Description

Tebipenem Pivoxil Impurity P9 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for the quality control and regulatory compliance of the antibiotic Tebipenem Pivoxil, ensuring the safety and efficacy of the final pharmaceutical product. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality assurance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Tebipenem Pivoxil Impurity P9 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used in HPLC, LC-MS, and other chromatographic methods to establish impurity profiles and ensure method specificity and accuracy.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to monitor impurity levels and ensure batches comply with ICH guidelines and regulatory specifications.
• Stability Studies: Employed in forced degradation and long-term stability studies of Tebipenem Pivoxil to track the formation and behavior of this specific impurity.
• Regulatory Documentation: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Research & Development: Supports impurity profiling, synthesis pathway optimization, and degradation mechanism studies during the drug development process.

Basic Information

Product Name	Tebipenem Pivoxil Impurity P9
CAS No.	1595319-82-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tebipenem Pivoxil Related Compound P9; Tebipenem Pivoxil Impurity 9; Tebipenem Pivoxil EP Impurity P9; Tebipenem Pivoxil USP Impurity P9; (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 P9; Tebipenem Pivoxil Degradation Product P9
EINECS	Contact for details

Quality Control

Our Tebipenem Pivoxil Impurity P9 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and traceability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, LC-MS, and NMR. We support compliance with ICH Q3A, Q3B, and relevant pharmacopeial standards (USP, EP). Certificates of Analysis (COA) are available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or Certificate of Analysis. The material should be kept in a dry environment and handled under inert conditions if specified.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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