Description

Amphotericin B Ep Impurity C is a specified impurity of the antifungal drug Amphotericin B, identified by the CAS registry number 136135-61-0. This high-purity reference standard is critical for pharmaceutical research, development, and quality control, ensuring the safety and efficacy of the final drug product. It is primarily required by analytical laboratories and manufacturers in the pharmaceutical industry for method validation, stability studies, and regulatory compliance testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of Amphotericin B Ep Impurity C in drug substances and products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity profiling.
• Quality Control & Batch Release Testing: Essential for routine quality control testing to ensure drug substance and product purity meets pharmacopeial (e.g., EP, USP) specifications.
• Stability Studies: Employed to monitor the formation of this specific impurity over time under various storage conditions, supporting shelf-life determination.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., CMC sections for FDA, EMA) to demonstrate comprehensive impurity control.
• Research on Degradation Pathways: Aids in understanding the degradation chemistry of Amphotericin B, helping to improve formulation stability.

Basic Information

Product Name	Amphotericin B Ep Impurity C
CAS No.	136135-61-0
Molecular Formula	C47H73NO17
Molecular Weight	924.08 g/mol
Synonyms	Amphotericin B Impurity C; Amphotericin B Related Compound C; (1R,3S,5R,6R,9R,11R,15S,16R,17R,18S,19E,21E,23E,25E,27E,29E,31E,33R,35S,36R,37S)-33-[(2R,3S,4S,5S,6R)-4-Amino-3,5-dihydroxy-6-methyloxan-2-yl]oxy-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicyclo[33.3.1]nonatriaconta-19,21,23,25,27,29,31-heptaene-36-carboxylic acid; European Pharmacopoeia Amphotericin B Impurity C
EINECS	Contact for details

Quality Control

Our Amphotericin B Ep Impurity C is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

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 low-humidity environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	Yellow to brownish-yellow powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
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.