Description

Spiramycin EP Impurity H (Neospiramycin III) is a high-purity chemical reference standard, specifically identified as a known impurity of the macrolide antibiotic Spiramycin. This compound is critical for pharmaceutical research, development, and quality control, enabling precise analytical method validation and impurity profiling. It is an essential material for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable reference standards to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Spiramycin EP Impurity H in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Used to develop, optimize, and validate High-Performance Liquid Chromatography (HPLC), UPLC, and LC-MS/MS methods for impurity analysis.
• Quality Control & Assurance (QC/QA): Serves as a critical benchmark in routine quality control testing to monitor impurity levels and ensure batch-to-batch consistency of Spiramycin API.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing definitive proof of impurity identity and supporting stability studies.
• Research on Degradation Pathways: Utilized in forced degradation studies to understand the stability profile and degradation behavior of Spiramycin under various stress conditions.
• Pharmacopoeial Testing: Essential for testing according to European Pharmacopoeia (EP) and other international pharmacopoeia monographs for Spiramycin.

Basic Information

Product Name	Spiramycin EP Impurity H (Neospiramycin III)
CAS No.	4617-99-6
Molecular Formula	C45H76N2O15
Molecular Weight	885.1 g/mol
Synonyms	Neospiramycin III; Spiramycin III; Foromacidin D; 4''-O-Acetylspiramycin I; Antibiotic A 649; (3R,4S,5S,6R,8R,9R,10E,12E,15R)-5-[(2S,3R,4S,6R)-4-(Dimethylamino)-3-hydroxy-6-methyloxan-2-yl]oxy-9-ethyl-8,15-dihydroxy-3,4,6,8,10,12,15-heptamethyl-1-oxacyclopentadeca-10,12-dien-2-one
EINECS	Contact for details

Quality Control

Every batch of Spiramycin EP Impurity H is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity analysis, and impurity profiling using advanced techniques such as HPLC, LC-MS, NMR, and IR spectroscopy to ensure they meet the exacting standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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 in a desiccated environment to maintain stability and purity. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm

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