Description

Phenoxymethylpenicillin Potassium Impurity F Hcl is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for quality control and regulatory compliance in the pharmaceutical industry, specifically for the analysis of Penicillin V (Phenoxymethylpenicillin) Potassium. It serves as a key impurity marker for ensuring the safety, efficacy, and purity of the final antibiotic product. Pharmaceutical manufacturers, analytical laboratories, and research institutions require this standard for method development, validation, and routine testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Penicillin V Potassium active pharmaceutical ingredients (APIs) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating HPLC, UPLC, or LC-MS methods to accurately identify and quantify this specific impurity.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing a characterized impurity for stability studies and specification setting.
• Research & Degradation Studies: Used in forced degradation and stability studies to understand the degradation pathways of Penicillin V Potassium.
• Pharmacopoeial Testing: Applicable for testing in compliance with monographs from USP (United States Pharmacopeia), EP (European Pharmacopoeia), and other international pharmacopoeias.
• Calibration & System Suitability: Serves as a calibration standard to ensure the precision and accuracy of analytical instrumentation.

Basic Information

Product Name	Phenoxymethylpenicillin Potassium Impurity F Hcl
CAS No.	196701-54-9
Molecular Formula	C₁₆H₁₈N₂O₅S • HCl
Molecular Weight	386.85 g/mol (Free base: 350.39 g/mol)
Synonyms	Penicillin V Potassium Impurity F Hydrochloride; (2S,5R,6R)-3,3-Dimethyl-7-oxo-6-[(phenoxyacetyl)amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid hydrochloride; 6-Phenoxyacetamidopenicillanic acid hydrochloride; Phenoxymethylpenicillanic acid hydrochloride; Pen V Impurity F HCl
EINECS	Contact for details

Quality Control

Every batch of Phenoxymethylpenicillin Potassium Impurity F Hcl is manufactured and handled under strict quality management systems. The product undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, MS), and water content analysis, to ensure it meets the high standards required for pharmaceutical reference materials. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming batch-specific results and traceability.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under 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)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 1.0%

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