General Information

Demeclocycline Impurities and Demeclocycline

Daicel Pharma synthesizes Demeclocycline impurities of exceptional quality, such as 4-Epidemeclocycline, 4-Epidemethyltetracycline, Demeclocycline Impurity F, Demeclocycline Impurity G, and Demethyltetracycline Impurity-A. These impurities are crucial to assess the purity, reliability, and safety of Demeclocycline, an active pharmaceutical ingredient. Besides, Daicel Pharma provides custom synthesis of Demeclocycline impurities to meet clients’ demands for delivery worldwide.

Demeclocycline [CAS: 127-33-3], a semi-synthetic tetracycline derived from Streptococcus aureofaciens, is an antibiotic and arginine vasopressin inhibitor. It is a broad-spectrum naphthacene antibiotic. Compared to tetracycline, it has a slower excretion rate, allowing it to maintain blood levels for longer durations. Demeclocycline treats hyponatremia and the syndrome of inappropriate secretion of antidiuretic hormone (SIADH).

Demeclocycline: Use and Commercial Availability 

Demeclocycline, available under the tradename Declomycin, is a tetracycline antibiotic that exhibits broad-spectrum activity against gram-positive and gram-negative bacteria. It targets the underlying pathophysiology of SIADH.

Demeclocycline Structure and Mechanism of Action

The chemical name of Demeclocycline is (4S,4aS,5aS,6S,12aS)-7-Chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-1,11-dioxo-2-naphthacenecarboxamide. Its chemical formula is C₂₁H₂₁ClN₂O_8, and its molecular weight is approximately 464.9 g/mol.

The mechanism of action of Demeclocycline is not known.

Demeclocycline Impurities and Synthesis

Impurities in Demeclocycline can form through degradation of the active pharmaceutical ingredient, interaction with excipients, or contaminants in raw materials. They can affect the quality and efficacy of the drug product. Analytical methods such as chromatography and spectroscopy help analyze and identify Demeclocycline impurities. Their control measures involve establishing impurity level limits, following good manufacturing practices, and regular testing during the manufacturing process. Rigorous quality control and monitoring ensure that Demeclocycline batches meet regulatory requirements and maintain high levels of purity, ensuring the effectiveness and safety of the medication.

Daicel Pharma offers a Certificate of Analysis (CoA) for Demeclocycline impurity standards, such as 4-Epidemeclocycline, 4-Epidemethyltetracycline, Demeclocycline Impurity F, Demeclocycline Impurity G, and Demethyltetracycline Impurity-A, generated from an analytical facility compliant with cGMP standards. The CoA includes a comprehensive characterization report comprising data from techniques like 1H NMR, 13C NMR, IR, MASS, and HPLC purity^1,2. Furthermore, on request, we give additional data like 13C-DEPT and CHN. Daicel Pharma can synthesize unknown Demeclocycline impurities or degradation products. A complete characterization report accompanies every delivery.