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Ascorbic acid | CAS No: 50-81-7 | GMP-certified suppliers
A medication that addresses vitamin C deficiency and scurvy while supporting wound and bone healing and providing antioxidant benefits for diverse clinical and nutritional needs.
Therapeutic categories
Primary indications
- Used to treat vitamin C deficiency, scurvy, delayed wound and bone healing, urine acidification, and in general as an antioxidant
- It has also been suggested to be an effective antiviral agent
Product Snapshot
- Ascorbic acid is supplied as an oral small‑molecule vitamin product and in various parenteral solutions for injectable use
- It is used for vitamin C supplementation addressing deficiency states and associated metabolic or healing support needs
- It is marketed as an approved drug and nutraceutical in the US and Canada
Clinical Overview
Pharmacologically, ascorbic acid is a water‑soluble reducing agent and coenzyme involved in multiple metabolic pathways. Deficiency leads to impaired collagen synthesis, resulting in lesions in vascular and skeletal tissues; appropriate supplementation reverses these manifestations. Its antioxidant activity derives from the ability of ascorbic acid and its reversible oxidation product, dehydroascorbic acid, to participate in redox cycling.
The mechanism of action centers on its role as a cofactor for enzymes responsible for the posttranslational hydroxylation of proline residues in collagen. This function underpins tissue repair and structural stability. Additional biochemical roles include participation in tyrosine metabolism, the conversion of folic acid to folinic acid, carbohydrate metabolism, synthesis of certain lipids and proteins, facilitation of non‑heme iron absorption, and support of immune defense and cellular respiration processes.
As a water‑soluble vitamin, ascorbic acid is readily absorbed in the small intestine through sodium‑dependent transporters, with bioavailability decreasing at higher oral doses due to saturable uptake. It is widely distributed, with higher concentrations in adrenal glands, pituitary tissue, and leukocytes. Excess amounts are eliminated renally. Toxicity is low, though very high intakes may cause gastrointestinal discomfort or contribute to oxalate burden in susceptible individuals.
Common usage contexts include oral nutritional supplementation and parenteral administration when deficiency is severe. Notable formulations are available globally as generic vitamin C products.
For API procurement, key considerations include control of oxidative degradation, confirmation of stereochemical identity, validated residual solvent limits, and adherence to pharmacopeial specifications to ensure consistent potency and stability.
Identification & chemistry
| Generic name | Ascorbic acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 50-81-7 |
| UNII | PQ6CK8PD0R |
| DrugBank ID | DB00126 |
Pharmacology
| Summary | Ascorbic acid functions as a redox‑active cofactor for multiple iron‑ and 2‑oxoglutarate–dependent dioxygenases, supporting collagen maturation and other hydroxylation reactions central to tissue integrity and metabolic pathways. Its reversible interconversion with dehydroascorbic acid underpins broad roles in oxidative–reductive processes, including those involved in amino acid, lipid, and carbohydrate metabolism. Major pharmacodynamic effects reflect restoration of normal collagen structure and cellular functions in states of vitamin C deficiency. |
|---|---|
| Mechanism of action | In humans, an exogenous source of ascorbic acid is required for collagen formation and tissue repair by acting as a cofactor in the posttranslational formation of 4-hydroxyproline in -Xaa-Pro-Gly- sequences in collagens and other proteins. Ascorbic acid is reversibly oxidized to dehydroascorbic acid in the body. These two forms of the vitamin are believed to be important in oxidation-reduction reactions. The vitamin is involved in tyrosine metabolism, conversion of folic acid to folinic acid, carbohydrate metabolism, synthesis of lipids and proteins, iron metabolism, resistance to infections, and cellular respiration. |
| Pharmacodynamics | Ascorbic Acid (vitamin C) is a water-soluble vitamin indicated for the prevention and treatment of scurvy, as ascorbic acid deficiency results in scurvy. Collagenous structures are primarily affected, and lesions develop in bones and blood vessels. Administration of ascorbic acid completely reverses the symptoms of ascorbic acid deficiency. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Hyaluronate lyase | Streptococcus pneumoniae serotype 4 (strain ATCC BAA-334 / TIGR4) | inhibitor |
| DNA | Humans | cleavage |
| Xylose isomerase | Streptomyces rubiginosus | substrate |
ADME / PK
| Absorption | 70% to 90% |
|---|---|
| Half-life | 16 days (3.4 hours in people who have excess levels of vitamin C) |
| Protein binding | 25% |
| Metabolism | Hepatic. Ascorbic acid is reversibly oxidised (by removal of the hydrogen from the enediol group of ascorbic acid) to dehydroascorbic acid. The two forms found in body fluids are physiologically active. Some ascorbic acid is metabolized to inactive compounds including ascorbic acid-2-sulfate and oxalic acid. |
Formulation & handling
- Highly water‑soluble small molecule suitable for oral and parenteral formulations, with rapid dissolution supporting syrups, solutions, and effervescent forms.
- Oxidation‑prone and sensitive to multivalent ions and reducible elemental species, requiring protection from air, metals, and light in both solid and solution formulations.
- Aqueous injectable solutions need pH control and antioxidant‑minimizing handling to prevent degradation during preparation and storage.
Regulatory status
| Lifecycle | The API shows mixed patent coverage in the United States, with key protections expiring in 2024 while additional patents extend exclusivity into 2032–2033, indicating a staggered transition toward generic entry. With commercialization limited to the US and Canada, market maturity will likely progress as early patents lapse and remaining protections wind down. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Ascorbic acid has no single originator driving global supply; instead, it is produced and distributed by numerous manufacturers and repackagers, indicating a mature and highly decentralized market. Branded and combination multivitamin products are widely available in the US and Canada, reflecting broad commercial use rather than reliance on a proprietary brand. While the core molecule is long off‑patent, the presence of US patents extending into 2032–2033 for specific formulations or processes suggests that most competition is already generic, with limited protected niches remaining. |
|---|
Certificate of Analysis
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
Ascorbic acid is a type of Vitamins
Vitamins are an essential subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a crucial role in maintaining optimal health and well-being. These organic compounds are required in small quantities by the human body to support various metabolic processes and ensure proper functioning of bodily systems. Vitamins can be broadly classified into two groups: fat-soluble vitamins (such as vitamins A, D, E, and K) and water-soluble vitamins (including vitamin C and B-complex vitamins). Each vitamin has a specific role and function within the body.
Pharmaceutical APIs in the vitamin subcategory are carefully synthesized or extracted to meet stringent quality standards and ensure purity, efficacy, and safety. They are used as active ingredients in the formulation of various pharmaceutical products, including dietary supplements, fortified foods, and pharmaceutical formulations.
Vitamin APIs are commonly utilized in the pharmaceutical industry for their therapeutic benefits. For instance, vitamin D API is widely prescribed to treat deficiencies and maintain optimal bone health, while vitamin C API is utilized for its antioxidant properties and immune-boosting effects. B-complex vitamins, such as vitamin B12 API, are essential for energy production and nerve function.
Overall, vitamins are integral to maintaining good health, and pharmaceutical APIs in this subcategory play a vital role in providing these essential nutrients to individuals through various pharmaceutical and dietary applications.
Ascorbic acid (Vitamins), classified under Therapeutic Nutrients/Minerals/Electrolyte
Therapeutic Nutrients/Minerals/Electrolytes: A Comprehensive Technical DescriptionTherapeutic nutrients, minerals, and electrolytes are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used to support and enhance overall health and well-being. These compounds play a crucial role in maintaining the body's physiological balance, aiding in various metabolic processes, and addressing specific deficiencies.
Therapeutic nutrients encompass a broad range of substances, including vitamins, minerals, and electrolytes. Vitamins are organic compounds required in small quantities for proper bodily functions and are essential for growth, development, and disease prevention. Minerals, on the other hand, are inorganic substances that support numerous physiological processes, such as bone formation, nerve function, and energy production.
Electrolytes are minerals that carry an electric charge when dissolved in bodily fluids, including sodium, potassium, calcium, magnesium, and chloride. They play a crucial role in maintaining proper hydration, nerve impulses, muscle contractions, and pH balance.
Pharmaceutical APIs in the Therapeutic Nutrients/Minerals/Electrolyte category are designed to address specific deficiencies or imbalances in the body. These APIs are often used in the formulation of dietary supplements, nutritional products, and therapeutic treatments. They are manufactured under stringent quality control guidelines to ensure purity, potency, and bioavailability.
Therapeutic nutrients/minerals/electrolytes APIs are available in various forms, including tablets, capsules, powders, and liquid formulations. They are formulated to meet specific dosage requirements and can be combined with other ingredients for targeted health benefits.
Overall, therapeutic nutrients, minerals, and electrolytes APIs are essential components in maintaining optimal health. Their use helps address deficiencies, support bodily functions, and promote overall well-being. Pharmaceutical companies and healthcare professionals rely on these high-quality APIs to develop effective and safe products that contribute to a healthier population.
Ascorbic acid API manufacturers & distributors
Compare qualified Ascorbic acid API suppliers worldwide. We currently have 12 companies offering Ascorbic acid API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| AMARI TRADE ALLIANEC LLP | Distributor | India | India | CoA | 15 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GDP, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC, WHO-GMP | 176 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC | 250 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Chemizo Enterprise | Distributor | India | India | CoA | 19 products |
| Chr. Olesen Group | Distributor | Denmark | China | CEP, CoA, USDMF | 252 products |
| Duchefa Farma B.V. | Distributor | Netherlands | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, WC | 170 products |
| Indukern Chemie AG | Distributor | Switzerland | Unknown | CoA | 13 products |
| Northeast Pharma | Producer | China | China | CoA, JDMF, WC | 5 products |
| Shandong Luwei | Producer | China | China | CoA, WC | 1 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, USDMF | 757 products |
| Takeda Pharma | Producer | Japan | Japan | CoA, JDMF | 8 products |
When sending a request, specify which Ascorbic acid 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 Ascorbic acid 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.
Frequently asked questions about Ascorbic acid API
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Technical
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Regulatory
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Pharmaoffer
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