Description

Thiotepa Impurity 1 is a specified impurity and degradation product of the antineoplastic agent Thiotepa. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control. It is primarily used by analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and biotechnology industries to ensure the purity, safety, and efficacy of Thiotepa drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Thiotepa active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, validating, and verifying HPLC, UPLC, and GC methods to monitor impurity profiles in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed to track the formation of degradation products in Thiotepa formulations under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Quality Control & Batch Release: A critical component in the quality control laboratory for routine testing, ensuring each batch of Thiotepa meets stringent purity specifications before release.
• Regulatory Submissions: Provides necessary data on impurity identity and levels for inclusion in regulatory filings such as Drug Master Files (DMFs), Common Technical Documents (CTD), and applications to the FDA, EMA, and other global health authorities.
• Process Chemistry Research: Used to study and optimize synthesis and purification processes to minimize the formation of this specific impurity.

Basic Information

Product Name	Thiotepa Impurity 1
CAS No.	90877-51-3
Molecular Formula	C6H12N3PS
Molecular Weight	189.22 g/mol
Synonyms	Aziridine, 1,1',1''-phosphinothioylidynetris-; Tris(1-aziridinyl)phosphine sulfide; TEPA Sulfide; N,N',N''-Tri-1-aziridinylphosphinothioic amide; Phosphorothioic triamide, N,N',N''-tri-1-aziridinyl-; Thio-TEPA Impurity A; Thiotepa Related Compound A
EINECS	Contact for details

Quality Control

Every batch of Thiotepa Impurity 1 is manufactured and analyzed under strict quality systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC-DAD/ELSD, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results, including chromatographic purity, water content, and residual solvents, is provided with each shipment to support your regulatory and research needs.

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 in accordance with safe laboratory practices for potentially hazardous chemicals.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Any individual impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 1.0%

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