Description

Meropenem Trihydrate Impurity B is a specified, structurally characterized impurity used in the analytical profiling and quality control of the broad-spectrum carbapenem antibiotic, Meropenem. This high-purity reference standard is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance. It is primarily utilized in research and development, method validation, and as a system suitability standard in chromatographic assays for the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Meropenem Trihydrate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating HPLC or UPLC methods to monitor impurity profiles.
• Quality Control & Batch Release Testing: Used in routine QC laboratories to confirm that Meropenem batches meet stringent pharmacopeial (e.g., USP, EP) impurity limits.
• Stability Studies: Employed to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of Meropenem formulations.
• Regulatory Submissions: Provides necessary data and chromatographic markers for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity control.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Meropenem under various stress conditions.

Basic Information

Product Name	Meropenem Trihydrate Impurity B
CAS No.	166901-45-7
Molecular Formula	C17H25N3O5S • 3H2O
Molecular Weight	437.48 g/mol (Anhydrous basis: 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 Trihydrate; Meropenem Impurity B; Meropenem Related Compound B; (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 Trihydrate
EINECS	Contact for details

Quality Control

Every batch of Meropenem Trihydrate Impurity B is manufactured under a quality management system and undergoes rigorous analytical characterization to ensure identity, purity, and consistency. Our products are suitable for use as pharmaceutical reference standards in compliance with ICH guidelines Q3B(R2) and relevant pharmacopeial expectations. Comprehensive Certificates of Analysis (COA) are provided, detailing results from advanced techniques such as HPLC, NMR, and MS for full structural confirmation and purity assessment.

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 compound is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

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%
Water Content (KF)	10.0% - 13.0% (Theoretical for Trihydrate: ~12.35%)
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unspecified impurity ≤ 1.0%
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.