Description

Cloxacillin Ep Impurity A is a specified impurity used in the quality control and analytical profiling of the antibiotic Cloxacillin Sodium. This high-purity reference standard is critical for pharmaceutical manufacturers and analytical laboratories to ensure the safety, efficacy, and regulatory compliance of their drug products. It is essential for method development, validation, and routine testing in the production of β-lactam antibiotics.

Application

• Primary use as a certified reference standard for impurity identification and quantification in Cloxacillin Sodium API and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, UPLC) for stability-indicating assays.
• Used in pharmaceutical research and development to study degradation pathways and impurity profiles.
• Essential for regulatory compliance and submission to agencies like the FDA, EMA, and other global health authorities.
• Supports quality control (QC) laboratories in pharmacopoeial testing (EP, USP) and batch release.
• Employed in stability studies to monitor impurity levels over the shelf-life of drug products.

Basic Information

Product Name	Cloxacillin Ep Impurity A
CAS No.	1642629-96-6
Molecular Formula	C19H17ClN3NaO5S
Molecular Weight	457.87 g/mol
Synonyms	(2S,5R,6R)-6-[[(2R)-2-Amino-2-(3-chloro-2-hydroxyphenyl)acetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid; Cloxacillin Impurity A (EP); Cloxacillin Related Compound A; 5-Methyl-3-phenyl-4-isoxazolyl Penicillin Impurity A; Aminopenicillanic Acid Derivative Impurity; Cloxacillin Degradant; Cloxacillin Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Cloxacillin Ep Impurity A is manufactured and controlled under a strict quality management system. The material undergoes comprehensive analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A detailed Certificate of Analysis (COA) providing batch-specific data is supplied with each shipment, supporting compliance with cGMP and pharmacopoeial guidelines (EP/USP).

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 compound is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity. For long-term storage, consider desiccated conditions.

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 unknown 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.