Edrophonium chloride Clinical Trials

Size	Price	Qty
5mg	USD 147

Clinical Trials

A clinical trial evaluating Edrophonium chloride focused on autonomic cardiovascular evaluation in individuals with spinal cord injury following neurotrauma. Sponsored by the James J. Peters Veterans Affairs Medical Center without an assigned formal clinical trial phase, this completed investigation targeted specialized physiological metrics. Overall, clinical evaluation of this compound remains focused on diagnostic cardiovascular metrics in specialized patient populations.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01758692	Completed	Spinal Cord Injury	James J. Peters Veterans Affairs Medical Center	2012-07	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Edrophonium chloride functions as a rapid-onset, readily reversible inhibitor of acetylcholinesterase, binding to the enzyme to prevent the hydrolytic degradation of acetylcholine within the synaptic cleft. The resulting accumulation of neurotransmitter potentiates post-synaptic cholinergic receptor signaling, enhancing neuromuscular and autonomic response for the assessment of cardiovascular integrity in patients with spinal cord injury.

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>).