Description

Cefprozil Impurity L CAS NO 203007-73-2 is a specified impurity and reference standard used in the analytical profiling of the antibiotic Cefprozil. This high-purity chemical is critical for pharmaceutical research, development, and quality control processes, ensuring the safety and efficacy of the final drug product. It is primarily required by analytical laboratories, quality assurance departments, and regulatory bodies for method validation, impurity identification, and batch release testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the quantitative and qualitative analysis of Cefprozil and its related substances.
• Impurity Profiling & Identification: Used in HPLC, LC-MS, and other chromatographic methods to identify, characterize, and quantify Impurity L in Cefprozil active pharmaceutical ingredient (API) and finished dosage forms.
• Method Development & Validation: Essential for developing, optimizing, and validating stability-indicating analytical methods as per ICH guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to monitor impurity levels and ensure batches comply with pharmacopeial specifications (USP, EP, CP).
• Stability Studies: Used as a marker to track the formation of degradation products during forced degradation and long-term stability studies of Cefprozil.
• Regulatory Submissions: Provides necessary data and reference materials for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity control.

Basic Information

Product Name	Cefprozil Impurity L
CAS No.	203007-73-2
Molecular Formula	C18H19N3O5S
Molecular Weight	389.43 g/mol
Synonyms	(6R,7R)-7-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-8-oxo-3-[(1E)-prop-1-en-1-yl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid; Cefprozil Related Compound L; Cefprozil EP Impurity L; Cefprozil USP Impurity L; Cefprozil δ-3 Isomer; (Z)-Cefprozil Impurity
EINECS	Contact for details

Quality Control

Every batch of Cefprozil Impurity L is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, LC-MS, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C, in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled under inert atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%

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