Brimonidine Impurities and Brimonidine
Daicel Pharma is a reliable source for synthesizing high-quality Brimonidine impurities, specifically 5-Bromo-6-isothiocyanato quinoxaline, Brimonidine Carbamothioate Impurity, Brimonidine Cyclic Impurity, Brimonidine Impurity-A, B, C, D, E, & H, Brimonidine Unknown Impurity I, Brimonidine Unknown Impurity II, and O-Isopropyl(5-Bromoquinoxalin-6-yl)Carbamothioate. These impurities play a crucial role in assessing the quality, stability, and safety of the active pharmaceutical ingredient, Brimonidine. Daicel Pharma also offers custom synthesis of Brimonidine impurities, which can be shipped worldwide.
Brimonidine [CAS: 59803-98-4] is a medicine to treat open-angle glaucoma or ocular hypertension. It is an imidazole derivative and selectively activates alpha-2 adrenergic receptors in the eye. Brimonidine is also a quinoxaline derivative and a secondary amine. It is known to have antihypertensive properties and acts as an adrenergic agonist, specifically an alpha-adrenergic agonist.
Brimonidine: Use and Commercial Availability
Brimonidine administration is as eye drops to treat open-angle glaucoma or ocular hypertension, either alone or in combination with brinzolamide. It reduces intraocular pressure through the selective activation of alpha-2 adrenergic receptors. Additionally, it treats persistent facial erythema of rosacea in adults. Brimonidine is available under various brand names, including Alphagan, Combigan, Lumify, Mirvaso, Qoliana, Simbrinza, etc.
Brimonidine Structure and Mechanism of Action
The chemical name of Brimonidine is 5-Bromo-N-(4,5-dihydro-1H-imidazol-2-yl)-6-quinoxalinamine. Its chemical formula is C11H10BrN5, and its molecular weight is approximately 292.13 g/mol.
Brimonidine acts as an agonist at alpha-2 adrenoceptors and lowers intraocular pressure. It causes the blood vessels to narrow, reducing the aqueous humor production and increasing its outflow leading to a reduction in intraocular pressure.
Brimonidine Impurities and Synthesis
During the synthesis1 of Brimonidine, impurities may form, which can affect drug safety and efficacy. Therefore, it is necessary to identify and control the impurities to ensure the quality of the final product. The impurities form due to various factors such as contaminants in the starting materials, process impurities, and degradation products. Manufacturers must monitor and control them during the entire manufacturing process and establish appropriate specifications to ensure the safety and efficacy of the drug.
Daicel Pharma issues a Certificate of Analysis (CoA) for Brimonidine impurity standards, including 5-Bromo-6-isothiocyanato quinoxaline, Brimonidine Carbamothioate Impurity, Brimonidine Cyclic Impurity, Brimonidine Impurity-A, B, C, D, E, & H, Brimonidine Unknown Impurity I, Brimonidine Unknown Impurity II and O-Isopropyl(5-Bromoquinoxalin-6-yl)Carbamothioate. The CoA is from an analytical facility that complies with current Good Manufacturing Practices (cGMP) and includes comprehensive characterization data, such as 1H NMR, 13C NMR, IR, MASS2, and HPLC purity. We give additional characterization data such as 13C-DEPT and CHN on request. Daicel Pharma can prepare unknown Brimonidine impurities or degradation products. A complete characterization report accompanies each delivery.
- Thomas, Michael Barrie; Williams, Michael Trevelyan, Process For The Production Of Imidazolines, Pfizer Inc., Panama, GB1463520A, February 2, 1977
- Acheampong, Andrew; Tang-Liu, Diane D. S, Measurement of brimonidine concentrations in human plasma by a highly sensitive gas chromatography/mass spectrometric assay, Journal of Pharmaceutical and Biomedical Analysis, Volume: 13, Issue: 8, Pages: 995-1002, 1995
Frequently Asked Questions
How often should Brimonidine impurities be monitored?
Brimonidine impurities monitoring should be throughout the drug development process, including during the synthesis and storage of the drug product. Further, impurities need monitoring during stability studies and after any changes to the manufacturing process.
What are the risks of Brimonidine impurities?
The risks of Brimonidine impurities can include decreased efficacy, increased toxicity, and harm to patients' safety and health.
Do Brimonidine impurities affect the bioavailability of the drug?
Impurities in Brimonidine affect the drug bioavailability by interfering with drug absorption or metabolism, leading to decreased efficacy or toxicity.
How are impurities in Brimonidine detected?
Impurities in Brimonidine are detected through various analytical techniques, such as HPLC and LC-MS.
What are the temperature conditions required to store Brimonidine impurities?
Brimonidine impurities are stored at a controlled room temperature between 2-8 ⁰C or as indicated on the Certificate of Analysis (CoA).
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