Description

Cefteram Pivoxil is a third-generation oral cephalosporin prodrug antibiotic, hydrolyzed in vivo to the active metabolite cefteram. It delivers potent bactericidal activity against a broad spectrum of Gram-positive and Gram-negative pathogens, with enhanced stability against many β-lactamases. This makes it a critical intermediate for pharmaceutical formulation development and high-purity active pharmaceutical ingredient (API) manufacturing. Global pharmaceutical manufacturers, contract development and manufacturing organizations (CDMOs), and regulatory-compliant API suppliers rely on rigorously controlled Cefteram Pivoxil CAS NO 82547-81-7 for robust process validation and consistent clinical-grade output.

Application

• Active Pharmaceutical Ingredient (API) synthesis for oral cephalosporin antibiotics
• Reference standard in pharmacopeial testing (USP, EP, JP)
• Stability-indicating method development and validation for HPLC and LC-MS assays
• Raw material in GMP-compliant solid oral dosage form manufacturing (tablets, capsules)
• Pharmaceutical research & development of β-lactamase-stable antibiotic derivatives
• Quality control reference for dissolution, content uniformity, and impurity profiling
• Pre-formulation studies including polymorph screening and excipient compatibility testing
• Regulatory submission batches requiring full traceability and COA documentation

Basic Information

Product Name	Cefteram Pivoxil
CAS No.	82547-81-7
Molecular Formula	C20H23N5O7S
Molecular Weight	477.49 g/mol
Synonyms	Cefteram pivoxil; Cefteram pivaloyloxymethyl ester; (6R,7R)-7-[(Z)-2-(2-Aminothiazol-4-yl)-2-methoxyiminoacetamido]-3-[[(1-methyl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid 1-(pivaloyloxy)ethyl ester; FK-037; FR-779; Cefteram pivaloyloxymethyl; Cefteram 1-(pivaloyloxy)ethyl ester; Cefteram pivoxilum
EINECS	Not listed (not assigned)

Quality Control

Our products undergo rigorous quality testing to ensure compliance with industry standards. Certificates of Analysis (COA) are available upon request. All batches meet stringent requirements for identity, assay, related substances, residual solvents, heavy metals, and microbiological limits per ICH Q5, Q6, and Q7 guidelines. Testing is performed using validated methods compliant with USP Chapter <1225>, EP 2.2.46, and ICH Q2(R2). Full traceability from raw materials to finished product is maintained under ISO 9001:2015 and ISO 13485:2016 certified systems.

Storage

Preserve in a tightly closed container, protected from light. Store at 15–25°C in a dry, well-ventilated area. Due to its hygroscopic nature, minimize exposure to ambient humidity; use desiccant packs during storage and handling. Avoid repeated opening of containers.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference standard
Assay (HPLC)	98.0% – 102.0%
Related Substances (HPLC)	Individual impurity ≤ 0.3%; Total impurities ≤ 1.0%
Residual Solvents (GC)	Meets ICH Q3C limits (e.g., methanol ≤ 3000 ppm, acetone ≤ 5000 ppm)
Water (Karl Fischer)	≤ 1.5%
Heavy Metals	≤ 10 ppm
Microbial Limits	Total aerobic count ≤ 100 CFU/g; Absence of E. coli, Salmonella, Staphylococcus aureus

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