Description

Clavulanate Potassium Impurity 12 Dihcl (Clavulanate Potassium Ep Impurity M Dihcl) is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and regulatory compliance of Clavulanate Potassium, a key β-lactamase inhibitor used in combination antibiotics. It is essential for analytical laboratories and pharmaceutical manufacturers engaged in method validation, stability studies, and ensuring drug safety profiles. The precise characterization of this impurity is fundamental to meeting stringent pharmacopeial standards for active pharmaceutical ingredients (APIs).

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Clavulanate Potassium API batches.
• Analytical Method Development & Validation: Critical for developing and validating HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Indicating Studies: Employed to monitor degradation pathways and establish shelf-life specifications for finished pharmaceutical formulations containing Clavulanate Potassium.
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing necessary impurity profiles and characterization data as per ICH guidelines.
• Pharmacopeial Testing: Used in testing to comply with monographs from USP (United States Pharmacopeia), EP (European Pharmacopoeia), or other international pharmacopeias.
• Research & Development: Facilitates synthetic route optimization and impurity fate and tolerance studies during API process development.

Basic Information

Product Name	Clavulanate Potassium Impurity 12 Dihcl (Clavulanate Potassium Ep Impurity M Dihcl)
CAS No.	103526-47-2
Molecular Formula	C8H11KN2O7·2HCl
Molecular Weight	367.20 g/mol (for free base, excluding HCl salts; contact for exact salt form weight)
Synonyms	Clavulanate Potassium Impurity M Dihydrochloride; Clavulanic Acid Impurity M Dihydrochloride; (2R,3Z,5R)-3-(2-Hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid Potassium Salt Impurity M Dihydrochloride; EP Impurity M of Clavulanate Potassium Dihydrochloride; Clavulanate Potassium Related Compound M Dihydrochloride; Clavulanate Potassium Specified Impurity 12 Dihydrochloride
EINECS	Contact for details

Quality Control

Every batch of Clavulanate Potassium Impurity 12 Dihcl is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC/UPLC) and spectroscopic (NMR, MS) techniques to ensure it meets the exacting standards required for a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting compliance with ICH Q3A, Q3B, and relevant pharmacopeial guidelines.

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) and must be kept under inert conditions or in a desiccator after opening to maintain stability and purity. For long-term storage, consider storing at 2-8°C.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with reference structure
Purity (HPLC)	≥ 95.0%
Assay (on dried basis)	90.0% - 110.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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