Description

Doripenem Impurity 2 is a specified impurity and degradation product of the carbapenem antibiotic Doripenem. This compound is critical for pharmaceutical research and development, serving as a key reference standard for quality control and regulatory compliance. It is primarily used by analytical chemists and quality assurance professionals in the pharmaceutical industry for method development, validation, and ensuring the purity and safety of Doripenem drug substances and products.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Doripenem API and finished dosage forms.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during stability studies.
• Quality Control & Assurance: Critical for in-process testing and release testing of Doripenem batches to meet pharmacopeial standards (USP, EP, JP).
• Regulatory Compliance & Filing: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing necessary impurity characterization data.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity).
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and stability of carbapenem antibiotics.

Basic Information

Product Name	Doripenem Impurity 2
CAS No.	396717-61-6
Molecular Formula	C15H24N4O6S2
Molecular Weight	420.50 g/mol
Synonyms	(4R,5S,6S)-3-[[(3S,5S)-5-[(Dimethylamino)carbonyl]-3-pyrrolidinyl]thio]-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid; Doripenem Related Compound B; Doripenem EP Impurity B; Doripenem USP Impurity B; (1R,5S,6S)-2-[(3S,5S)-5-(Dimethylcarbamoyl)pyrrolidin-3-yl]thio-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-3-carboxylic acid; S-4661 Impurity
EINECS	Contact for details

Quality Control

Every batch of Doripenem Impurity 2 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements of pharmaceutical reference standard users. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, purity (by HPLC), and identification (by IR and/or MS). Specifications are aligned with pharmacopeial expectations for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, or as indicated on the label or COA. The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere at -20°C.

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)	Single unspecified impurity ≤ 1.0% 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.