General Information

Promethazine Impurities and Promethazine

Daicel Pharma offers high-graded Promethazine impurity standards, which include Promethazine EP Impurity A and Promethazine sulfoxide impurity. These impurities can impact the efficacy, quality, and safety of Promethazine. Daicel Pharma provides a custom synthesis of Promethazine impurities to meet specific client needs, offering global delivery options for convenience.

Promethazine [CAS: 60-87-7] is an N-dimethyl aminopropyl derivative of phenothiazine. Promethazine treats allergies, motion sickness, nausea, and vomiting.

Promethazine: Use and Commercial Availability 

Promethazine belongs to the phenothiazine class of compounds and treats Rhinitis, allergic conjunctivitis, allergic responses to blood or plasma, and dermographism. It is for promethazine cough syrup with phenylephrine and codeine to treat cold and allergy-related nasal congestion and cough and upper respiratory symptoms. This drug is available under various brand names such as Phenergan, Promethacon, Remsed, etc.

Promethazine Structure and Mechanism of Action 

The chemical name of Promethazine is N, N, α-Trimethyl-10H-phenothiazine-10-ethanamine. Its chemical formula is C₁₇H₂₀N₂S, and its molecular weight is approximately 284.4 g/mol.

Promethazine treats allergic reactions due to its antihistamine properties.

Promethazine Impurities and Synthesis 

Promethazine, a versatile compound with various therapeutic properties, may contain impurities that can impact its purity and efficacy. During the synthetic process¹, it ensures the purity of starting materials and the appropriate reaction conditions to minimize impurity formation. Impurities in Promethazine can arise from side reactions, incomplete reactions, or contaminants in the starting materials. Purification techniques such as filtration, recrystallization, or chromatography help remove these impurities and obtain a highly pure form of Promethazine.

Daicel Pharma provides a Certificate of Analysis (CoA) for Promethazine impurity standards, which include Promethazine EP Impurity A and Promethazine sulfoxide impurity. Our CoA from a cGMP-certified analytical laboratory includes thorough characterization data, including 1H NMR, 13C NMR, IR, MASS, and HPLC purity². On request, we give more characterization details, such as those for 13C-DEPT. At Daicel Pharma, our team of experts specializes in offering Promethazine impurities and labeled compounds for evaluating the effectiveness of generic Promethazine. Additionally, Daicel Pharma offers Promethazine Labelled Standard, a deuterium-labeled Promethazine R&S isomer D6 compounds, crucial for bioanalytical research and Bioavailability/Bioequivalence (BA/BE) research.