CAS 65-28-1 Effective Pharmaceuticals Raw Materials Phentolamine Mesylate
Alias: VASOMAX;phentolaminemethanesulphonate; phentolamine methanesulfonate; Phentolamine methanesulfonate salt; phentolamine mesilate
EINECS Number: 200-604-6
Melting point: 180-182
Boiling point: 551 C at 760 mmHg
Flash Point: 287 C
Water-soluble: 50 mg / mL
Vapor Pressure: 9.48E-13mmHg at 25 C
Appearance: white powder
Phentolamine Mesylate (phentolamine mesylate) for Injection USP, is an antihypertensive, available in vials for intravenous and intramuscular administration. Each vial contains phentolamine mesylate (phentolamine mesylate) USP, 5 mg and mannitol USP, 25 mg in sterile, lyophilized form.
Phentolamine mesylate is m-[N-(2-Imidazolin-2-ylmethyl)-p-toluidino]phenol monomethanesulfonate (salt).
Phentolamine mesylate (phentolamine mesylate) USP is a white or off-white, odorless crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in alcohol, and slightly soluble in chloroform. It melts at about 178C.
Indications & Dosage
Phentolamine Mesylate (phentolamine mesylate) for Injection is indicated for the prevention or control of hypertensive episodes that may occur in a patient with pheochromocytoma as a result of stress or manipulation during preoperative preparation and surgical excision.
Phentolamine Mesylate (phentolamine mesylate) for Injection is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine.
Phentolamine Mesylate (phentolamine mesylate) for Injection is also indicated for the diagnosis of pheochromocytoma by the phentolamine blocking test.
Dosage AND Administration
The reconstituted solution should be used upon preparation and should not be stored.Prevention or control of hypertensive episodes in the patient with pheochromo-cytoma.For preoperative reduction of elevated blood pressure, 5 mg of phentolamine mesylate (phentolamine mesylate) (1 mg for children) is injected intravenously or intramuscularly 1 or 2 hours before surgery, and repeated if necessary.
During surgery, phentolamine mesylate (phentolamine mesylate) (5 mg for adults, 1 mg for children) is administered intravenously as indicated, to help prevent or control paroxysms of hypertension, tachycardia, respiratory depression, convulsions, or other effects of epinephrine intoxication. (Postoperatively, norepinephrine may be given to control the hypotension that commonly follows complete removal of a pheochromocytoma.
1). Phentolamine Mesylate is a nonselective alpha-adrenergic antagonist with IC50 of 0.1 M
An adrenergic blocking agent. An antihypertensive. Used for the treatment of pheochromocytoma.
2). Disorders of Sexual Function and Reproduction, Treatment of, ENDOCRINE DRUGS, RENAL-UROLOGIC DRUGS, Treatment of Erectile Dysfunction, Treatment of Female Sexual Dysfunction, Treatment of Male Sexual Dysfunction, alpha-Adrenoceptor Antagonists.
3). Phentolamine mesylate is safe and effective in the long-term treatment of men with mild to moderate ED. Phentolamine increased catecholamine release by presynaptic alpha 2-blockade, thereby suppressing the autoinhibition of transmitter release. Phentolamine leads to an increase in FBM by preferentially antagonizing presynaptic alpha 2-adrenoreceptors over postsynaptic alpha 1-adrenoreceptors. This influence of phentolamine on FBM may be secondary to its effect on ECoG. Promotion of LV-ECoG by catecholamines is mediated via an alpha 1-independent mechanism.
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Product name | Phentolamine mesilate |
CAS No. | 65-28-1 | Outer Packing | 1kg |
Production date | 2016.06.17 | Shelf life | 2018.06.16 |
Standard adopted | USP/32 |
Items of analysis | Specification | Results |
Appearance | White crystalline powder | Conforms |
Identification | Identification A IR, B UV,C
Identification A IR, B UV,C | Conforms |
Loss on drying | Not more than 0.5% | 0.25% |
Residue on ignition | Not more than 0.1% | 0.017%
Sulfate | Not more than 0.2% | 0.006% |
Chromatographic purit | Total: not more than 1.0% | 0.26% |
Chromatographic purit | Individual:not more than 0.5% | 0.17% |
Ethyl alcohol | Not more than 0.5% | 0.2%(G/G) |
Acetone | Not more than 0.5% | 0.17%(G/G) |
Assay | Between 98.0% to 102.0% 98.0~102.0% | 99.7% |
Conclusion | Qualified |
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Body Biological Co., Ltd. has been developing and producing high quality products under stric GMP conditions. Quality control and quality assurance are given high priority in order to meet international pharmacopoeia specifications and special customers requirements.
1. Method of Analysis for testing our materials are validated to give t