Tigecycline is a glycylcycline antibacterial and a member of the tetracycline class of antimicrobial agents. It is a structurally modified tetracycline derivative developed to provide activity against a broad range of clinically important bacteria, including organisms with certain tetracycline-resistance mechanisms.
Tigecycline has the molecular formula C₂₉H₃₉N₅O₈, a molecular weight of 585.65 g/mol, and CAS Number 220620-09-7. It is recognized as an official USP substance and is identified by USP through infrared spectroscopy and chromatographic retention characteristics.
Tigecycline is a semisynthetic glycylcycline derived from the tetracycline structural family. Its molecular structure contains multiple amino, hydroxyl and amide functionalities characteristic of this antibacterial class.
The API is particularly important for pharmaceutical formulations intended for parenteral administration and is subject to stringent controls for assay, organic impurities, water content, optical rotation and microbiological quality.
Product Name: Tigecycline
CAS Number: 220620-09-7
Molecular Formula: C₂₉H₃₉N₅O₈
Molecular Weight: 585.65 g/mol
Chemical Class: Glycylcycline antibacterial
Pharmacological Class: Tetracycline-class antibacterial
Development Code: GAR-936
The defined stereochemical configuration of Tigecycline is specified in the USP chemical name as (4S,4aS,5aR,12aS).
Tigecycline inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. This interferes with the incorporation of amino acids into bacterial proteins and ultimately inhibits bacterial growth.
As a glycylcycline, Tigecycline was developed to retain antibacterial activity against organisms expressing several common tetracycline resistance mechanisms.
Tigecycline API is used in the development and manufacture of pharmaceutical formulations for antibacterial therapy.
Its pharmaceutical applications include formulations designed for the treatment of susceptible bacterial infections. Tigecycline is administered intravenously in its approved medicinal-product applications, and the corresponding drug substance requires appropriate controls for purity, assay, water, impurities and microbiological quality.
FDA describes Tigecycline as a tetracycline-class antibacterial for intravenous infusion.
Tigecycline is covered by a USP monograph with defined analytical requirements. The USP assay uses liquid chromatography with UV detection at 248 nm and specifies an assay range of 97.0–102.0% on an anhydrous and solvent-free basis.
The USP organic-impurity procedure controls several identified and specified impurities, including Tigecycline open ring, Tigecycline 12-oxo-11-hydroxy, Tigecycline related compound B, Tigecycline epimer, Tigecycline quinone analog, Minocycline and Tigecycline tricyclic analog. The USP limit for total impurities is NMT 2.2%.
Additional quality controls include:
Swapnroop Drugs and Pharmaceuticals provides quality-focused pharmaceutical API manufacturing and documentation solutions for specialized active pharmaceutical ingredients.
Tigecycline requires careful control because it is sensitive to degradation and the USP monograph specifies moisture-controlled handling during quantitative analysis. The current USP requirements provide defined acceptance criteria for assay, impurities, water, optical rotation and other quality attributes.
Swapnroop's Tigecycline API offering can be supported with appropriate analytical documentation and batch-specific quality information according to the applicable specification.
USP specifies that Tigecycline should be preserved in airtight, light-resistant containers under nitrogen and stored refrigerated. Solutions used for analytical testing are also protected from light because Tigecycline can undergo degradation.
Suitable packaging and controlled storage help protect the API from moisture, light and other environmental factors that may affect its quality.
Tigecycline API documentation may include:
Tigecycline is a specialized antibacterial API requiring controlled analytical testing and appropriate storage conditions. Swapnroop focuses on specification-driven pharmaceutical API quality, analytical documentation and batch-level quality control.
Tigecycline API from Swapnroop is positioned for pharmaceutical customers requiring a quality-focused source of this USP-recognized glycylcycline antibacterial drug substance.
| Parameter | Specification |
|---|---|
| Appearance | white to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 97.0–102.0% |
| Residue on Ignition | NMT 0.1% |
| pH (1% Solution) | 7.7–8.2 |
| Total Impurities | NMT 2.2% |
| Water Content | NMT 2.5% |