Description

Tigecycline Impurity 24 is a high-purity chemical reference standard used in pharmaceutical research, development, and quality control. This compound is critical for ensuring the safety and efficacy of the antibiotic Tigecycline by enabling the accurate identification, quantification, and monitoring of this specific impurity during the manufacturing process. It is an essential material for analytical laboratories, pharmaceutical manufacturers, and regulatory bodies focused on API impurity profiling and method validation.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Tigecycline.
• Analytical Method Development & Validation: Used to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity detection.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing in API and finished drug product manufacturing.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., FDA, EMA) by providing definitive impurity characterization data for drug master files (DMFs).
• Stability Studies: Employed to track the formation and levels of this impurity under various stress and long-term storage conditions.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to synthesize purer batches of the active pharmaceutical ingredient (API).

Basic Information

Product Name	Tigecycline Impurity 24
CAS No.	866602-58-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	(9-tert-Butylglycylamido-6-demethyl-6-deoxytetracycline) Impurity 24; Tigecycline Related Compound 24; Tygacil Impurity 24; GAR-936 Impurity 24; (4S,4aS,5aR,12aS)-9-(2-(tert-Butylamino)acetamido)-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide (possible structural descriptor).
EINECS	Contact for details

Quality Control

Every batch of Tigecycline Impurity 24 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept in a desiccated environment to prevent moisture absorption, which could affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time matches reference standard
Identification (MS)	Mass spectrum conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any single unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.