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Zinc sulfate | CAS No: 7733-02-0 | GMP-certified suppliers
A medication that addresses zinc deficiency and supports treatment of acute diarrhea, wound healing, and supplementation in parenteral nutrition through essential mineral supplementation and topical use.
Therapeutic categories
Primary indications
- This medication is a mineral used to treat or prevent low levels of zinc alone and together with oral rehydration therapy (ORT)
- It is also used as a topical astringent
- Zinc Sulfate Injection, USP is indicated for use as a supplement to intravenous solutions given for TPN
Product Snapshot
- Zinc sulfate is available in multiple formulation types including oral tablets, syrups, capsules, topical ointments, solutions, and intravenous injections
- It is primarily used as a mineral supplement to prevent or treat zinc deficiency and as a topical astringent, including use in parenteral nutrition
- Zinc sulfate products are approved for use in the US and Canada, with some formulations holding FDA approval and others in investigational stages
Clinical Overview
Clinically, zinc sulfate is primarily indicated for the treatment and prevention of zinc deficiency, both as a standalone mineral supplement and adjunctively with oral rehydration therapy (ORT) in managing acute diarrhea. It is also used topically as an astringent. The injectable form is available for supplementation in parenteral nutrition regimens, specifically total parenteral nutrition (TPN), where intravenous zinc replenishment is necessary.
Pharmacodynamically, zinc serves as a cofactor for more than 70 enzymes, including alkaline phosphatase, lactic dehydrogenase, and both RNA and DNA polymerases, facilitating various biological functions such as wound healing, maintaining normal growth, skin hydration, and sensory functions like taste and smell.
The mechanism of action of zinc sulfate in reducing fluid loss during diarrheal illness involves the inhibition of cyclic AMP-induced, chloride-dependent fluid secretion. This is achieved by zinc’s selective blockade of basolateral potassium channels in the intestinal epithelium, thereby reducing chloride secretion and fluid loss. Additionally, zinc enhances water and electrolyte absorption, promotes intestinal epithelial regeneration, increases brush border enzyme levels, and supports immune function, improving pathogen clearance.
Pharmacokinetic data on zinc are limited in the literature; however, as a divalent cation, zinc absorption primarily occurs in the small intestine, with homeostatic mechanisms regulating systemic zinc levels.
Safety considerations for zinc sulfate include potential gastrointestinal irritation when administered orally and careful monitoring of dosing to avoid zinc toxicity, which can interfere with copper metabolism and cause adverse systemic effects.
From a sourcing perspective, zinc sulfate APIs should comply with pharmacopeial standards such as USP or EP, ensuring suitable purity, microbial limits, and heavy metal content. Reliable suppliers should provide certificates of analysis and demonstrate consistent quality to support pharmaceutical manufacturing and regulatory compliance.
Identification & chemistry
| Generic name | Zinc sulfate |
|---|---|
| Molecule type | Small molecule |
| CAS | 7733-02-0 |
| UNII | 0J6Z13X3WO |
| DrugBank ID | DB09322 |
Pharmacology
| Summary | Zinc acts primarily by inhibiting cAMP-activated basolateral potassium channels, reducing chloride-dependent fluid secretion in the intestine. It also enhances water and electrolyte absorption, supports intestinal epithelial regeneration, and modulates immune function to aid pathogen clearance. Additionally, zinc serves as a cofactor for numerous enzymes involved in cellular repair and metabolic processes. |
|---|---|
| Mechanism of action | Zinc inhibits cAMP-induced, chloride-dependent fluid secretion by inhibiting basolateral potassium (K) channels, in in-vitro studies with rat ileum. This study has also shown the specificity of Zn to cAMP-activated K channels, because zinc did not block the calcium (Ca)-mediated K channels. As this study was not performed in Zn-deficient animals, it provides evidence that Zn is probably effective in the absence of Zn deficiency. Zinc also improves the absorption of water and electrolytes, improves regeneration of the intestinal epithelium, increases the levels of brush border enzymes, and enhances the immune response, allowing for a better clearance of the pathogens. |
| Pharmacodynamics | Zinc has been identified as a cofactor for over 70 different enzymes, including alkaline phosphatase, lactic dehydrogenase and both RNA and DNA polymerase. Zinc facilitates wound healing, helps maintain normal growth rates, normal skin hydration and the senses of taste and smell. |
ADME / PK
| Absorption | Approximately 20 to 30% of dietary zinc is absorbed, primarily from the duodenum and ileum. The amount absorbed is dependent on the bioavailability from food. Zinc is the most bioavailable from red meat and oysters. Phytates may impair absorption by chelation and formation of insoluble complexes at an alkaline pH. After absorption, zinc is bound in the intestine to the protein metallothionein. Endogenous zinc can be reabsorbed in the ileum and colon, creating an enteropancreatic circulation of zinc. |
|---|---|
| Half-life | 3 hours |
| Protein binding | Zinc is 60% bound to albumin; 30 to 40% bound to alpha-2 macroglobulin or transferrin; and 1% bound to amino acids, primarily histidine and cysteine. |
| Route of elimination | Primarily fecal (approximately 90%); to a lesser extent in the urine and in perspiration. |
| Volume of distribution | After absorption zinc is bound to protein metallothionein in the intestines. Zinc is widely distributed throughout the body. It is primarily stored in RBCs, WBCs, muscles, bones, Skin, Kidneys, Liver, Pancreas, retina, and prostate. |
Formulation & handling
- Zinc sulfate is a small molecule suitable for multiple administration routes including oral, topical, ophthalmic, intravenous, and rectal formulations.
- Optimal oral absorption requires administration on an empty stomach and avoidance of milk, dairy products, bran, and high-fiber foods within a 2-hour window before and after dosing.
- Handle with standard precautions for inorganic compounds, paying attention to formulation stability in aqueous solutions due to potential interactions with excipients.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) has patent protection expired in both the US and Canada, allowing for generic competition. As a result, the API is considered to be in a mature market phase within these regions. |
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| Markets | Canada, US |
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Supply Chain
| Supply chain summary | The zinc sulfate supply landscape features several originator companies producing branded products primarily available in the US and Canada markets. Multiple branded formulations exist, including allergy and symptom relief drops, indicating established market presence. Lack of explicit patent data suggests existing generic competition is likely present or impending. |
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Safety
| Toxicity | Human : TDLo ( Oral) 45mg/kg/7D-C : Normocytic anemia, pulse rate increase without fall inBP Human: TDLo (oral) 106mg/kg : Hypermotylity, diarrhea Mouse ; LD50 Oral : 245mg/kg Mouse : LD50 : subcutaneous : 781mg/kg |
|---|
- Oral exposure at doses ≥45 mg/kg over 7 days may induce normocytic anemia and increased pulse rate without hypotension
- Higher oral doses (~106 mg/kg) have been associated with gastrointestinal effects such as hypermotility and diarrhea
- Acute toxicity in animal models shows LD50 values of 245 mg/kg orally and 781 mg/kg subcutaneously in mice
Zinc sulfate 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.
Zinc sulfate API manufacturers & distributors
Compare qualified Zinc sulfate API suppliers worldwide. We currently have 4 companies offering Zinc sulfate 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 |
|---|---|---|---|---|---|
| Acta minerals | Producer | Netherlands | Netherlands | BSE/TSE, CoA, GMP, MSDS | 67 products |
| Anmol Chemicals | Producer | India | India | CoA | 7 products |
| DNS Fine Chemicals | Producer | India | India | CoA | 8 products |
| Global Pharma Tek | Distributor | India | India | BSE/TSE, CoA, FDA, GMP, ISO9001, MSDS | 484 products |
When sending a request, specify which Zinc sulfate 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 Zinc sulfate 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.
