Description

Vitamin B12 mixture with [4S(4a,4aa,5aa,6,12aa)]-7-chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,-12a-octahydro-3,6,10,12,12a penta-hydroxy-6-methyl-1,11-dioxo-2-naphthacencarbonamide (control for chlorotetracycline) is a specialized chemical reference standard primarily used for analytical and quality control purposes. This compound is critically important for ensuring the accuracy and reliability of assays in the pharmaceutical and biotechnology sectors, particularly in the analysis of tetracycline antibiotics. It serves as a key control material for researchers, analytical laboratories, and manufacturers requiring precise calibration and validation of their testing methodologies.

Application

• Pharmaceutical Reference Standard: Primary use as a certified control substance for the identification and quantification of chlorotetracycline and related tetracycline antibiotics in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating High-Performance Liquid Chromatography (HPLC), Liquid Chromatography-Mass Spectrometry (LC-MS), and other spectroscopic methods.
• Quality Control (QC) & Quality Assurance (QA): Used in internal and regulatory QC/QA laboratories to verify the purity, potency, and consistency of antibiotic manufacturing processes.
• Research & Development: Supports biochemical and microbiological research involving tetracycline-class antibiotics, including studies on mechanism of action, resistance, and degradation pathways.
• Regulatory Compliance Testing: Aids in compliance testing for markets governed by FDA, EMA, and other global health authorities, ensuring products meet stringent pharmacopeial standards (e.g., USP, EP).
• Veterinary Pharmaceutical Analysis: Used in the quality control of antibiotics intended for animal health applications.

Basic Information

Item	Details
Product Name	Vitamin B12 mixture with [4S(4a,4aa,5aa,6,12aa)]-7-chloro-4-(dimethylamino)-1,4,4a,5,5a,6,11,-12a-octahydro-3,6,10,12,12a penta-hydroxy-6-methyl-1,11-dioxo-2-naphthacencarbonamide (control for chlorotetracycline)
CAS No.	8021-83-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Chlorotetracycline Control Substance; CTC Control Standard; 7-Chlorotetracycline Related Compound; Aureomycin Control; Tetracycline Antibiotic Reference Material; Vitamin B12-Chlorotetracycline Mixture; Analytical Reference Standard 8021-83-8
EINECS	Contact for details

Quality Control

Our reference standards are produced and handled under strict quality management systems. Each batch of this Vitamin B12 mixture with chlorotetracycline control undergoes rigorous identity confirmation, purity analysis, and stability testing. A comprehensive Certificate of Analysis (COA) is provided, detailing results from advanced analytical techniques such as HPLC and NMR to ensure compliance with the high standards required for pharmaceutical reference materials. We support compliance with cGMP and relevant pharmacopeial 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). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to prevent degradation. For long-term stability, consider storage under inert atmosphere or with desiccant.

Specification

Item	Specification
Appearance	Yellow to Brownish Powder
Identification (HPLC)	Conforms to Reference Chromatogram
Identification (IR)	Conforms to Reference Spectrum
Assay (HPLC)	≥ 95.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Related Substances (HPLC)	Total impurities ≤ 3.0% Any single impurity ≤ 1.0%

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