Appearance & Form:
Yellow crystalline powder, hygroscopic upon prolonged exposure to ambient humidity exceeding 60% RH.
Solubility Profile:
Freely soluble in water; sparingly soluble in ethanol (96%). Solutions exhibit acidic reaction kinetics and degrade rapidly in alkaline environments.
Particle Size Distribution (PSD):
Standard grade D90 < 75 micrometers; micronized grade (D90 < 50 micrometers) available for injectable suspension lines to prevent needle clogging and sedimentation.
Thermal Behavior:
Melts with decomposition at approx. 180°C; store below 25°C protected from light.
Compliance with current pharmacopeial monographs ensures direct integration into regulated manufacturing lines and streamlined dossier submissions.
|
Parameter |
Specification Standard (USP/BP) |
Typical Batch Analytical Result |
|
Description |
Yellow, crystalline powder; odorless; bitter taste |
Conforms |
|
Identification (A, B, C) |
Positive reactions per USP monograph |
Positive |
|
Assay (anhydrous basis) |
89.0% - 102.0% (or 95.0% - 102.0% dried basis) |
99.4% |
|
Specific Optical Rotation |
-188° to -200° (1% in 0.01M HCl) |
-192° |
|
pH (1% w/v aqueous solution) |
2.3 - 2.9 |
2.6 |
|
Loss on Drying |
<= 2.0% |
0.8% |
|
Sulfated Ash / Residue on Ignition |
<= 0.5% |
0.12% |
|
Heavy Metals |
<= 50 ppm |
< 10 ppm |
Formulation engineers integrate this API across multiple commercial veterinary dosage forms:
Injectable Solutions:
Long-acting and standard intramuscular formulations for cattle, swine, and sheep targeting systemic and respiratory infections.
Oral Powders & Soluble Granules:
Drinking water administration for poultry flocks to manage airsacculitis and chronic respiratory disease (CRD).
Feed Premixes:
Therapeutic and metaphylactic inclusion in swine and poultry feed production under strict veterinary feed directive (VFD) controls.
Intra-uterine Infusions:
Boluses and suspensions for bovine metritis management.
Pharmaceutical Manufacturing Relevance
Dissolution Kinetics:
Controlled crystal habit ensures rapid dissolution rates in aqueous vehicles, minimizing phase separation in multi-dose suspension vials.
Excipient Compatibility:
Compatible with standard chelating agents (e.g., magnesium chloride hexahydrate) and stabilizing antioxidants (e.g., sodium formaldehyde sulfoxylate) utilized in liquid injectable matrices.
Powder Flowability:
Free-flowing characteristics prevent bridging and arching in automated industrial hopper feeds during dry-blend premix processing.
Grade Identification:
Pharma Grade, cGMP compliant.
Pharmacopeia Conformance:
Fully conforms to USP, BP, and Ph. Eur. monographs.
Impurities Profile:
Controlled in strict accordance with ICH Q3A/Q3B guidelines for related substances and degradation products (4-epianhydrotetracycline <= 0.5%, anhydrotetracycline <= 0.5%).
Residual Solvents:
Tested via Headspace Gas Chromatography (GC-HS) confirming conformance with ICH Q3C limits for Class 2 and Class 3 solvents.
Batch Testing Protocol:
Every production lot undergoes independent analytical release testing via HPLC, FTIR, and atomic absorption spectroscopy.
Reference Standards:
Analytical assays calibrated directly against primary USP/EP reference standards.
Data Integrity Architecture:
Laboratory testing managed via 21 CFR Part 11 compliant Chromatography Data Systems (CDS), guaranteeing unalterable audit trails.
Retention Sample Protocol:
A 5-year retention sample archive is maintained for every commercial batch in climate-controlled stability chambers (25°C / 60% RH and 40°C / 75% RH).
Complete documentation packages are available under Confidentiality Agreement (CDA) or upon verified commercial inquiry:
COA (Certificate of Analysis):
Details full batch-specific chemical assay, impurity breakdown, microbiological load tests, and physical characteristics.
SDS (Safety Data Sheet):
GHS-compliant documentation outlining handling precautions, necessary PPE, and industrial spill response procedures.
TDS (Technical Data Sheet):
Summarizes physical-chemical parameters, storage constraints, and recommended reconstitution limits.
Lead Time:
Ex-stock items: Dispatch within 5 - 7 business days upon order verification.
Production orders: 3 - 4 weeks for manufacturing schedule integration.
MOQ (Minimum Order Quantity):
100 kg (standard commercial export drum configuration).
Sample Policy:
Analytical samples (50 g - 500 g) provided for laboratory validation and method transfer upon receipt of corporate credentials and active courier account details.
Bulk Supply Capacity:
Annual manufacturing output exceeding 500 metric tons, supporting structured quarterly blanket orders and multi-port container shipments (FCL/LCL).
Primary Packaging:
Double-layer food/pharma-grade low-density polyethylene (LDPE) bags, heat-sealed under nitrogen purge to prevent moisture migration and photo-oxidation.
Secondary Packaging:
Fiber drums fitted with tamper-evident security seals (Standard Net Weight: 25 kg/drum). Dimensions: 38 x 51 cm. Palletized and stretch-wrapped for international container freight.
Storage Guidelines:
Store in a tight, light-resistant container below 25°C in a dry, well-ventilated warehouse environment. Shelf life: 3 years from manufacturing date when unopened and stored as directed.
Custom Particle Size Distribution: Tailored micronization available (D90 down to 10 micrometers) for specialized suspension or micro-encapsulation delivery systems.
Custom Packaging Configurations: Alternative net-weight increments (5 kg, 10 kg, 50 kg fiber drums or foil bags) engineered to match plant automated charging requirements.
Private Labeling: Neutral unbranded labeling or custom client-specified shipping marks available for contract manufacturing organizations (CMOs).
Submit your required annual volume, destination port, and target delivery schedule to receive a commercial quotation including FOB/CIF pricing and current batch COA samples.
As one of the most professional veterinary pharmaceuticals manufacturers and suppliers in China, we're featured by quality products and good service. Please feel free to buy high-grade veterinary pharmaceuticals from our factory. For price consultation, contact us.
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