Multiple clinical trials evaluate the clinical applications and management protocols associated with succinylcholine chloride dihydrate, primarily investigating neuromuscular blockade, suxamethonium sensitivity, gastric content aspiration, drug onset timing during rapid sequence induction, and neuromuscular monitoring strategies. Featuring completed or unknown recruitment statuses across unassigned or non-applicable phases, these studies are sponsored by academic medical centers and industry organizations, including University Hospital Caen, Herlev Hospital, and Merck Sharp & Dohme LLC.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03415607 | Unknown status | Suxamethonium Sensitivity|Aspiration of Gastric Contents Into Respiratory Tract Part Unspecified |
University Hospital Caen |
2017-11-06 | -- |
| NCT02925143 | Completed | Neuromuscular Blockade |
Herlev Hospital|Merck Sharp & Dohme LLC |
2016-11-21 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
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>).
- Succinylcholine Chloride Dihydrate Solubility in DMSO
- Succinylcholine Chloride Dihydrate Stock Solution
- Succinylcholine Chloride Dihydrate Storage
- Succinylcholine Chloride Dihydrate Stability
- Succinylcholine Chloride Dihydrate Molecular Weight
- Succinylcholine Chloride Dihydrate SMILES
- Succinylcholine Chloride Dihydrate CAS Number
- Succinylcholine Chloride Dihydrate Chemical Structure (2D and 3D)
- Succinylcholine Chloride Dihydrate SDS|MSDS