Doxycycline Hyclate (CAS No.: 24390-14-5) - Broad-Spectrum Tetracycline Antibacterial for Human & Veterinary Use
As a professional supplier of pharmaceutical-grade and veterinary-grade antibacterial active ingredients, we provide high-purity Doxycycline Hyclate that strictly complies with global pharmacopoeia standards (USP, EP, BP, CP Vet). A second-generation tetracycline derivative, it exhibits enhanced potency, improved oral absorption, and a longer half-life compared to older tetracyclines (e.g., tetracycline, oxytetracycline). It is widely used in human medicine for treating bacterial and protozoal infections, and in veterinary practice for controlling infectious diseases in livestock and companion animals-making it a versatile and clinically critical antibacterial agent.
Product Basic Information
| Item | Details |
|---|---|
| Product Name | Doxycycline Hyclate (Doxycycline Hydrochloride Hemihydrate Ethanolate) |
| CAS No. | 24390-14-5 |
| Synonyms | (4S,4aS,5aR,6S,12aS)-4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride hemihydrate ethanolate; Vibramycin® (brand name for human use) |
| Molecular Formula | C₂₂H₂₄N₂O₈·HCl·0.5H₂O·0.5C₂H₅OH |
| Molecular Weight | 512.94 |
| Appearance | Yellow crystalline powder; Odorless or with a slight characteristic odor |
| Specification | - Pharmaceutical Grade: Purity ≥98.0% (HPLC); Assay (as doxycycline) ≥89.0% (anhydrous basis); Loss on drying ≤8.0%; Residue on ignition ≤0.5%; Heavy metals (Pb≤10ppm, Hg≤1ppm, Cd≤1ppm)- Veterinary Grade: Purity ≥95.0% (HPLC); Compliant with EP Vet/USP Vet; No detectable tetracycline analogs (≤0.1%) |
| Melting Point | 206-210°C (with decomposition) |
| Solubility | Freely soluble in water (≥50 g/L at 25°C); Soluble in methanol, ethanol; Slightly soluble in acetone; Insoluble in chloroform, ether |
| Storage Conditions | Store in a cool (15-25°C), dry, light-protected container; Sealed to prevent moisture absorption and photodegradation; Shelf life: 36 months for pharmaceutical grade, 24 months for veterinary grade |
Core Functions & Applications
Doxycycline Hyclate exerts its bacteriostatic effect by binding to the 30S subunit of bacterial ribosomes, inhibiting the binding of aminoacyl-tRNA to the mRNA-ribosome complex-thus blocking bacterial protein synthesis. It has a broad spectrum of activity against Gram-positive bacteria, Gram-negative bacteria, and certain protozoa (e.g., Plasmodium, Chlamydia). Its key advantages include excellent oral bioavailability (90-100%, unaffected by food), long half-life (12-22 hours, allowing once-daily dosing), and penetration into tissues (e.g., lungs, skin, prostate). It is used in both human medicine and veterinary practice:
1. Human Pharmaceutical Field
1.1 Respiratory Tract Infections
Community-Acquired Pneumonia (CAP): First-line treatment for CAP caused by Streptococcus pneumoniae (penicillin-sensitive), Mycoplasma pneumoniae, or Chlamydophila pneumoniae. Oral dose: 100 mg twice daily (or 200 mg once daily) for 7-14 days.
Chronic Bronchitis Exacerbation: Treats bacterial exacerbations caused by Haemophilus influenzae or Moraxella catarrhalis. Dose: 100 mg twice daily for 5-7 days, reducing symptom duration and preventing complications.
1.2 Skin & Soft Tissue Infections
Acne Vulgaris: Used for moderate-to-severe inflammatory acne (papules, pustules) caused by Cutibacterium acnes. Oral dose: 50-100 mg daily for 6-12 weeks, or topical formulations (2% gel) for mild cases-reducing inflammation and bacterial load.
Cellulitis & Lyme Disease: Treats cellulitis caused by Staphylococcus aureus (methicillin-sensitive) and early Lyme disease (caused by Borrelia burgdorferi). Dose: 100 mg twice daily for 14-21 days (Lyme disease) or 7-10 days (cellulitis).
1.3 Other Infections
Sexually Transmitted Infections (STIs): First-line treatment for Chlamydia trachomatis (urethritis/cervicitis) and alternative for Neisseria gonorrhoeae. Dose: 100 mg twice daily for 7 days (chlamydia) or 200 mg once daily for 7 days (gonorrhea).
Malaria Prophylaxis: Used for travelers to malaria-endemic regions (e.g., Africa, Southeast Asia). Dose: 100 mg daily, starting 1-2 days before travel and continuing 4 weeks after return-effective against Plasmodium falciparum.
2. Veterinary Field
2.1 Livestock (Cattle, Pigs, Sheep)
Respiratory Tract Infections:
Bovine respiratory disease (BRD) in feedlot cattle (caused by Mannheimia haemolytica, Pasteurella multocida): Injectable solution (20 mg/kg body weight, intramuscularly once every 48 hours for 2 doses) or oral premixes (100-200 mg/kg feed) for group prevention.
Porcine respiratory disease complex (PRDC) in pigs (caused by Actinobacillus pleuropneumoniae, Mycoplasma hyopneumoniae): Oral soluble powder (10-20 mg/kg body weight daily) for 5-7 days, reducing mortality and improving feed conversion.
Gastrointestinal Infections:
Porcine proliferative enteropathy (PPE) in growing pigs (caused by Lawsonia intracellularis): Oral dose (15 mg/kg body weight daily) for 7 days, alleviating diarrhea and intestinal lesions.
2.2 Companion Animals (Dogs, Cats)
Bacterial Infections:
Skin infections (pyoderma) in dogs (caused by Staphylococcus pseudintermedius): Oral tablets (5-10 mg/kg body weight once daily) for 14-21 days, combined with topical antiseptics.
Urinary tract infections (UTIs) in cats (caused by Escherichia coli, Enterococcus spp.): Oral dose (5 mg/kg body weight twice daily) for 7-10 days, with urine culture follow-up to confirm clearance.
Vector-Borne Diseases:
Ehrlichiosis (caused by Ehrlichia canis) in dogs: Oral dose (10 mg/kg body weight twice daily) for 28 days, eliminating the pathogen and resolving clinical signs (fever, lethargy).
Quality & Safety Assurance
Doxycycline Hyclate's dual use in humans and food-producing animals requires strict quality control, resistance management, and residue monitoring:
Raw Material & Synthesis: Produced via semi-synthetic modification of oxytetracycline (fermentation-derived) followed by purification via crystallization. Raw materials meet USP/EP standards for impurity limits (e.g., 4-epi-doxycycline ≤2.0%, a major degradation product).
Production Process:
Pharmaceutical Grade: Manufactured in GMP-certified workshops (Class C cleanroom for injectable-grade raw materials) with photoprotective equipment to prevent light-induced degradation.
Veterinary Grade: Undergoes additional testing for animal-specific impurities (e.g., heavy metals ≤5ppm) and complies with veterinary pharmacopoeia standards for residue markers.
Comprehensive Testing Protocol:
| Test Item | Method | Acceptance Criterion |
|---|---|---|
| Purity & Assay | HPLC (C18 column, 280 nm detection) | Pharmaceutical grade: ≥98.0% purity, ≥89.0% doxycycline; Veterinary grade: ≥95.0% purity |
| Related Substances | HPLC (gradient elution) | 4-epi-doxycycline ≤2.0%, total impurities ≤3.0% |
| Heavy Metals | ICP-MS (Inductively Coupled Plasma-Mass Spectrometry) | Pb≤10ppm, Hg≤1ppm, Cd≤1ppm |
| Residue Solvents | GC (headspace sampling) | Ethanol ≤500ppm, Methanol ≤300ppm |
| Sterility (Injectable Grade) | Membrane filtration method | No bacterial/fungal growth |
Safety Reminders:Human Use:
Contraindications: Hypersensitivity to tetracyclines; children <8 years (causes tooth discoloration and bone growth inhibition); pregnancy/lactation (Category D-fetal harm risk).
Adverse Effects: Gastrointestinal discomfort (nausea, diarrhea), photosensitivity (avoid excessive sun exposure), and rare hepatotoxicity (monitor in patients with liver impairment).
Veterinary Use:
Withdrawal Periods: Pigs: 5 days (meat); Cattle: 28 days (meat), 5 days (milk); Dogs/Cats: No withdrawal period (non-food animals).
Resistance Warning: Avoid overuse (e.g., continuous feed supplementation) to prevent emergence of doxycycline-resistant strains (e.g., Salmonella spp., E. coli).
Cooperation & Contact
We supply Doxycycline Hyclate in multiple grades and formulations to meet diverse needs:
Pharmaceutical Grade: Raw powder for oral tablets, capsules, and injectables (1kg-100kg per order).
Veterinary Grade: Raw powder for premixes, soluble powders, and injectables (10kg-500kg per order; monthly production capacity of 800kg).
Value-added services include:
Providing DMF (Drug Master File) and CEP (Certificate of Suitability) for pharmaceutical-grade products to support registration in the EU, US, and Asia.
Customized formulation development (e.g., taste-masked oral powders for companion animals, stable injectable solutions for livestock).
Technical guidance on resistance management (veterinary clients) and adverse reaction monitoring (pharmaceutical clients).
If you are a pharmaceutical manufacturer, veterinary drug enterprise, or companion animal health company, please contact us for detailed cooperation:
Contact Information:
Email: sales@huarongpharma.com
Phone/WhatsApp: +86 13751168070
We adhere to the principles of "quality compliance, safety priority, and long-term win-win" and look forward to partnering with global healthcare and animal health enterprises!
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