General Information

Lincomycin Impurities and Lincomycin 

For evaluating the purity and safety of Lincomycin, an active pharmaceutical ingredient, Daicel Pharma offers a customized synthesis of Lincomycin impurity standards. These impurity standards include crucial compounds such as Lincomycin 2-Phosphate, Lincomycin EP Impurity E Hydrochloride, Lincomycin Impurity A, Lincomycin Impurity C, and Lincomycin-2,4 -phosphate. Additionally, Daicel Pharma provides worldwide delivery options for Lincomycin impurity standards.

Lincomycin [CAS: 154-21-2], derived from the bacteria Streptomyces Lincolnensis, is an antibiotic belonging to the lincosamide class. It exhibits efficacy against anaerobic bacteria and gram-positive bacteria. This antibiotic is from a variant of Streptomyces lincolnensis known as var. lincolnensis. It treats infections caused by staphylococci, streptococci, and Bacteroides fragilis bacteria.

Lincomycin: Use and Commercial Availability  

Lincocin is the brand name under which the drug, Lincomycin is available. It treats bacterial infections caused by susceptible streptococci, pneumococci, and staphylococci strains. The antibiotic is for patients allergic to penicillin or when penicillin is considered inappropriate. It is important to note that Lincomycin is for infections strongly suspected to be caused by bacteria susceptible to the drug, as with all antibacterial agents.

Lincomycin Structure and Mechanism of Action

The chemical name of Lincomycin is Methyl 6,8-dideoxy-6-[[[(2S,4R)-1-methyl-4-propyl-2-pyrrolidinyl]carbonyl]amino]-1-thio-D-erythro-α-D-galacto-octopyranoside. Its chemical formula is C₁₈H₃₄N₂O₆S, and its molecular weight is approximately 406.5 g/mol.

Lincomycin inhibits protein synthesis in susceptible organisms and prevents peptide bond formation.

Lincomycin Impurities and Synthesis

Impurities in Lincomycin refer to any substances in the Lincomycin drug product that are not in the desired active pharmaceutical ingredient (API). They may arise from various sources like manufacturing¹, raw materials, or drug degradation over time. Common impurities found in Lincomycin include related compounds, residual solvents, and degradation products. The presence and levels of these impurities are carefully monitored and controlled during the manufacturing process to ensure the safety, efficacy, and quality of the Lincomycin drug product. Regulatory authorities have established guidelines and limits for impurity levels to ensure the purity of the drug and minimize potential adverse effects.

Daicel Pharma strictly adheres to cGMP standards and operates an analytical facility for preparing Lincomycin impurity standards, which include Lincomycin 2-Phosphate, Lincomycin EP Impurity E Hydrochloride, Lincomycin impurity A, Lincomycin Impurity C, and Lincomycin-2,4 -phosphate. Our Lincomycin impurity standards have a detailed Certificate of Analysis (CoA) that provides a comprehensive characterization report. This report includes data obtained through techniques,1H NMR, 13C NMR, IR, MASS, and HPLC purity analysis². Upon request, we give additional data like 13C-DEPT. Moreover, we can synthesize unknown Lincomycin impurity standards and degradation products. Each delivery has a comprehensive characterization report.