Description

Ampicillin Impurity F is a specified impurity of the β-lactam antibiotic Ampicillin, identified by CAS No. 124774-48-7. This compound is critical for pharmaceutical research and development, serving as a key reference standard in the analytical profiling and quality control of Ampicillin drug substances and products. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure drug purity, safety, and compliance with stringent pharmacopeial standards such as USP, EP, and ICH guidelines.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Ampicillin API and finished dosage forms.
• Critical component in analytical method development and validation (e.g., HPLC, UPLC) for stability-indicating assays.
• Essential for conducting stability studies and degradation pathway elucidation of Ampicillin-based drugs.
• Used in regulatory compliance and submission packages to meet ICH Q3A(R2) and Q3B(R2) requirements for impurity reporting.
• Supports quality control laboratories in routine batch release testing and specification setting.
• Valuable for academic and industrial research into the chemistry, metabolism, and synthesis of β-lactam antibiotics.

Basic Information

Product Name	Ampicillin Impurity F
CAS No.	124774-48-7
Molecular Formula	C16H19N3O4S
Molecular Weight	349.41 g/mol
Synonyms	(2S,5R,6R)-6-[[(2R)-2-Amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Ampicillin Related Compound F; D-α-Aminobenzylpenicillin Impurity F; Ampicillin EP Impurity F; Ampicillin USP Related Substance F; 6-(D-α-Aminophenylacetamido)penicillanic acid impurity F
EINECS	Contact for details

Quality Control

Every batch of Ampicillin Impurity F is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for use as a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and traceability. Our quality commitment aligns with cGMP principles and supports compliance with major pharmacopeias (USP, EP).

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 material is hygroscopic (moisture-sensitive); therefore, 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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Single unspecified impurity ≤ 2.0% Total impurities ≤ 5.0%
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.