General Information

Doxycycline Impurities and Doxycycline 

Daicel Pharma synthesizes high-quality Doxycycline impurities, Doxycycline Impurity D, 4-Epidoxycycline, and 6-Epidoxycycline, which are crucial in the analysis of the quality, stability, and biological safety of the active pharmaceutical ingredient Doxycycline. Moreover, Daicel Pharma offers custom synthesis of Doxycycline impurities and delivers them globally.

Doxycycline [CAS: 564-25-0] is an antibiotic with broad-spectrum bacteriostatic properties, derived synthetically from a naturally occurring tetracycline known as oxytetracycline, produced by bacteria of the Streptomyces species. Doxycycline belongs to the tetracycline class of antibiotics.

Doxycycline: Use and Commercial Availability

Doxycycline is effective against a wide range of bacteria, including both gram-positive and gram-negative, aerobic and anaerobic bacteria, mycoplasma, and spirochetes. It has demonstrated particular effectiveness against several periodontal pathogens such as Porphyromonas gingivalis, Bacteroides forsythus, Prevotella intermedia, Actinobacillus actinomycetemcomitans, Campylobacter rectus, and Fusobacterium nucleatum. Doxycycline is available under several brand names, including Acticlate, Doryx, Doxy, Monodox, Oracea, Vibramycin, Xyrosa, and Zenavod, among others.

Doxycycline Structure and Mechanism of Action

The chemical name of Doxycycline is (4S,4aR,5S,5aR,6R,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. Its chemical formula is C₂₂H₂₄N₂O₈ and its molecular weight is approximately 444.4 g/mol.

Doxycycline is an antimicrobial drug, that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit.

Doxycycline Impurities and Synthesis

Doxycycline can contain impurities that may form during the synthesis¹, storage, or transportation. These impurities include epimeric impurities, which form during the synthesis of Doxycycline. They can impact the drug’s stability, efficacy, and safety, and their levels must be monitored and controlled during manufacturing, storage, and transportation.

Daicel offers a Certificate of Analysis (CoA) from a cGMP-compliant analytical facility for Doxycycline impurity standards, Doxycycline Impurity D, 4-Epidoxycycline, and 6-Epidoxycycline. The CoA includes complete characterization data, such as 1H NMR, 13C NMR, IR, MASS, and HPLC purity². We also provide 13C-DEPT and CHN on request. We give a complete characterization report on delivery. Daicel has the technology and expertise to prepare any unknown Doxycycline impurity or degradation product.