Description

Demeclocycline Ep Impurity C is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of demeclocycline hydrochloride, a tetracycline-class antibiotic. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control testing.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of demeclocycline-related substances in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or LC-MS methods to monitor impurities during the manufacturing process.
• Quality Control & Assurance: Serves as a system suitability and calibration standard in routine QC testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., EP, USP).
• Stability Studies: Employed to track the formation of degradation products in demeclocycline formulations under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Used in metabolic studies, pharmacokinetic research, and impurity profiling to understand the chemical behavior of demeclocycline.

Basic Information

Product Name	Demeclocycline Ep Impurity C
CAS No.	129044-45-7
Molecular Formula	C₂₁H₂₁ClN₂O₈
Molecular Weight	464.86 g/mol
Synonyms	6-Desmethyl-6-deoxytetracycline; 7-Chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-pentahydroxy-1,11-dioxo-2-naphthacenecarboxamide; Demeclocycline Impurity C; Demeclocycline Related Compound C; EP Impurity C of Demeclocycline; Demeclocycline European Pharmacopoeia Impurity C
EINECS	Contact for details

Quality Control

Our Demeclocycline Ep Impurity C is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a comprehensive Certificate of Analysis (COA) with each shipment, detailing the results against stringent in-house specifications aligned with pharmacopeial expectations. Our quality commitment ensures material suitable for regulatory filing and GMP-compliant laboratory use.

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 light-sensitive; therefore, containers must be kept tightly sealed and stored in a desiccated environment away from direct light exposure to maintain stability and purity.

Specification

Item	Specification
Appearance	Yellow to light brown powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH guidelines

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