Description

Spectinomycin Ep Impurity G 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 Spectinomycin, a broad-spectrum aminocyclitol antibiotic, by serving as a known impurity marker. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and quality assurance. The product is supplied with comprehensive analytical data to support method validation and regulatory compliance.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Spectinomycin active pharmaceutical ingredient (API) and finished drug products.
• Critical component in analytical method development and validation (HPLC, UPLC, LC-MS) for Spectinomycin quality control.
• Essential for regulatory compliance and submission to agencies like the FDA and EMA, requiring impurity profiling.
• Used in stability studies to monitor the formation of degradation products in Spectinomycin formulations over time.
• Serves as a calibration standard in pharmacopeial testing to ensure Spectinomycin meets USP/EP/BP monograph specifications.
• Valuable for research and development of Spectinomycin synthesis processes to understand and control impurity formation.

Basic Information

Product Name	Spectinomycin Ep Impurity G
CAS No.	1323437-07-5
Molecular Formula	C₁₄H₂₄N₂O₇
Molecular Weight	332.35 g/mol
Synonyms	(1R,3S,5R,8R,10S,12S,13R,14S)-4,12-Diamino-2,7,9,11,13-pentahydroxy-14-methyl-3,5,8,10-tetrahydro-1H,6H-pyrano[3,2-b]xanthene-1,6-dione; Spectinomycin Related Compound G; Spectinomycin Impurity G; Spectinomycin EP Impurity G; Spectinomycin USP Impurity G; Actinospectacin Impurity G; Decahydro-4a,7,9-trihydroxy-2-methyl-6,8-bis(methylamino)-4H-pyrano[2,3-b][1,4]benzodioxin-4-one Impurity G
EINECS	Contact for details

Quality Control

Every batch of Spectinomycin Ep Impurity G is manufactured and controlled under a strict quality management system. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC and LC-MS to ensure it meets the exacting standards required for a pharmaceutical reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality commitment aligns with the requirements for chemicals used in pharmaceutical development under GMP guidelines.

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 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 (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 95.0%
Purity (HPLC, Area %)	≥ 98.0%
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.