch Testing: Full-item release testing covering assay, impurity profile, pH, moisture, and microbial limits per commercial lot.
Microbial Limits: TAMC under 1000 CFU/g, TYMC under 100 CFU/g, absence of Escherichia coli and Salmonella in 10 g.
Reference Traceability: Analytical testing calibrated directly against official primary pharmacopoeial reference standards (USP/EPCRS).
Regulatory Documentation
Technical Dossiers: Certificate of Analysis (CoA) and Safety Data Sheet (SDS) supplied with every manufacturing lot.
Regulatory Packages: Drug Master File (DMF) availability status and stability study packages (40 degrees C / 75% RH accelerated, 25 degrees C / 60% RH long-term) provided upon request.
Facility Compliance: Produced under certified Good Manufacturing Practice (GMP) conditions with validated water and HVAC systems.
Storage & Handling
Environmental Controls: Store in a tightly closed container protected from light at controlled room temperature between 15 degrees C and 25 degrees C.
Shelf Life: 36 months from the date of manufacture in original unopened packaging.
Handling Precautions: Avoid direct dust inhalation and prolonged skin contact; utilize appropriate personal protective equipment (PPE) during facility operations.
Packaging & Logistics
Primary Packaging: Sealed double low-density polyethylene (LDPE) inner liners tied securely.
Secondary Packaging: Heavy-duty fiber drums containing moisture-absorbent desiccant packets between liners.
Net Weight: 25 kg per drum, protecting the hygroscopic active ingredient from ambient humidity fluctuations.
Shipping Compliance: Classified as non-hazardous material for road, rail, air, and ocean freight transport.
Frequently Asked Questions
Q: What pharmacopoeia standards does this material meet?
A: The active pharmaceutical ingredient is manufactured and tested in strict accordance with USP and EP monograph specifications.
Q: Are particle size customisations available for suspension injection grades?
A: Yes, micronized specifications (D90 under 10 um or D90 under 75 um) are available to meet specific suspension stability requirements.
Q: What is the standard minimum order quantity (MOQ) for evaluation?
A: Laboratory sample sizes range from 100g to 1kg, with commercial batch MOQs established starting from standard 25kg drum units.
Q: What documentation accompanies each commercial shipment?
A: Each cargo dispatches with an original Certificate of Analysis (CoA), packing list, commercial invoice, and batch-specific compliance statement.
Q: How is moisture protection maintained during international ocean freight?
A: The dual-layer LDPE liner system combined with sealed fiber drums and desiccant inserts prevents moisture permeation throughout transit.
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