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Sucrose | CAS No: 57-50-1 | GMP-certified suppliers
A medication that serves primarily as a sweetening and bulking excipient to enhance palatability and stability in oral formulations across diverse pharmaceutical products.
Therapeutic categories
Product Snapshot
- Oral solid and liquid formulations include tablets, chewable tablets, and solutions
- It is used mainly as a carbohydrate source or excipient in pharmaceutical preparations and for rapid energy or glucose support functions
- It is available in the US with approved, experimental, and investigational regulatory statuses depending on the specific application
Clinical Overview
The primary pharmacologic relevance of sucrose relates to its role as a dietary carbohydrate and energy substrate rather than as an active therapeutic molecule. In the gastrointestinal tract, sucrose is rapidly hydrolyzed by the brush-border enzyme sucrase into glucose and fructose. These monosaccharides are absorbed via sodium-dependent and facilitated transport pathways. Intact sucrose has negligible systemic exposure because enzymatic hydrolysis precedes absorption.
Mechanistic effects are limited to its metabolic contribution. Glucose enters glycolytic and oxidative pathways, while fructose is primarily metabolized in the liver. The caloric load and rate of monosaccharide generation can influence glycemic and metabolic responses, which is relevant in patients with diabetes mellitus or hereditary fructose intolerance.
Sucrose is generally recognized as safe at typical dietary and excipient levels. Excessive intake is associated with dental caries and may contribute to metabolic disorders when consumed in high quantities. Parenteral administration is uncommon, but when used in specialized formulations, osmotic load must be considered. Hypersensitivity reactions to sucrose itself are rare, though impurities are a potential concern depending on source and processing.
Sucrose appears in numerous commercial oral and pediatric formulations as an excipient rather than an API, where it provides palatability, viscosity, and stability.
For API or excipient procurement, suppliers should provide evidence of plant origin, refinement method, microbiological control, and compliance with major pharmacopeial monographs such as USP, EP, or JP. Control of particle size, moisture content, and residual inorganic impurities is important for consistent performance in finished formulations.
Identification & chemistry
| Generic name | Sucrose |
|---|---|
| Molecule type | Small molecule |
| CAS | 57-50-1 |
| UNII | C151H8M554 |
| DrugBank ID | DB02772 |
Pharmacology
Targets
| Target | Organism | Actions |
|---|---|---|
| Taste receptor type 1 member 2 | Humans | |
| Beta-lactamase | Escherichia coli (strain K12) | |
| Lysozyme C | Humans |
Formulation & handling
- High aqueous solubility and solid-state stability allow straightforward incorporation into oral solutions and chewable tablet matrices.
- Highly hydrophilic profile (low LogP) supports rapid dissolution in oral formats without need for solubilizers.
- Non‑reactive small‑molecule sugar; generally stable under standard manufacturing conditions but hygroscopicity should be monitored to prevent caking.
Regulatory status
| Lifecycle | In the US market, the API’s lifecycle stage is primarily determined by its patent and exclusivity status. Once these protections expire, the product typically transitions to a mature phase characterized by generic competition. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Sucrose‑containing anti‑nausea and multivitamin products in the United States are supplied by several branded OTC manufacturers rather than a single originator, reflecting long‑established use of the ingredient. These products are commercially available only in the US market, with no distinct EU or broader international branded presence indicated. Sucrose is an older, non‑patented substance, so generic and multi‑source supply is already fully established. |
|---|
Sucrose is a type of Sweeteners
Sweeteners are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the pharmaceutical industry to enhance the palatability of medicinal products. These additives provide a pleasant taste while maintaining the desired therapeutic properties of the drug formulation.
Pharmaceutical sweeteners are primarily employed to mask the inherent bitterness or unpleasant flavors of certain medications, making them more appealing to patients, particularly children and individuals with taste sensitivities. These sweeteners are carefully selected to meet specific criteria such as safety, stability, and compatibility with other ingredients in the formulation.
There are various types of sweeteners used in pharmaceuticals, including artificial sweeteners, natural sweeteners, and sugar alcohols. Artificial sweeteners such as aspartame, sucralose, and saccharin are non-nutritive compounds that provide intense sweetness without contributing significant calories. Natural sweeteners like stevia extract and monk fruit extract are derived from plant sources and offer a more natural alternative.
In addition to their taste-enhancing properties, pharmaceutical sweeteners must adhere to stringent regulatory guidelines to ensure patient safety. Extensive testing is conducted to evaluate their toxicity, purity, and compatibility with other pharmaceutical ingredients. Furthermore, the stability of sweeteners in different storage conditions is assessed to guarantee their effectiveness over the product's shelf life.
Overall, pharmaceutical sweeteners play a crucial role in improving patient compliance and acceptability of medicinal products. Their careful selection and formulation contribute to the development of palatable and effective medications, ultimately enhancing the overall therapeutic experience for patients.
Sucrose (Sweeteners), classified under Additives
Additives in the pharmaceutical API category refer to a group of chemical substances that are incorporated into pharmaceutical products to enhance their stability, functionality, or performance. These additives play a crucial role in ensuring the quality, safety, and efficacy of medications.
One common type of additive used in pharmaceuticals is preservatives. Preservatives are added to prevent microbial growth and maintain the integrity of the product throughout its shelf life. They help to safeguard against contamination and maintain the potency of the active pharmaceutical ingredient (API). Some commonly used preservatives include benzyl alcohol, phenol, and parabens.
Another important group of additives is antioxidants. Antioxidants are added to pharmaceutical formulations to prevent or delay the oxidation of APIs, which can lead to degradation and loss of potency. Examples of antioxidants commonly used in pharmaceuticals include ascorbic acid (vitamin C) and tocopherols (vitamin E).
In addition to preservatives and antioxidants, other additives like flavorings, colorants, and sweeteners may be incorporated into pharmaceutical products to improve their palatability and patient acceptability.
It is crucial to note that the use of additives in pharmaceuticals is strictly regulated by health authorities to ensure their safety and efficacy. Manufacturers must comply with stringent quality control standards and guidelines to guarantee the proper use and appropriate levels of additives in pharmaceutical products.
Overall, additives play a vital role in the pharmaceutical industry by enhancing the stability, functionality, and patient acceptability of medications. Their careful selection and incorporation contribute to the overall quality and effectiveness of pharmaceutical products.
Sucrose API manufacturers & distributors
Compare qualified Sucrose API suppliers worldwide. We currently have 4 companies offering Sucrose 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 |
|---|---|---|---|---|---|
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Chr. Olesen Group | Distributor | Denmark | China | CoA, USDMF | 252 products |
| Fujifilm Wako Pure Chemic... | Producer | Japan | Japan | BSE/TSE, CoA, GMP, ISO9001, MSDS | 55 products |
| Tereos | Producer | France | France | CoA, Other, GMP, Other, ISO9001 | 6 products |
When sending a request, specify which Sucrose 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 Sucrose 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 Sucrose API
Sourcing
What matters most when sourcing GMP-grade Sucrose?
Which documents are typically required when sourcing Sucrose API?
Which manufacturers are known to produce Sucrose API?
How can I request quotes for Sucrose API from GMP suppliers?
Is a GMP audit report available for Sucrose manufacturers?
How many suppliers offer Sucrose API on Pharmaoffer?
Which countries are known to manufacture Sucrose API?
Which certifications do suppliers of Sucrose usually hold?
Technical
What is Sucrose (CAS 57-50-1) used for?
Which therapeutic class does Sucrose fall into?
What should someone know about the safety or toxicity profile of Sucrose?
What are important formulation and handling considerations for Sucrose as an API?
Is Sucrose a small molecule?
Are there special stability concerns for oral Sucrose?
Regulatory
Where is Sucrose approved or in use globally?
What’s the regulatory and patent landscape for Sucrose right now?
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Sucrose procurement?
Is Sucrose included in the PRO Data Insights coverage?
Where can I access the API market report for Sucrose?
