Description

Spectinomycin Ep Impurity F is a high-purity chemical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity and safety of the antibiotic spectinomycin by serving as a known impurity marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of antibiotic formulations.

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 & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to ensure spectinomycin meets stringent pharmacopeial specifications (e.g., EP, USP, ICH guidelines) for impurity limits.
• Stability Studies: Used to track the formation of degradation products in spectinomycin under various storage conditions over time.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., CMC sections for FDA, EMA) by providing definitive impurity characterization data.
• Research & Development: Facilitates research into the synthesis, degradation pathways, and metabolism of spectinomycin and related compounds.

Basic Information

Product Name	Spectinomycin Ep Impurity F
CAS No.	1323437-06-4
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Spectinomycin Impurity F; Spectinomycin Related Compound F; Spectinomycin EP Impurity F; (1R,3S,5R,8R,10R,11S,12S,13R,14S)-13-[(2R,5S,6R)-5-(dimethylamino)-6-methyloxan-2-yl]oxy-12-ethyl-4,7,9,11,14-pentahydroxy-3,5,8,10,12,14-hexamethyl-1,6-dioxaspiro[4.5]decan-2-one; Spectinomycin Process Impurity; Spectinomycin Degradant
EINECS	Contact for details

Quality Control

Our Spectinomycin Ep Impurity F is manufactured under strict quality systems to ensure it meets the exacting standards required for pharmaceutical impurity analysis. Each batch is characterized and tested using advanced analytical techniques, including HPLC and MS, to confirm identity and purity. A comprehensive Certificate of Analysis (COA) is provided with each lot, detailing batch-specific results. Our quality commitment aligns with cGMP principles and supports compliance with ICH Q3A/B and relevant pharmacopeial (EP/USP) guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Meets ICH limits

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