Description

Amikacin Impurity D CAS NO 1174286-24-8 is a specified impurity of the broad-spectrum aminoglycoside antibiotic, Amikacin. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring of this specific impurity during drug manufacturing. It is an essential material for analytical laboratories, regulatory compliance, and the production of Amikacin API and finished dosage forms, ensuring product safety and efficacy.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Amikacin Impurity D in drug substances and products.
• Method Development and Validation: Essential for developing and validating analytical methods, such as HPLC and LC-MS, for impurity profiling of Amikacin.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor and control the levels of this specific impurity to ensure compliance with pharmacopoeial limits (e.g., USP, EP, ICH guidelines).
• Stability Studies: Used to identify and track the formation of Impurity D in Amikacin formulations under various stress conditions and throughout shelf-life studies.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., ANDA, NDA) to demonstrate thorough impurity control strategies.
• Research and Development: Supports synthetic chemistry research aimed at understanding impurity formation pathways and developing purer synthetic processes for Amikacin.

Basic Information

Product Name	Amikacin Impurity D
CAS No.	1174286-24-8
Molecular Formula	C22H43N5O13
Molecular Weight	585.60 g/mol
Synonyms	1-N-[(S)-4-Amino-2-hydroxybutyryl]-6'-N-methylkanamycin A; 6'-N-Methylamikacin; 1-N-[(2S)-4-Amino-2-hydroxybutanoyl]-6'-N-methylkanamycin A; Kanamycin A, 1-N-[(2S)-4-amino-2-hydroxy-1-oxobutyl]-6'-N-methyl-; Amikacin EP Impurity D; Amikacin Related Compound D
EINECS	Contact for details

Quality Control

Our Amikacin Impurity D is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, MS, and NMR. We ensure compliance with relevant pharmacopoeial standards and ICH guidelines for impurities in new drug substances.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a desiccated environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
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.