Description

Cefaclor Impurity K is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the antibiotic Cefaclor by accurately identifying and quantifying related substances. It is an essential material for analytical laboratories, quality assurance departments, and research institutions within the pharmaceutical and fine chemical industries.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in Cefaclor Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to ensure Cefaclor meets pharmacopoeial specifications (e.g., USP, EP, JP).
• Stability Studies: Employed to monitor the formation of degradation products in Cefaclor under various stress conditions (e.g., heat, humidity, light).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA) to comply with FDA, EMA, and ICH guidelines.
• Research & Development: Used in synthetic chemistry research to study the degradation pathways and metabolism of Cefaclor.

Basic Information

Product Name	Cefaclor Impurity K
CAS No.	21746-02-1
Molecular Formula	C15H14ClN3O4S
Molecular Weight	367.81 g/mol
Synonyms	(6R,7R)-7-[[(2R)-2-Amino-2-phenylacetyl]amino]-3-chloro-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid; 3-Chloro-7-D-phenylglycylamido-3-cephem-4-carboxylic Acid; δ-3-Cefaclor; Cefaclor δ-3-Isomer; Cefaclor Impurity C (EP); Cefaclor Related Compound K (USP); Antibiotic 34355 Impurity K
EINECS	Contact for details

Quality Control

Our Cefaclor Impurity K is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis, to ensure it meets the stringent requirements for a pharmaceutical reference standard. Certificates of Analysis (COA) with detailed chromatograms and spectral data are provided, supporting compliance with ICH Q3A, Q3B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container should be kept in a desiccated environment to prevent moisture uptake. For long-term storage, consider storing under an inert atmosphere.

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)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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