Description

Tebipenem Pivoxil Impurity P6 is a high-purity chemical reference standard used in the analytical profiling of the antibiotic drug substance Tebipenem Pivoxil. This impurity is critical for pharmaceutical research and development, enabling precise identification, quantification, and control during the manufacturing process. It is essential for quality assurance laboratories, regulatory compliance teams, and analytical chemists working in the pharmaceutical and contract research organization (CRO) sectors to ensure drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Tebipenem Pivoxil API and finished dosage forms.
• Analytical Research: Used in HPLC, UPLC, and LC-MS studies for the identification and quantification of related substances in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity profiles and characterization data.
• Stability Studies: Employed to monitor the formation of this specific impurity under various stress conditions (e.g., heat, humidity, light) as part of drug stability testing programs.
• Process Chemistry & Optimization: Aids chemists in understanding and minimizing the formation of this impurity during the synthesis and purification stages of Tebipenem Pivoxil manufacturing.
• Contract Laboratory Testing: A key component for CROs and testing laboratories offering impurity identification and control services to pharmaceutical clients.

Basic Information

Product Name	Tebipenem Pivoxil Impurity P6
CAS No.	1665289-91-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tebipenem Pivoxil Related Compound P6; Tebipenem Pivoxil Impurity 6; Tebipenem Pivoxil EP Impurity P6; Tebipenem Pivoxil USP Impurity P6; Tebipenem Pivoxil Related Substance P6; (4R,5S,6S)-3-[[(3S,5S)-5-[(Dimethylamino)carbonyl]-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid Pivaloyloxymethyl Ester Impurity P6; Tebipenem Pivoxil P6
EINECS	Contact for details

Quality Control

Every batch of Tebipenem Pivoxil Impurity P6 is manufactured and handled under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced chromatographic and spectroscopic techniques to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA), detailing batch-specific results for identity, assay, purity, and related substances, is provided and available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
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.