Description

Panipenem-Betamipron is a fixed-dose combination antibiotic consisting of the carbapenem panipenem and the renal dehydropeptidase inhibitor betamipron. This synergistic formulation is specifically designed to enhance the therapeutic efficacy and renal safety profile of panipenem by preventing its degradation in the kidneys. It is a critical active pharmaceutical ingredient (API) for the manufacture of injectable antibacterial medications. Pharmaceutical companies and contract manufacturing organizations (CMOs) targeting serious bacterial infections require this high-purity compound for reliable drug production.

Application

• Primary Pharmaceutical Ingredient: Serves as the core active component in the formulation of injectable antibiotic drugs.
• Broad-Spectrum Antibacterial Formulations: Used in medications targeting a wide range of Gram-positive and Gram-negative bacteria, including resistant strains.
• Hospital-Acquired Infection (HAI) Treatments: Essential for producing drugs used to treat severe infections such as pneumonia, sepsis, and complicated urinary tract infections in clinical settings.
• Renal-Protected Carbapenem Therapy: Key for developing therapies where the betamipron component mitigates potential nephrotoxicity, allowing for safer administration of panipenem.
• Antibiotic Drug Development: Used in research and development for new antibacterial agents and combination therapies.
• GMP Manufacturing: Supplied as a raw material for pharmaceutical production under Good Manufacturing Practice (GMP) guidelines.

Basic Information

Product Name	Panipenem-Betamipron
CAS No.	138240-65-0
Molecular Formula	C15H21N4O4S2 • C11H13NO3
Molecular Weight	Panipenem: 385.48 g/mol; Betamipron: 207.23 g/mol (Combined: 592.71 g/mol for the salt/complex)
Synonyms	Panipenem/Betamipron (1:1); Panipenem with Betamipron; Panipenem-Betamipron Complex; (5R,6S)-2-[(4R)-2-Oxo-4-[(pyrrolidin-3-ylthio)methyl]-1-azetidinyl]-6-[(1R)-1-hydroxyethyl]-1-carbapen-2-em-3-carboxylic acid compound with N-Benzoyl-β-alanine; PAPM/BP; Carbapenem-BP
EINECS	Contact for details

Quality Control

Our Panipenem-Betamipron is manufactured and tested to meet stringent pharmaceutical-grade standards. Quality assurance protocols include comprehensive analytical testing for identity, potency, and purity, ensuring compliance with relevant pharmacopeial guidelines. A detailed Certificate of Analysis (COA) is provided with each batch, documenting results for assay, related substances, residual solvents, and microbiological quality. We support our partners with the documentation necessary for regulatory submissions and GMP audits.

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 product is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 2.0%
Related Substances (HPLC)	Total impurities ≤ 2.0%; Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Bacterial Endotoxins	< 0.05 EU/mg
Microbial Enumeration	Complies with Ph. Eur. 2.6.12/2.6.13

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