Guanidine HCl Clinical Trials

Size	Price	Qty
50mg	USD 97

Clinical Trials

A completed observational clinical trial sponsored by Centre Hospitalier le Mans evaluated conditions associated with guanidine administration, focusing on intensive care unit patients in France with botulism and general poisoning. As a retrospective epidemiological study, no formal clinical trial phase was assigned to the protocol. Ultimately, this research provides key clinical insights regarding the characterization and management of botulism poisoning within critical care settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03658902	Completed	Botulism; Poisoning	Centre Hospitalier le Mans	2000-01-01	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Guanidine HCl acts as a chaotropic agent and neuromuscular stimulant that enhances presynaptic calcium influx, thereby promoting the quantal release of acetylcholine into the neuromuscular synaptic cleft. This elevated acetylcholine availability restores cholinergic transmission at the motor endplate, providing functional counteraction of muscle paralysis in clinical conditions such as botulism poisoning.

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>).