Description

Amoxicillin Impurity 14/Amoxicillin Ep Impurity P is a high-purity 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 amoxicillin-based drug products by enabling the accurate identification and quantification of this specific impurity. It is an essential material for analytical chemists, quality assurance laboratories, and research institutions focused on antibiotic development and pharmacopeial compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material for the identification and quantification of impurities in Amoxicillin API and finished drug products.
• Method Development & Validation: Critical for developing and validating analytical methods, particularly HPLC and UPLC, in compliance with ICH Q2(R1) and pharmacopeial guidelines.
• Quality Control & Assurance: Used in routine QC testing of amoxicillin batches to monitor impurity profiles and ensure they meet stringent specifications (e.g., USP, EP, JP).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of amoxicillin.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development: Facilitates research into the synthesis, metabolism, and toxicological profile of amoxicillin-related substances.

Basic Information

Product Name	Amoxicillin Impurity 14/Amoxicillin Ep Impurity P
CAS No.	185802-22-6
Molecular Formula	C₁₆H₁₉N₃O₅S
Molecular Weight	365.41 g/mol
Synonyms	(2S,5R,6R)-6-[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Amoxicillin Impurity P (EP); Amoxicillin Related Compound P; Amoxicillin EP Impurity P; Amoxicillin Impurity 14; (4S)-2-(4-Hydroxyphenyl)glycyl]amoxicillin; Amoxicillin dimer impurity; Contact for additional synonyms.
EINECS	Contact for details

Quality Control

Every batch of Amoxicillin Impurity 14 is manufactured and tested under strict quality management systems. The material undergoes comprehensive analytical characterization using techniques including HPLC, NMR, and MS to confirm identity and ensure high purity suitable for use as a reference standard. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data on purity, impurities, and chromatographic profiles. Our quality systems are designed to support compliance with cGMP and relevant pharmacopeial guidelines (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum conforms to reference spectrum
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.