Description

Meropenem Impurity Diastereomer 2 is a defined stereoisomeric impurity used as a critical reference standard in the pharmaceutical quality control process. This compound is essential for the accurate identification, quantification, and monitoring of related substances during the development and manufacturing of the broad-spectrum carbapenem antibiotic, Meropenem. It is primarily required by pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and contract research organizations (CROs) to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and system suitability testing in chromatographic analyses (HPLC, UPLC).
• Quality Control & Assurance: Used for the precise quantification of diastereomeric impurities in Meropenem Active Pharmaceutical Ingredient (API) and finished drug products to meet pharmacopeial specifications (USP, EP, JP).
• Regulatory Compliance & Filing: Critical for preparing regulatory submission documents (e.g., for FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Stability Studies: Employed as a marker to track impurity formation and degradation pathways in Meropenem under various stress conditions (thermal, photolytic, hydrolytic).
• Process Chemistry & Optimization: Used by API manufacturers to monitor and optimize synthesis and purification steps, minimizing the formation of this specific stereoisomeric impurity.
• Research & Development: Facilitates studies on the pharmacokinetics, toxicity, and biological impact of Meropenem impurities.

Basic Information

Item	Detail
Product Name	Meropenem Impurity Diastereomer 2
CAS No.	96035-15-3
Molecular Formula	C17H25N3O5S
Molecular Weight	383.46 g/mol
Synonyms	(4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)pyrrolidin-3-yl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid; Meropenem Diastereomer 2; Meropenem Related Compound Diastereomer 2; Stereoisomer of Meropenem; Meropenem EP Impurity D; Meropenem USP Related Compound; (1R,5S,6S)-2-[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-3-carboxylic acid
EINECS	Contact for details

Quality Control

Every batch of Meropenem Impurity Diastereomer 2 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, NMR, and MS to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the needs of cGMP-compliant environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. This product is light-sensitive (store away from light).

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0% w/w
Residue on Ignition	≤ 0.5%

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