Description

Spectinomycin Ep Impurity E is a high-purity chemical reference standard, specifically identified as a known impurity of the antibiotic Spectinomycin. This compound is critical for analytical method development, validation, and quality control processes in pharmaceutical manufacturing. It is primarily utilized by research institutions, quality assurance laboratories, and API producers involved in the synthesis and purification of Spectinomycin to ensure final product safety and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Spectinomycin active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor Spectinomycin purity and stability.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard in routine QC testing to comply with pharmacopeial monographs (e.g., EP, USP).
• Regulatory Compliance & Filing: Supports regulatory submissions (e.g., to FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed in forced degradation and long-term stability studies of Spectinomycin to understand degradation pathways.
• Research & Development: Used in chemical research to study the metabolism, synthesis pathways, and degradation profiles of Spectinomycin-related compounds.

Basic Information

Product Name	Spectinomycin Ep Impurity E
CAS No.	88270-91-1
Molecular Formula	C₁₄H₂₄N₂O₇
Molecular Weight	332.35 g/mol
Synonyms	Spectinomycin Related Compound E; Spectinomycin Impurity E; Dihydrospectinomycin; Actinospectacin Impurity E; 4H-Pyrano[2,3-b][1,4]benzodioxin-4-one, 9,10-dihydro-3,4,7,8,10-pentahydroxy-9-(hydroxymethyl)-2,6-dimethyl-, (3R,4R,6R,7R,9R,10R)-; UNII-9P4CY9FJ7V; Spectinomycin EP Impurity E
EINECS	Contact for details

Quality Control

Every batch of Spectinomycin Ep Impurity E is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, NMR), to ensure it meets the high standards required for pharmaceutical reference materials. 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). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment. For long-term storage, consider storing under an inert atmosphere.

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%
Residue on Ignition	≤ 0.5%
Heavy Metals	≤ 20 ppm
Specific Optical Rotation	Contact for details

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