Description

Tigecycline Impurity 2 CAS NO 1422262-97-2 is a high-purity chemical reference standard critical for the analytical profiling and quality control of the antibiotic Tigecycline. This impurity is essential for pharmaceutical manufacturers and research laboratories to ensure drug safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily used in the development, validation, and routine testing of Tigecycline active pharmaceutical ingredients (APIs) and finished drug products.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development and validation in HPLC and LC-MS analysis of Tigecycline.
• Quality Control & Assurance (QC/QA): Used for the identification, qualification, and quantification of this specific impurity in Tigecycline API batches to meet pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed as a marker to monitor the formation of degradation products in Tigecycline formulations under various stress conditions.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity profiles and characterization data.
• Research & Development (R&D): Used in synthetic chemistry research to study the degradation pathways and metabolism of Tigecycline.
• Contract Research Organizations (CROs) & Testing Labs: Provides a reliable benchmark for third-party testing and analysis services for pharmaceutical clients.

Basic Information

Product Name	Tigecycline Impurity 2
CAS No.	1422262-97-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tigecycline Related Compound 2; Tigecycline Impurity B; (4S,4aS,5aR,12aS)-9-(2-(tert-Butylamino)acetamido)-4,7-bis(dimethylamino)-3,10,12,12a-tetrahydroxy-1,11-dioxo-1,4,4a,5,5a,6,11,12a-octahydrotetracene-2-carboxamide; Tigecycline EP Impurity B; Tigecycline USP Impurity 2
EINECS	Contact for details

Quality Control

Our Tigecycline Impurity 2 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, assay, and identification. Production is aligned with cGMP principles to ensure traceability, consistency, and reliability for critical quality control applications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive); ensure the container is sealed tightly after each use to prevent exposure to atmospheric moisture, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0% w/w

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