Description

Tebipenem Pivoxil Impurity 1 is a specified impurity of the oral carbapenem antibiotic, Tebipenem Pivoxil. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method development, quality control, and regulatory compliance. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in the synthesis, purification, and quality assurance of Tebipenem Pivoxil API and its formulations.

Application

• Primary use as a certified reference standard (CRS) for the identification and quantification of impurities in Tebipenem Pivoxil Active Pharmaceutical Ingredient (API).
• Essential for analytical method development and validation (HPLC, UPLC, LC-MS) to ensure specificity and accuracy.
• Critical component in stability studies and degradation pathway profiling of Tebipenem Pivoxil drug products.
• Used in pharmaceutical quality control (QC) laboratories to monitor impurity levels against ICH guidelines.
• Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity data for drug master files.
• Valuable for research and development of synthetic routes and purification processes for Tebipenem Pivoxil.

Basic Information

Product Name	Tebipenem Pivoxil Impurity 1
CAS No.	1595319-80-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tebipenem Pivoxil Related Compound 1; Tebipenem Pivoxil EP Impurity 1; Tebipenem Pivoxil USP Impurity 1; Tebipenem Pivoxil Impurity A; Tebipenem Pivoxil Specified Impurity; (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; Tebipenem Pivoxil Degradant; Tebipenem Impurity 1
EINECS	Contact for details

Quality Control

Our Tebipenem Pivoxil Impurity 1 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC purity determination and structural confirmation (e.g., by NMR, MS), to ensure it meets the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and impurity profile is provided with every shipment, supporting compliance with ICH Q3A(R2) and Q3B(R2) guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (MS)	Consistent with molecular structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%

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