Description

Meropenem Impurity Diastereomer 1 is a defined stereoisomeric impurity used as a critical reference standard in the analytical profiling of the broad-spectrum carbapenem antibiotic, Meropenem. This high-purity compound is essential for pharmaceutical manufacturers and quality control laboratories to ensure the safety, efficacy, and regulatory compliance of the final drug product. It is primarily used by researchers and analysts in the pharmaceutical industry for method development, validation, and routine impurity monitoring.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of diastereomeric impurities in Meropenem Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Critical for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to separate and analyze stereoisomeric impurities.
• Quality Control & Batch Release Testing: Used in routine QC testing to monitor impurity levels against ICH Q3A(R2) and Q3B(R2) guidelines, ensuring batch-to-batch consistency.
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to track the formation of specific degradation products.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., with FDA, EMA) to establish impurity profiles and justify specification limits.
• Research & Development: Supports R&D efforts in understanding the degradation pathways and stereochemistry of Meropenem and related β-lactam antibiotics.

Basic Information

Product Name	Meropenem Impurity Diastereomer 1
CAS No.	96035-27-7
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 1; Meropenem Related Compound Diastereomer 1; Stereoisomer of Meropenem; (1'R,5S,6S)-Meropenem; Meropenem EP Impurity D (Diastereomer); Meropenem USP Related Compound
EINECS	Contact for details

Quality Control

Every batch of Meropenem Impurity Diastereomer 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and strength testing to ensure compliance with pharmacopeial standards and customer specifications. A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions or in a desiccator to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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