Description

Ampicillin Impurity 12 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the antibiotic Ampicillin and its related pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Ampicillin Active Pharmaceutical Ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., ANDA, NDA) by providing data for impurity identification and qualification as per ICH Q3A(R2) and Q3B(R2) guidelines.
• Stability Studies: Employed in forced degradation and long-term stability studies to monitor impurity formation and understand the degradation pathways of Ampicillin.
• Research & Development: Serves as a key intermediate or marker in synthetic chemistry research and the development of purification processes for Ampicillin.
• Quality Control Testing: Acts as a system suitability standard and a calibrant in routine batch release testing to ensure product purity and consistency.

Basic Information

Product Name	Ampicillin Impurity 12
CAS No.	281670-46-0
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; Ampicillin EP Impurity; Ampicillin USP Related Substance; D-α-Aminobenzylpenicillin Impurity; 6-[D(-)-α-Aminophenylacetamido]penicillanic acid impurity
EINECS	Contact for details

Quality Control

Every batch of Ampicillin Impurity 12 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure high purity and structural identity suitable for use as a reference standard. A comprehensive Certificate of Analysis (COA) detailing purity, impurities, and analytical methods is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% 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.