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Tromethamine | CAS No: 77-86-1 | GMP-certified suppliers
A medication that prevents and corrects metabolic acidosis by acting as a buffering agent to stabilize blood pH and support electrolyte balance in intravenous and parenteral solutions.
Therapeutic categories
Primary indications
- For the prevention and correction of metabolic acidosis
Product Snapshot
- Tromethamine is available as injectable solutions and topical creams for parenteral and topical administration
- It is primarily used for the prevention and correction of metabolic acidosis
- The product is approved for use in the US and Canadian markets
Clinical Overview
Clinically, tromethamine is indicated for the prevention and correction of metabolic acidosis. It acts principally as a buffering agent, helping to neutralize excess acidity in the blood, thereby stabilizing physiological pH levels. While detailed pharmacodynamic and specific mechanism of action data are not specified, its utility as an alkalizing agent is based on its capacity to accept protons and maintain acid-base balance.
Pharmacokinetic parameters (absorption, distribution, metabolism, and excretion) for tromethamine are not extensively characterized in available data. Its primary use is as a functional excipient and buffer in intravenous solutions, enhancing electrolyte balance and serving as a key component in blood substitutes, perfusion solutions, and other parenteral formulations.
Safety and toxicity profiles indicate that tromethamine is generally well tolerated when used within appropriate dosing regimens. As an alkalizer, caution is necessary to avoid overcorrection of blood pH, which may lead to metabolic alkalosis. It is routinely employed in controlled clinical settings, emphasizing the need for careful monitoring.
Tromethamine also serves as an emulsifying agent in cosmetic and pharmaceutical formulations, including creams, lotions, and mineral oil or paraffin wax emulsions. Its chemical properties facilitate its role as a surface-active agent and biological buffer in diverse applications.
Notable pharmaceutical formulations utilize tromethamine as an intravenous additive and buffer, although specific branded products vary by region and formulation.
From an API procurement perspective, quality considerations include stringent control of purity, residual solvents, and microbial contamination. Compliance with pharmacopeial standards is essential, alongside validation of batch-to-batch consistency to ensure suitability for parenteral and topical pharmaceutical formulations.
Identification & chemistry
| Generic name | Tromethamine |
|---|---|
| Molecule type | Small molecule |
| CAS | 77-86-1 |
| UNII | 023C2WHX2V |
| DrugBank ID | DB03754 |
Pharmacology
Targets
| Target | Organism | Actions |
|---|---|---|
| Amyloid beta A4 protein | Humans | inhibitor |
Formulation & handling
- Tromethamine is a small molecule highly water-soluble with intravenous and topical formulations.
- Handling considerations include maintaining solution stability for parenteral administration.
- No known peptide or food interaction sensitivities are associated with Tromethamine.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is currently marketed in the US and Canada, with key patents expiring in the near term, indicating a transition from exclusive market protection to increased generic competition. Market maturity is expected to advance as patent barriers diminish. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Tromethamine includes a limited number of originator companies producing branded products primarily in the US and Canadian markets. The presence of branded formulations such as Sooryehan Hyo Fermented Sun Block and Tham indicates established market positioning in these regions. Patent expiry data suggests that generic competition may already be present or forthcoming, potentially increasing supply options in the near term. |
|---|
Trometamol is a type of Other cardiac agents
The category of other cardiac agents in the pharmaceutical API (Active Pharmaceutical Ingredient) industry encompasses a diverse range of substances that play a crucial role in cardiovascular health. These agents are designed to target specific mechanisms within the cardiovascular system to either treat or manage various cardiac conditions. While they may not fall under the more well-known categories such as beta blockers or calcium channel blockers, they are equally significant in addressing cardiovascular disorders.
One prominent example of an API in this category is ivabradine, which acts as a selective inhibitor of the If current in the sinoatrial node. This unique mechanism allows it to reduce heart rate without affecting other cardiovascular parameters, making it particularly useful in managing stable angina or chronic heart failure.
Another notable API in this category is ranolazine, which exhibits a multi-modal mechanism of action involving inhibition of late sodium channels, resulting in improved myocardial ischemia and decreased angina episodes. It is commonly used in patients with chronic angina who have not adequately responded to other antianginal agents.
Furthermore, agents like trimetazidine, which possesses anti-ischemic and metabolic properties, and molsidomine, a nitric oxide donor, contribute to the category's diversity. They offer additional treatment options for angina and other related cardiac disorders.
The inclusion of these agents in the other cardiac agents category underscores the continuous efforts to develop novel pharmaceutical APIs that address specific cardiovascular conditions. Their distinct mechanisms of action provide healthcare professionals with a broader spectrum of therapeutic options for managing heart-related diseases.
C58
Trometamol API manufacturers & distributors
Compare qualified Trometamol API suppliers worldwide. We currently have 6 companies offering Trometamol API, with manufacturing taking place in 6 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Duchefa Farma B.V. | Distributor | Netherlands | United Kingdom | CoA, GMP, ISO9001, MSDS | 170 products |
| Fujifilm Wako Pure Chemic... | Producer | Japan | Japan | BSE/TSE, CoA, GMP, ISO9001, MSDS | 55 products |
| Hopax Fine Chemicals | Producer | Taiwan | Taiwan | CoA, ISO9001 | 16 products |
| Hänseler AG | Distributor | Switzerland | Switzerland | CoA, GMP, MSDS | 174 products |
| Pharmacia & Upjohn | Producer | United States | Ireland | CoA, GMP | 30 products |
When sending a request, specify which Trometamol API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Trometamol API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
