Description

Zidovudine USP Impurity G is a specified impurity of the antiretroviral drug Zidovudine (AZT), used as a certified reference standard for analytical purposes. This compound is critical for pharmaceutical quality control, enabling the accurate identification, quantification, and monitoring of impurities during drug substance and drug product development and manufacturing. It is primarily required by analytical laboratories, quality assurance departments, and regulatory affairs teams within the global pharmaceutical and biotechnology sectors to ensure product safety, efficacy, and compliance with stringent pharmacopeial standards like USP and ICH guidelines.

Application

• Pharmaceutical Reference Standard: Serves as a primary chemical reference material for the qualitative and quantitative analysis of Zidovudine (AZT) and its related substances.
• Method Development and Validation: Used in developing and validating stability-indicating analytical methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control Testing: Essential for routine batch release testing of Zidovudine Active Pharmaceutical Ingredient (API) and finished dosage forms to ensure impurity levels are within specified limits.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track the formation of this specific impurity over time and under various stress conditions.
• Regulatory Compliance and Filing: Provides necessary data for regulatory submissions (e.g., ANDA, NDA) to agencies like the US FDA, EMA, and others, demonstrating thorough impurity characterization.
• Research and Development: Used in R&D laboratories to study the degradation pathways and chemistry of Zidovudine, aiding in process optimization and formulation development.

Basic Information

Product Name	Zidovudine USP Impurity G
CAS No.	148665-49-0
Molecular Formula	C10H13N5O4
Molecular Weight	267.24 g/mol
Synonyms	AZT Impurity G; 3'-Azido-2',3'-dideoxy-5'-O-(phenylcarbonyl)thymidine; 5'-O-Benzoyl-3'-azido-3'-deoxythymidine; 3'-Azido-3'-deoxy-5'-O-benzoylthymidine; Thymidine, 3'-azido-2',3'-dideoxy-5'-(phenylcarbonate); Zidovudine Related Compound G; ZDV Impurity G
EINECS	Contact for details

Quality Control

Every batch of Zidovudine USP Impurity G is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, NMR, and Mass Spectrometry to ensure it meets the exacting standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant pharmacopeial guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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