Rocuronium Bromide 119302-91-9

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Product Information

Product name	Rocuronium Bromide
CAS No.	119302-91-9
Molecular Formula	C₃₂H₅₃N₂O₄^.Br
Molecular Weight	609.69
Quality Standard	CEP,EP/USP
Appearance	White to off-white powder

COA

Test Items	Specifications	Results
Appearance	White to off-white powder	White powder
Identification	Infrared absorption	Conforms
	The retention time of rocuronium bromide peak of the sample solution corresponds to that of the standard solution	Conforms
	Identification test, bromide	Conforms
Assay (on anhydrous & solvent-free substances)	98.0% - 102.0%	99.9%
Specific Rotation	+28.5°~ +32.0°	+31.5°
pH	7.0 ~ 9.5	9.3
Residue on Ignition	≤0.1%	0.04%
Residual solvents	Impurity A ≤0.2%	0.01%
	Impurity B ≤0.3%	ND
	Impurity C ≤0.2%	0.04%
	Impurity D ≤0.1%	ND
	Impurity E ≤0.1%	ND
	Impurity F ≤0.1%	ND
	Impurity G ≤0.1%	ND
	Impurity H ≤0.1%	ND
	Any individual unspecified impurity ≤0.10%	ND
	Total impurities ≤1.5%	0.046%
Propanol	≤1.0%	ND
Acetic acid	≤5.0%	ND
Water content	≤4.0%	2.4%
Color and achromicity	The sample solution is not more intensely colored than the reference solution	Conforms
Bacterial endotoxin	Endotoxin amount per 1mg Rocuronium Bromide should be less than 0.3EU	Conforms
Microbial limits	Aerobic bacterial count should be ≤10² cfu/g	Conforms
	Yeast/Mold count should be ≤10² cfu/g	<10cfu/g
	Not detect Escherichia coli per 1g	<10cfu/g
	Total impurities ≤ 3.5%	ND
Storage	Keep in well-closed container below 25°C,in dark place
Conclusion	It conforms to all the USP-NF2024 quality standard.

Usage

Rocuronium Bromide: The Preferred Rapid-Onset Non-Depolarizing Neuromuscular Blocker

In modern anesthesia, stable and rapid muscle relaxation is critical for optimal intubation and surgical conditions. As a second-generation aminosteroidal non-depolarizing neuromuscular blocking agent (NMBA), Rocuronium Bromide has become an indispensable adjuvant in operating rooms worldwide, distinguished by its excellent pharmacokinetic profile and superior safety margin.

Core Clinical Advantages of Rocuronium Bromide

1. Rapid Onset for Critical Intubation Windows

The hallmark of Rocuronium is its swift onset of action. At the standard intubating dose of 0.6 mg/kg, excellent tracheal intubation conditions are typically achieved within 60 seconds. For scenarios requiring immediate sequence induction, higher doses further reduce onset time, establishing it as the premier alternative to Succinylcholine when contraindicated.

2. Hemodynamic Stability

Unlike earlier-generation myorelaxants, Rocuronium is associated with minimal histamine release. Within clinical dosing ranges, it exhibits negligible effects on heart rate and blood pressure. This cardiovascular stability makes it particularly suitable for geriatric populations and patients with compromised hemodynamic profiles.

3. Predictable Metabolism & Reversibility

Primarily eliminated via the hepatic/biliary pathway with renal excretion as a secondary route, Rocuronium features inactive metabolites. Its blockade is readily reversible using acetylcholinesterase inhibitors (e.g., Neostigmine) and can be specifically antagonized by Sugammadex, significantly enhancing postoperative recovery control and patient safety.

High-Purity Rocuronium Bromide API Manufacturing Excellence in China

We recognize that the complex stereochemistry of Rocuronium presents significant synthesis challenges. Our process utilizes a natural steroid precursor (Epiandrosterone) via a precisely controlled synthetic pathway.

Manufacturing Highlights:

1. Precision Stereochemical Control: Addressing the molecule’s 10 chiral centers, our optimized epoxidation and regioselective ring-opening technologies ensure high enantiomeric purity and robust control of related substances.

2. Superior Purity Profile: An advanced selective acetylation process resolves the challenge of 3α/17β-hydroxyl group differentiation, ensuring the final API consistently meets stringent USP/EP monograph requirements.

3. Reliable Global Supply: Backed by mature industrial-scale capacity and strict GMP compliance, we guarantee consistent batch-to-batch quality and a secure supply chain for global pharmaceutical partners.