Doxycycline Hyclate is a pharmaceutical active pharmaceutical ingredient (API) belonging to the tetracycline class of broad-spectrum antibiotics. It is used in the manufacture of pharmaceutical formulations for the treatment of a variety of bacterial infections.
Doxycycline is a semisynthetic tetracycline antibiotic with broad-spectrum antibacterial activity. It works primarily by inhibiting bacterial protein synthesis through binding to the 30S ribosomal subunit of susceptible bacteria.
Doxycycline is available in pharmaceutical formulations in different forms, including Doxycycline Hyclate. Doxycycline Hyclate is widely used as an API for the manufacture of oral pharmaceutical products such as capsules, tablets and other dosage forms.
Doxycycline inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. This prevents the attachment of aminoacyl-tRNA to the bacterial ribosome and inhibits the addition of amino acids to the growing peptide chain.
Doxycycline API is used in pharmaceutical formulations for a range of susceptible bacterial infections, including applications involving:
The exact approved indications depend on the specific finished dosage form and applicable regulatory labeling.
Doxycycline Hyclate is generally described as a yellow to light-yellow crystalline powder. It is hygroscopic and should be stored under appropriate controlled conditions to maintain its pharmaceutical quality.
Doxycycline Hyclate API intended for pharmaceutical manufacturing should be produced and tested according to applicable pharmacopoeial and GMP requirements. Quality evaluation may include identification, assay, related substances, water content, residual solvents, elemental impurities and other applicable quality attributes.
Doxycycline Hyclate is an established pharmaceutical antibiotic API used by formulation manufacturers worldwide. Pharmaceutical companies can evaluate Doxycycline API based on pharmacopoeial compliance, analytical documentation, regulatory requirements and batch-specific Certificate of Analysis.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 95.0% – 102.0% on anhydrous basis |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 3.0 |
| Individual Impurity | NMT 1.0% |
| Total Impurities | NMT 2.0% |
| Water Content | NMT 1.0% |
| Melting Point | 168°C – 172°C |