Description

Meropenem Impurity A is a specified impurity and degradation product of the broad-spectrum carbapenem antibiotic, Meropenem. Its identification and control are critical for ensuring the purity, safety, and efficacy of the final pharmaceutical product. This reference standard is essential for analytical method development, validation, and routine quality control testing in pharmaceutical research and manufacturing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the qualitative and quantitative analysis of Meropenem drug substance and finished products.
• Analytical Method Development & Validation: Used to establish and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling and stability-indicating assays.
• Quality Control & Batch Release: Critical for monitoring impurity levels to ensure compliance with pharmacopeial monographs (e.g., USP, EP, JP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to identify and quantify degradation products formed under various stress conditions (e.g., heat, light, humidity, pH).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports studies on the degradation pathways and chemical stability of Meropenem.

Basic Information

Product Name	Meropenem Impurity A
CAS No.	1053703-36-8
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 Impurity A; Meropenem Related Compound A; Meropenem Degradant; Meropenem Open Ring Impurity; (4R,5S,6S)-3-[[(3S,5S)-5-(Dimethylcarbamoyl)-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid
EINECS	Contact for details

Quality Control

Our Meropenem Impurity A is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including identification (IR, NMR), purity determination by HPLC, and control of related impurities. We provide full traceability and Certificates of Analysis (COA) with detailed chromatographic data, confirming compliance with in-house specifications aligned with ICH guidelines. Materials are suitable for use as pharmaceutical reference standards in regulated environments.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, or as indicated on the certificate of analysis. The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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