Description

Diphenhydramine Citrate is the citrate salt form of the well-known antihistamine, diphenhydramine. This compound is valued for its enhanced stability and solubility profile compared to the free base, making it a preferred active pharmaceutical ingredient (API) in specific formulations. It is primarily utilized by pharmaceutical manufacturers in the development and production of solid and liquid dosage forms, particularly where improved handling and formulation characteristics are required.

Application

• Pharmaceutical API: Core active ingredient in over-the-counter (OTC) and prescription sleep aids and antihistamine medications.
• Solid Dosage Forms: Used in the manufacturing of tablets and capsules designed for the temporary relief of sleeplessness and allergy symptoms.
• Liquid Formulations: Suitable for oral solutions and syrups, benefiting from the salt's solubility.
• Motion Sickness Remedies: A key component in formulations aimed at preventing and treating nausea, vomiting, and dizziness associated with motion sickness.
• Veterinary Pharmaceuticals: Employed in certain veterinary medicinal products for its sedative and antiemetic properties.
• Research & Development: Serves as a chemical reference standard and intermediate in pharmacological and pharmacokinetic studies.

Basic Information

Product Name	Diphenhydramine Citrate
CAS No.	88637-37-0
Molecular Formula	C21H27NO · C6H8O7
Molecular Weight	447.48 g/mol
Synonyms	2-(Diphenylmethoxy)-N,N-dimethylethylamine citrate; Diphenhydramine hydrogen citrate; 1-Phenyl-1-(2-pyridyl)-3-dimethylaminopropane citrate; Benzhydramine citrate; Benadryl citrate; Allerdryl citrate; DPH citrate
EINECS	Contact for details

Quality Control

Our Diphenhydramine Citrate is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets high-purity standards suitable for pharmaceutical applications. A Certificate of Analysis (COA) detailing purity, identity, and impurity profiles is provided with every shipment. We can support compliance with various pharmacopeial standards, including USP and EP, upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry, and well-ventilated area at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed to prevent absorption of atmospheric moisture.

Specification

Item	Specification
Appearance	White or almost white crystalline powder
Identification (IR)	Conforms
Identification (HPLC)	Conforms
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%, Total impurities ≤ 1.5%

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