Description

Zidovudine Impurity 13 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Zidovudine (AZT). This compound is critical for ensuring the purity, safety, and efficacy of antiviral drug formulations by serving as a reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of antiretroviral medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Zidovudine (AZT) API batches.
• Method Development and Validation: Essential for developing, optimizing, and validating analytical methods such as HPLC and UPLC in quality control laboratories.
• Stability Studies: Employed to monitor the formation of degradation products in Zidovudine formulations under various stress conditions.
• Regulatory Compliance and Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Pharmacopoeial Testing: Used to ensure compliance with stringent purity specifications outlined in pharmacopoeias such as USP, EP, and BP.
• Research and Development: Aids in synthetic route optimization and impurity profiling during the R&D phase of generic and innovative drug development.

Basic Information

Product Name	Zidovudine Impurity 13
CAS No.	123606-70-2
Molecular Formula	C10H13N5O4
Molecular Weight	267.24 g/mol
Synonyms	AZT Impurity 13; 3'-Azido-3'-deoxy-5'-O-(4-methoxybenzoyl)thymidine; 1-[(2R,4S,5S)-4-Azido-5-[(4-methoxybenzoyl)oxy]methyl]tetrahydrofuran-2-yl]-5-methylpyrimidine-2,4(1H,3H)-dione; 3'-N3-5'-O-(p-Methoxybenzoyl)-3'-deoxythymidine; Zidovudine 5'-O-(4-Methoxybenzoate) Impurity; Thymidine, 3'-azido-3'-deoxy-, 5'-(4-methoxybenzoate)
EINECS	Contact for details

Quality Control

Every batch of Zidovudine Impurity 13 is manufactured and controlled under a strict quality management system. Our products undergo rigorous identity, purity, and assay testing using advanced analytical techniques to ensure compliance with industry standards for reference materials. Certificates of Analysis (COA) containing detailed results from HPLC, NMR, and MS are provided with each shipment to support your regulatory and quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. Handle and store under an inert atmosphere if the material is found to be easily oxidized.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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