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CAS 33286-22-5 officially identifies Doxycycline Hyclate (Doxycycline hydrochloride hemiethanolate hemihydrate), represented empirically by the stoichiometric formula (C22H24N2O8·HCl)2 · C2H6O · H2O, yielding a relative molecular mass of 1025.87 g/mol. As a second-generation, broad-spectrum tetracycline derivative developed via stereo-specific catalytic hydrogenation of oxytetracycline or metacycline, it displays pronounced lipophilic partition characteristics that facilitate superior cellular membrane permeability compared to first-generation analogs.
| Analytical Parameter | USP Compendial Standard | EP / BP Compendial Standard | Factory In-House Release Criteria |
|---|---|---|---|
| Identity Testing (IR & HPLC) | Conforms to Reference Standard | Conforms to Reference Standard | Dual-Match Fingerprint Confirmed |
| Assay (Anhydrous, Ethanol-Free) | 900 µg to 1020 µg of Doxycycline/mg | 95.0% - 102.0% | 98.5% - 101.5% Target Purity |
| pH Determination (10 mg/mL in H2O) | 2.0 to 3.0 | 2.0 to 3.0 | 2.2 to 2.8 Optimized |
| Specific Optical Rotation | -110° to -120° | -105° to -120° | -112° to -118° |
| Water Content (Karl Fischer) | 1.4% to 2.8% | 1.5% to 3.0% | 1.8% to 2.4% Monitored |
| Ethanol Content (GC-FID) | 4.3% to 6.0% | 4.3% to 6.0% | 4.6% to 5.4% Controlled |
| Related Impurity A (4-Epidoxycycline) | ≤ 0.5% | ≤ 0.5% | ≤ 0.2% Ultra-Pure Cut |
| Related Impurity B (Metacycline) | ≤ 2.0% | ≤ 1.5% | ≤ 0.5% Minimal Residuals |
The hemiethanolate hemihydrate solvate architecture guarantees enhanced thermodynamic stability over doxycycline monohydrate, suppressing polymorphic transitions and maintaining crystal dissolution kinetics in tableting and compounding formulations.
Under elevated thermal or basic conditions, doxycycline reversible epimerization yields 4-epidoxycycline. Precision synthesis with low-temperature crystallization matrices reduces total diastereomeric degradation below strict 0.2% thresholds.
CAS 33286-22-5 dissolves readily in water (approx. 50 mg/mL) and dilute mineral acids, producing acidic solutions critical for veterinary soluble powder formulations and parental preparation reconstitution systems.
The global demand for Doxycycline Hyclate (CAS 33286-22-5) spans three interconnected industries: high-volume livestock/veterinary prophylactic management, clinical human healthcare therapeutics, and advanced biomedical gene switch systems. Procuring from verified primary manufacturers eliminates middleman markups while insulating downstream producers against regulatory recalls and raw material delays.
Global poultry and swine livestock integrators require ton-scale, free-flowing crystalline powder with rapid aqueous dispersibility. In livestock, CAS 33286-22-5 controls porcine respiratory disease complexes (PRDC) caused by Actinobacillus pleuropneumoniae and avian mycoplasmosis with superior tissue absorption.
Sustained demand across oral capsules, delayed-release tablets, and sterile lyophilized intravenous solutions for treating Lyme disease, community-acquired pneumonia, chlamydia trachomatis infections, and non-antibiotic sub-antimicrobial dose (SDD) periodontitis therapies.
Biomedical researchers and genetic engineers utilize ultra-pure CAS 33286-22-5 as an inducer effector for Tet-On / Tet-Off transcriptional activation. Sub-toxic concentrations modulate recombinant protein expression, shRNA transcription, and cellular reprogramming with tight dose-response fidelity.
Modern API synthesis requires moving past fragmented legacy batch vessels into interconnected Industry 4.0 manufacturing campuses. Chinese chemical manufacturing infrastructure leads the global market by integrating upstream fermentation, catalytic flow chemistry, automated crystalline crystallization, and closed-loop green solvent recovery.
Our production facilities link primary Streptomyces rimosus microbial fermentation directly with chemical modification lines. Transforming crude oxytetracycline into metacycline intermediates on-site removes inter-factory transport friction, limits oxidation exposure, and shields buyers from raw-intermediate price shocks.
Replacing high-volume batch autoclave hydrogenation with continuous flow microreactors dramatically enhances mass and thermal transfer. High-pressure stereoselective catalytic reduction over noble metal catalyst (Pd/C or Rh/C) achieves >98% alpha-epimer stereospecific yield, suppressing toxic beta-isomers.
Real-time near-infrared (NIR) and focused beam reflectance measurement (FBRM) monitor crystallization solvate nucleation in real time. Automated solvent addition rates control crystalline habit and grain dimensions, ensuring consistent powder bulk density and flowability for automatic tablet presses.
Operating under strict environmental standards, our facility utilizes closed-loop condensation units capturing >96% of organic ethanol and hydrochloric acid vapors. Thermal reclamation systems lower net carbon emissions per metric ton, ensuring multi-year audit compliance and zero unannounced environmental shutdowns.
Formulating with Doxycycline Hyclate requires precise handling of moisture sensitivity, light vulnerability, and chelation with polyvalent metal cations (Mg2+, Al3+, Ca2+, Fe2+). Our technical specialists provide full formulation dossiers to streamline client product development.
Our micronized and granulated grades deliver balanced bulk tap density (0.60–0.75 g/mL) and minimal electrostatic retention. Combining with microcrystalline cellulose and magnesium stearate alternatives avoids metal chelation, preventing tablet degradation and dissolution slowdowns.
Engineered for high-volume automated drinking water dispensing systems, our veterinary powder grade dissolves instantly in cold ambient water without clumping, forming stable aqueous solutions without precipitating mineral chelates in hard-water livestock lines.
For parenteral formulations, our sterile lyophilized-grade powder complies with rigorous bacterial endotoxin thresholds (< 0.5 EU/mg) and particulate matter standards (USP <788>), ensuring clear reconstitution in sterile water or saline solutions.
Critical compliance, chemical stability, and international logistics questions answered by our technical documentation and export compliance group.
Doxycycline Hyclate (CAS 33286-22-5) is a hydrochloric acid salt containing ethanol and water of crystallization (hydrochloride hemiethanolate hemihydrate), whereas Doxycycline Monohydrate (CAS 17086-28-1) is the base molecule with one water molecule and no acid component. Hyclate has significantly higher water solubility (approx. 50 mg/mL vs <1 mg/mL for monohydrate) and is the preferred active substance for soluble powders, syrups, and quick-dissolving tablets, though its acidic nature requires careful formulation to minimize gastrointestinal irritation.
Every commercial batch includes a comprehensive Certificate of Analysis (COA) containing batch number, HPLC chromatogram with impurity profiling, GC-FID residual solvent quantification (specifically ethanol and residual organic solvents), Karl Fischer water titration, and heavy metal assays. For qualified pharmaceutical customers, we supply complete Open-Part Drug Master Files (DMF), EDQM Certificate of Suitability (CEP) dossiers, stability test summaries (accelerated and long-term ICH Q1A guidelines), and BSE/TSE-free declarations.
CAS 33286-22-5 is hygroscopic and sensitive to light and temperatures exceeding 30°C. Material is packed in double-layer pharmaceutical-grade low-density polyethylene (LDPE) food-contact liners with vacuum desiccant packs inside light-blocking, hermetically sealed aluminum foil bags, enclosed in fiberboard drums. Recommended warehouse storage is in a cool, dry place between 2°C and 8°C or ambient climate-controlled conditions (<25°C, RH <60%). Air freight logistics utilize temperature-monitored, moisture-sealed containers.
Yes. Standard crystallization yields crystalline granules with a D90 of approximately 150–250 µm, which promotes powder flow during tableting. Upon request, we provide fluid-energy jet milling to supply ultra-fine micronized grades (D90 < 20 µm or D50 < 5 µm) intended for inhalation suspensions or aerosol applications, complete with Laser Diffraction particle size distribution reports (Malvern Mastersizer 3000).
We maintain strategic safety inventory in temperature-controlled bonded warehouses for standard grades, enabling 48-hour air courier dispatch (via DHL, FedEx, or air charter forwarding). Bulk container orders (FCL/LCL ocean shipping) typically ship within 7–14 business days from production confirmation. We provide door-to-door DDP (Delivered Duty Paid) shipping services including export declarations, customs clearance, and import tariff clearance across major international ports.
Connect directly with our chemical engineering and export regulatory team. Request updated sample Certificates of Analysis (COA), audit dossiers, and custom spot or annual contract quotes tailored to your production schedule.
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