Plazomicin Sulfate API is a next-generation aminoglycoside antibacterial active pharmaceutical ingredient developed to address bacterial infections caused by resistant Gram-negative pathogens. Plazomicin is structurally derived from the aminoglycoside class and was designed to retain antibacterial activity against many organisms that have developed resistance to older aminoglycosides.
Plazomicin Sulfate is identified by CAS Number 1380078-95-4. PubChem reports the sulfate form with molecular formula C₂₅H₅₀N₆O₁₄S and molecular weight 690.8 g/mol. The free active moiety, plazomicin, has CAS Number 1154757-24-0, molecular formula C₂₅H₄₈N₆O₁₀, and molecular weight 592.7 g/mol.
Plazomicin belongs to the aminoglycoside antibacterial class. It was developed as a semisynthetic aminoglycoside designed to overcome several clinically important aminoglycoside-resistance mechanisms. Its antibacterial activity is associated with binding to the bacterial 30S ribosomal subunit, resulting in inhibition of bacterial protein synthesis.
Plazomicin sulfate was approved by the U.S. FDA in 2018 for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Enterobacteriaceae. The approved medicinal product was marketed as Zemdri and administered by intravenous infusion.
Plazomicin is a structurally modified aminoglycoside containing multiple amino and hydroxyl functionalities. The sulfate salt is the pharmaceutical form associated with the approved drug substance.
The FDA review identifies the drug substance as plazomicin sulfate and describes plazomicin free base as C₂₅H₄₈N₆O₁₀ with a molecular weight of 592.69 g/mol. The sulfate drug substance is reported in the FDA review as a variable sulfate form because the sulfate counterion composition can be represented according to the salt stoichiometry.
For chemical database purposes, PubChem identifies Plazomicin Sulfate as CAS 1380078-95-4, formula C₂₅H₅₀N₆O₁₄S, and molecular weight 690.8 g/mol.
Plazomicin Sulfate is an antibacterial API associated with the treatment of serious infections caused by susceptible Gram-negative bacteria. Its principal approved clinical application has been complicated urinary tract infections, including pyelonephritis.
Plazomicin was developed to provide antibacterial activity against organisms carrying resistance mechanisms that can reduce the activity of conventional aminoglycosides. Its mechanism involves interaction with bacterial ribosomes and inhibition of protein synthesis.
Plazomicin Sulfate is a complex aminoglycoside API requiring comprehensive analytical characterization. FDA's review of the drug substance and finished product identifies quality controls including identity, assay, degradants, pH, particulates, endotoxins and sterility for the drug product.
For API manufacturing, appropriate analytical controls can include:
Because a universally applicable public pharmacopoeial monograph with numerical API release limits was not verified, numerical values should not be invented for the CMS release specification.
As a Plazomicin API Manufacturer in India, we focus on quality-controlled manufacturing and analytical evaluation of Plazomicin Sulfate for pharmaceutical applications.
Plazomicin is a specialized aminoglycoside API requiring careful control of chemical identity, purity, related substances, sulfate composition and other critical quality attributes. Appropriate analytical methods and batch-specific quality documentation are therefore important for pharmaceutical API manufacturing.
Plazomicin Sulfate can be supported with relevant technical and quality documentation according to applicable customer, regulatory and product-specific requirements.
Plazomicin Sulfate should be packed in suitable pharmaceutical-grade containers that protect the material from moisture, contamination and other environmental factors.
The approved drug product is supplied as a sterile aqueous solution for intravenous infusion. FDA's review describes a 10 mL Type I clear glass vial for the finished product. This packaging information should not be interpreted as the universal packaging requirement for bulk API.
For API storage, the final condition should follow validated stability data and the approved API specification.
Typical documentation for Plazomicin Sulfate API may include:
Plazomicin Sulfate is a specialized next-generation aminoglycoside API with pharmaceutical relevance in the treatment of serious Gram-negative bacterial infections. Its defined chemical identity, established antibacterial mechanism and pharmaceutical development history make robust quality control particularly important.
For organizations seeking a Plazomicin API Manufacturer in India, controlled manufacturing, analytical characterization and appropriate pharmaceutical documentation can support formulation development and API requirements.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |