Description

Sancycline 7-Ethylmethylamino Impurity is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products derived from or related to sancycline. It is primarily required by analytical laboratories and R&D departments in the pharmaceutical and biotechnology sectors for method development, validation, and impurity profiling.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of the 7-Ethylmethylamino impurity in sancycline active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating precise HPLC, UPLC, or LC-MS methods to monitor impurity levels in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine quality control testing in pharmaceutical manufacturing to ensure batch-to-batch consistency and purity.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this specific degradation product under various stress conditions.
• Regulatory Submissions: Provides necessary data and characterization for regulatory filings (e.g., with FDA, EMA) to establish impurity thresholds and justify specifications.
• Research on Tetracycline Derivatives: Used in academic and industrial research focused on the synthesis, metabolism, and structure-activity relationships (SAR) of tetracycline-class antibiotics.

Basic Information

Product Name	Sancycline 7-Ethylmethylamino Impurity
CAS No.	32598-29-1
Molecular Formula	C23H27N3O7
Molecular Weight	457.48 g/mol
Synonyms	7-(Ethylmethylamino)-6-demethyl-6-deoxytetracycline; 7-Ethylmethylamino-6-demethyl-6-deoxytetracycline; 6-Deoxy-6-demethyl-7-(ethylmethylamino)tetracycline; Sancycline EP Impurity C; Sancycline Impurity C; Sancycline Related Compound C; 7-(N-Ethyl-N-methylamino)-6-demethyl-6-deoxytetracycline
EINECS	Contact for details

Quality Control

Every batch of Sancycline 7-Ethylmethylamino Impurity is manufactured and controlled under a strict quality management system. The product undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high 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 at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing at 2-8°C. The container should be kept in a well-ventilated area.

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	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.