Description

Ertapenem Impurity 17 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Ertapenem. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The product is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the quality control and release testing of Ertapenem API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods for impurity identification and quantification.
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs).
• Stability Studies: Employed to monitor the formation and levels of this specific impurity during forced degradation and long-term stability testing of Ertapenem.
• Research & Development: Used in R&D laboratories to study the degradation pathways, pharmacokinetics, and toxicological profiles of Ertapenem-related substances.
• Calibration & System Suitability: Serves as a system suitability test component and for calibrating analytical instruments to ensure accurate impurity detection.

Basic Information

Product Name	Ertapenem Impurity 17
CAS No.	402955-34-4
Molecular Formula	C22H25N3O7S2
Molecular Weight	507.58 g/mol
Synonyms	(1R,5S,6S)-2-[(3S,5S)-5-[(3-Carboxyphenyl)carbamoyl]pyrrolidin-3-yl]sulfanyl-6-[(1R)-1-hydroxyethyl]-1-methylcarbapen-2-em-3-carboxylic acid; (4R,5S,6S)-3-[[(3S,5S)-5-[[(3-Carboxyphenyl)amino]carbonyl]-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic Acid; Ertapenem Related Compound; Ertapenem Degradant; Ertapenem Process Impurity
EINECS	Contact for details

Quality Control

Our Ertapenem Impurity 17 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis to ensure compliance with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing all test results, including chromatograms and spectra, is provided with every shipment to support your GMP and regulatory requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. Due to its hygroscopic nature, the product should be stored in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
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.