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Copper | CAS No: 7440-50-8 | GMP-certified suppliers
A medication that provides essential micronutrient supplementation in parenteral nutrition and serves as a contraceptive component in copper-containing intrauterine devices.
Therapeutic categories
Primary indications
- For use in the supplementation of total parenteral nutrition and in contraception with intrauterine devices
Product Snapshot
- Copper is available in multiple formulation types including injectable solutions, oral tablets and capsules, and intrauterine devices
- It is primarily used for supplementation in total parenteral nutrition and as a contraceptive in intrauterine devices
- Copper products are approved and marketed in the US and Canadian regulatory environments
Clinical Overview
Clinically, copper is used both as a nutritional supplement in total parenteral nutrition and as the active component in copper-containing intrauterine devices (IUDs) for contraception. The contraceptive mechanism is attributed to copper ions released locally, which reduce sperm viability and motility, thereby decreasing the likelihood of fertilization and embryonic implantation. The precise molecular pathways mediating these effects remain incompletely defined.
Pharmacodynamically, copper is absorbed through the gastrointestinal tract predominantly via high affinity copper uptake proteins and also through other transporters including low affinity copper uptake proteins and natural resistance-associated macrophage protein-2. After reduction to the Cu1+ state, intracellular copper is transported by the protein ATOX1 to copper-transporting ATPases within the Golgi apparatus. Systemically, copper binds mainly to ceruloplasmin (65-90%), albumin (around 18%), and alpha 2-macroglobulin (approximately 12%). These binding proteins facilitate copper’s distribution and maintenance in plasma.
From a safety perspective, copper deficiency can manifest in rare genetic disorders such as Menke’s disease and Occipital Horn Syndrome, both characterized by defective connective tissue development and, in Menke’s disease, progressive neurodegeneration. Excessive copper exposure carries risk of toxicity, necessitating careful control of dosage, especially in parenteral formulations.
Notable for its widespread physiological roles and use in medical devices, copper's specification during API procurement should prioritize purity, absence of contaminants, and compliance with relevant pharmacopoeial standards to ensure safety and efficacy in end-use applications. Quality assurance includes verification of particle size, oxidation state, and batch-to-batch consistency to meet regulatory and clinical requirements.
Identification & chemistry
| Generic name | Copper |
|---|---|
| Molecule type | Small molecule |
| CAS | 7440-50-8 |
| UNII | 789U1901C5 |
| DrugBank ID | DB09130 |
Pharmacology
| Summary | Copper functions as an essential trace element incorporated as a cofactor into numerous enzymes involved in oxidative stress response and connective tissue development. It is absorbed via specialized intestinal transport proteins and distributed systemically bound primarily to ceruloplasmin. Therapeutically, copper is supplemented in parenteral nutrition and exerts contraceptive effects through localized reduction of sperm viability when released from copper-containing intrauterine devices. |
|---|---|
| Mechanism of action | Copper is absorbed from the gut via high affinity copper uptake protein and likely through low affinity copper uptake protein and natural resistance-associated macrophage protein-2 . It is believed that copper is reduced to the Cu1+ form prior to transport. Once inside the enterocyte, it is bound to copper transport protein ATOX1 which shuttles the ion to copper transporting ATPase-1 on the golgi membrane which take up copper into the golgi apparatus. Once copper has been secreted by enterocytes into the systemic circulation it remain largely bound by ceruloplasmin (65-90%), albumin (18%), and alpha 2-macroglobulin (12%). Copper is an essential element in the body and is incorporated into many oxidase enzymes as a cofactor . It is also a component of zinc/copper super oxide dismutase, giving it an anti-oxidant role. Copper defiency occurs in Occipital Horn Syndrome and Menke's disease both of which are associated with impaired development of connective tissue due to the lack of copper to act as a cofactor in protein-lysine-6-oxidase. Menke's disease is also associated with progressive neurological impairment leading to death in infancy. The precise mechanisms of the effects of copper deficiency are vague due to the wide range of enzymes which use the ion as a cofactor. Copper appears to reduce the viabilty and motility of spermatozoa . This reduces the likelihood of fertilization with a copper IUD, producing copper's contraceptive effect . The exact mechanism of copper's effect on sperm are unknown. |
| Pharmacodynamics | Copper is incorporated into many enzymes throughout the body as an essential part of their function . Copper ions are known to reduce fertility when released from copper-containing IUDs . |
Targets
| Target | Organism | Actions |
|---|---|---|
| Amyloid beta A4 protein | Humans | binder |
| Adenosylhomocysteinase | Humans | allosteric modulator |
| Histone H2B type 1-C/E/F/G/I | Humans |
ADME / PK
| Absorption | Copper absorption varies inversely with intake. Absorption range is 12-65%. |
|---|---|
| Protein binding | Copper is nearly entirely bound by ceruloplasmin (65-90%), plasma albumin (18%), and alpha 2-macroglobulin (12%) . |
| Route of elimination | Copper appears to be eliminated primarily through bile . |
Formulation & handling
- Copper is a small molecule inorganic compound formulated for oral, intravenous, topical, and intrauterine routes.
- Due to its extremely low water solubility, specialized formulation strategies are necessary for injectable and oral solution forms.
- Handling should consider its solid state and metal nature, with stability dependent on minimizing exposure to moisture and potential oxidation.
Regulatory status
| Lifecycle | The API’s primary patents have expired in both the US and Canada, allowing for generic manufacturing and distribution. As a result, the market in these regions has reached a mature phase with multiple approved generic products available. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | The manufacturing and supply landscape for Copper includes multiple originator companies producing branded products primarily distributed in the US and Canadian markets. The portfolio features a range of multivitamins and specialty formulations with established presence in North America. Patent expirations for several products indicate the potential for existing or forthcoming generic competition in these therapeutic categories. |
|---|
Safety
| Toxicity | Copper toxicity is belevied to be due to fenton-type redox reactions occuring with high copper concentrations which produce damaging reactive oxygen species . |
|---|
- Potential for oxidative stress due to Fenton-type redox reactions at elevated copper concentrations
- Handle with appropriate protective equipment to minimize exposure and avoid inhalation or ingestion
- Ensure controlled dosing to prevent accumulation and toxicity during formulation and manufacturing processes
Food & Drug Administration approved
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. FDA is important because it is intended to have companies produce their goods to certain standards and it presents this fact in a clear overview using FDA certificates. When a company is (US) FDA approved, it shows the American government has declared the API or medicine as safe and it can be sold, imported, or used in the United States. The USA is not the only country with a regulatory agency like FDA. Most other countries have agencies that are responsible for the national safety of pharmaceutical products. Some different kinds of organizations include:
EMA (European Medicines Agency, European Union)
MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom)
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
CDSCO (Central Drugs Standard Control Organization, India)
Copper is a type of Minerals and electrolytes
Pharmaceutical API category Minerals and Electrolytes refers to a group of essential nutrients that are crucial for maintaining proper bodily functions. These minerals and electrolytes play a vital role in various physiological processes such as nerve signaling, muscle contraction, and fluid balance. They are often used as active ingredients in pharmaceutical formulations to address deficiencies or imbalances in the body.
Common minerals and electrolytes found in this API category include calcium, magnesium, potassium, sodium, and chloride. Calcium is necessary for healthy bones and teeth, while magnesium supports enzyme function and energy production. Potassium and sodium are electrolytes that help regulate fluid balance and nerve impulses, while chloride is involved in maintaining proper pH levels.
Pharmaceutical companies utilize these minerals and electrolytes in the production of medications, including oral tablets, powders, and intravenous solutions. These formulations are used to treat various conditions such as electrolyte imbalances, dehydration, and certain cardiovascular disorders.
The Minerals and Electrolytes API category is significant in the pharmaceutical industry as it provides healthcare professionals with essential ingredients to develop effective treatments for patients. By incorporating these minerals and electrolytes into pharmaceutical formulations, healthcare providers can address deficiencies and restore the proper balance of these vital nutrients in the body. Overall, the Minerals and Electrolytes API category is essential for maintaining optimal health and well-being.
Copper API manufacturers & distributors
Compare qualified Copper API suppliers worldwide. We currently have 2 companies offering Copper API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| Jost Chemical | Producer | United States | United States | CoA | 14 products |
| Ruibang Laboraties | Producer | China | China | CoA, FDA, GMP | 10 products |
When sending a request, specify which Copper 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.).
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