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D-Leucine | CAS No: 328-38-1 | GMP-certified suppliers
A medication that serves as an experimental compound for research in amino acid derivatives, requiring high stereochemical purity for development in metabolic and protein-related studies.
Product Snapshot
- D-Leucine is an oral small molecule formulation
- It is primarily investigated for its potential use in neuromodulation and metabolic regulation
- The compound is currently classified as experimental and has no approved status with major regulatory agencies
Clinical Overview
While leucine in its L-form is essential for protein synthesis and hemoglobin formation, the specific clinical indications, pharmacodynamics, and mechanism of action of D-leucine remain undefined in current scientific and regulatory literature. Its biological role and effects have not been extensively characterized, and it is thus regarded primarily as an experimental compound rather than an approved therapeutic agent.
From a pharmacokinetic perspective, there is limited data describing the absorption, distribution, metabolism, and excretion (ADME) properties of D-leucine in humans or preclinical models. Its stereochemistry suggests potential differences in metabolic processing compared to L-leucine, including differing enzymatic recognition and transport.
Safety and toxicity profiles for D-leucine have not been comprehensively documented. Given its experimental status, no established safety parameters or adverse effect data are available to support clinical use. Consequently, D-leucine is not recognized in standard drug formularies or treatment guidelines.
Notable brand names or pharmaceutical preparations containing D-leucine are not identified due to the absence of regulatory approval or commercialization.
For sourcing and quality control, D-leucine API procurement requires stringent assessment of stereochemical purity to distinguish it from the endogenous L-isomer. Analytical techniques such as chiral chromatography are essential to ensure consistent enantiomeric composition. Suppliers should provide detailed certificates of analysis confirming identity, purity, and compliance with applicable pharmaceutical grade standards. Maintaining batch-to-batch consistency in stereoisomeric content is critical for experimental reproducibility and downstream application development.
Identification & chemistry
| Generic name | D-Leucine |
|---|---|
| Molecule type | Small molecule |
| CAS | 328-38-1 |
| UNII | 965COD96YA |
| DrugBank ID | DB01746 |
Formulation & handling
- D-Leucine is a small molecule amino acid derivative primarily suited for oral formulation due to high water solubility.
- Its low logP value indicates hydrophilicity, which may influence formulation strategies to enhance membrane permeability.
- As a stable solid compound, standard handling precautions for amino acid derivatives apply, with attention to moisture sensitivity.
Regulatory status
D-Leucine is a type of Other substances
The pharmaceutical industry encompasses a diverse range of active pharmaceutical ingredients (APIs) that are used in the production of various medications. One category of APIs is known as other substances. This category includes substances that do not fall under the conventional classifications such as antibiotics, analgesics, or antihypertensives.
Other substances in pharmaceutical APIs consist of a broad array of chemical compounds with unique properties and applications. These substances play a crucial role in the formulation and development of specialized medications, catering to specific therapeutic needs. The category encompasses various substances like excipients, solvents, stabilizers, and pH adjusters.
Excipients are inert substances that aid in the manufacturing process and enhance the stability, bioavailability, and patient acceptability of pharmaceutical formulations. Solvents are used to dissolve other ingredients and facilitate their incorporation into the final product. Stabilizers ensure the integrity and shelf life of medications by preventing degradation or chemical changes. pH adjusters help maintain the desired pH level of a formulation, which can influence the drug's efficacy and stability.
Pharmaceutical manufacturers carefully select and incorporate specific other substances into their formulations, adhering to regulatory guidelines and quality standards. These substances undergo rigorous testing and evaluation to ensure their safety, efficacy, and compatibility with the desired pharmaceutical product. By employing other substances in API formulations, pharmaceutical companies can optimize drug delivery, improve patient compliance, and enhance therapeutic outcomes.
In summary, the other substances category of pharmaceutical APIs comprises a diverse range of chemicals, including excipients, solvents, stabilizers, and pH adjusters. These substances contribute to the formulation, stability, and performance of medications, enabling pharmaceutical manufacturers to develop specialized products that meet specific therapeutic requirements.
D-Leucine API manufacturers & distributors
Compare qualified D-Leucine API suppliers worldwide. We currently have 1 companies offering D-Leucine API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| Wuhan Amino Acid Bio-Chem... | Producer | China | China | CoA | 32 products |
When sending a request, specify which D-Leucine 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 D-Leucine 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.
