Description

Amikacin Impurity 12 is a designated chemical reference standard used in the analytical profiling of the antibiotic Amikacin. This compound is critical for pharmaceutical research and development, serving as a key marker for ensuring the purity, safety, and efficacy of Amikacin-based drug substances and products. It is primarily utilized by quality control laboratories, regulatory agencies, and manufacturers in the pharmaceutical and biotechnology industries for method development, validation, and compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Amikacin sulfate active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods to monitor impurity profiles during stability studies.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to ensure Amikacin drug substances and products meet stringent pharmacopeial specifications (e.g., USP, EP, JP).
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., CMC sections for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and marketing applications.
• Stability Studies: Employed as a marker to track the formation of degradation products under various stress conditions (e.g., heat, light, humidity) as per ICH guidelines.
• Research on Degradation Pathways: Aids in understanding the chemical degradation mechanisms of Amikacin, facilitating the development of more stable formulations.

Basic Information

Product Name	Amikacin Impurity 12
CAS No.	40371-54-8
Molecular Formula	C22H43N5O13
Molecular Weight	585.61 g/mol
Synonyms	1-N-[(S)-4-Amino-2-hydroxybutyryl]-6'-N-methylkanamycin A; 6'-N-Methyl-1-N-[(S)-4-amino-2-hydroxybutanoyl]kanamycin A; Kanamycin A, 1-N-[(S)-4-amino-2-hydroxybutyryl]-6'-N-methyl-; Amikacin Related Compound; Amikacin EP Impurity G; Amikacin USP Related Compound; Antibiotic BB-K 311
EINECS	Contact for details

Quality Control

Every batch of Amikacin Impurity 12 is manufactured under controlled conditions and undergoes rigorous analytical characterization to ensure identity, purity, and consistency. Our quality system is designed to support its use as a reference standard. Comprehensive testing includes identification by spectroscopic methods (NMR, IR, MS), purity determination by HPLC, and control of residual solvents and moisture. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific data and traceability information.

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 should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

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%
Residual Solvents (GC)	Complies with ICH limits

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