Description

Alimemazine Ep Impurity B is a specified impurity and reference standard used in the pharmaceutical development and quality control of Alimemazine. This compound is critical for ensuring the purity, safety, and efficacy of the final drug product by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, stability studies, and compliance with stringent pharmacopeial standards.

Application

• Primary use as a pharmaceutical reference standard for the identification and quantification of impurities in Alimemazine active pharmaceutical ingredient (API) and finished dosage forms.
• Critical component in analytical method development and validation (HPLC, GC, LC-MS) to ensure specificity and accuracy.
• Essential for conducting stability and forced degradation studies to understand the degradation pathways of Alimemazine.
• Used in quality control (QC) laboratories for routine batch release testing against established specifications.
• Serves as a system suitability standard in regulatory submissions to agencies like the FDA and EMA.
• Valuable for research and development in synthetic chemistry to study impurity formation and mitigation strategies.

Basic Information

Product Name	Alimemazine Ep Impurity B
CAS No.	22732-04-3
Molecular Formula	C₁₈H₂₂N₂S
Molecular Weight	298.45 g/mol
Synonyms	Trimeprazine Impurity B; Alimemazine Related Compound B; 10H-Phenothiazine-10-propanamine, N,N,β-trimethyl-; (±)-Trimeprazine Impurity B; Promethazine, 10-[3-(dimethylamino)-2-methylpropyl]-; N,N,β-Trimethyl-10H-phenothiazine-10-propanamine
EINECS	Contact for details

Quality Control

Every batch of Alimemazine Ep Impurity B is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including chromatographic purity (HPLC), identity confirmation (IR, NMR), and residual solvent analysis, to ensure it meets the high standards required for pharmaceutical impurity standards. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with specified criteria and traceability.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. 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 matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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