Description

Cefazolin Impurity 12 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 antibiotic Cefazolin sodium. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of impurities in Cefazolin sodium active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development: Serves as a critical standard for developing and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed to monitor the formation of this specific degradant during forced degradation and long-term stability testing of Cefazolin formulations.
• Regulatory Compliance & Submissions: Essential for preparing regulatory documentation (e.g., for FDA, EMA) to demonstrate thorough impurity characterization as per ICH guidelines.
• Research & Development: Used in R&D to study the degradation pathways and chemical behavior of Cefazolin, aiding in process optimization.
• Quality Control Testing: Acts as a system suitability standard and for calibrating equipment to ensure accurate and reliable impurity analysis in batch release testing.

Basic Information

Product Name	Cefazolin Impurity 12
CAS No.	2364623-02-7
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Cefazolin Related Compound 12; Cefazolin EP Impurity 12; Cefazolin USP Impurity 12; Cefazolin Degradant 12; Cefazolin Sodium Impurity 12; (6R,7R)-3-[[(5-Methyl-1,3,4-thiadiazol-2-yl)thio]methyl]-8-oxo-7-[(1H-tetrazol-1-ylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (Potential IUPAC-like structure based on class)
EINECS	Contact for details

Quality Control

Our Cefazolin Impurity 12 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation by techniques such as IR and MS, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. The material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability.

Specification

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

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