Procainamide HCl Clinical Trials

Size	Price	Qty
50mg	USD 147
200mg	USD 270

Clinical Trials

A completed, unphased clinical trial evaluated procainamide hydrochloride to investigate ST-segment elevation as a potential electrocardiographic endophenotype for atrial fibrillation susceptibility. Sponsored by Vanderbilt University Medical Center in collaboration with the National Heart, Lung, and Blood Institute, the study highlights the compound's utility in identifying electrophysiological markers for cardiac arrhythmias.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01205529	Completed	Atrial Fibrillation	Vanderbilt University Medical Center\|National Heart Lung and Blood Institute (NHLBI)	2010-11	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Procainamide HCl product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Procainamide HCl selectively binds to voltage-gated sodium channels and inhibits DNA methyltransferase, thereby blocking rapid sodium influx across cardiac cellular membranes. This block slows conduction velocity and prolongs refractory periods in myocardial tissues, effectively suppressing abnormal automaticity and reentrant electrical circuits involved in atrial fibrillation.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).