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Isoleucine | CAS No: 73-32-5 | GMP-certified suppliers
A medication that supports management of hepatic encephalopathy and helps reduce catabolic decline, with exploratory use in movement disorders, for inclusion in nutritional and supplemental formulations.
Therapeutic categories
Amino AcidsAmino Acids, Branched-ChainAmino Acids, EssentialAmino Acids, Peptides, and ProteinsDietary SupplementsProteinogenic Amino Acids
Generic name
Isoleucine
Molecule type
small molecule
CAS number
73-32-5
DrugBank ID
DB00167
Approval status
Investigational drug, Nutraceutical drug
Primary indications
- The branched-chain amino acids may have antihepatic encephalopathy activity in some
- They may also have anticatabolic and antitardive dyskinesia activity
Product Snapshot
- Isoleucine is supplied as an oral and parenteral amino acid ingredient available in multiple solution, injection, emulsion, and solid formulations for use in compounded or blended nutrition products
- It is evaluated for anti‑hepatic‑encephalopathy, anticatabolic, and antitardive‑dyskinesia activity
- It is marketed as a nutraceutical and holds investigational status in the US and Canada
Clinical Overview
Isoleucine (CAS 73-32-5) is an essential branched‑chain amino acid required for protein synthesis and normal metabolic function. It is structurally related to leucine as a positional isomer and contributes to hemoglobin formation and maintenance of glucose and energy homeostasis. As a proteinogenic amino acid, it is incorporated into many endogenous proteins and participates in diverse cellular processes.
Clinically, branched‑chain amino acids, including isoleucine, have been investigated for potential roles in managing hepatic encephalopathy and for mitigating catabolic states. Limited exploratory reports also describe possible benefits in tardive dyskinesia, though evidence remains insufficient for definitive therapeutic positioning. Current use is largely within nutritional and supplemental contexts rather than established pharmacological treatment.
Isoleucine exerts its effects through participation in standard amino acid biochemistry and through its contribution to branched‑chain amino acid catabolism. BCAA metabolism begins in skeletal muscle, where a common BCAA aminotransferase converts each amino acid to its corresponding alpha‑keto acid. These intermediates are then processed by the branched‑chain alpha‑keto acid dehydrogenase complex, generating CoA derivatives that enter central energy pathways. Isoleucine degradation produces both acetyl‑CoA and propionyl‑CoA, supporting its classification as both glucogenic and ketogenic. The resultant NADH and FADH2 contribute to ATP generation.
ADME characteristics correspond to nutrient amino acids: efficient gastrointestinal absorption, distribution into systemic circulation and muscle tissue, metabolism through standard BCAA pathways, and renal elimination of minor metabolites. Safety considerations primarily relate to metabolic disorders involving impaired BCAA catabolism. Defects in branched‑chain alpha‑keto acid dehydrogenase lead to accumulation of BCAA‑derived keto acids, causing maple syrup urine disease, a severe inherited condition associated with neurological injury.
Isoleucine appears in various nutritional formulations and BCAA combinations. For API procurement, suppliers should provide documentation verifying amino acid identity, stereochemical purity, and compliance with compendial specifications, along with controls for residual solvents, elemental impurities, and microbiological quality appropriate to the intended use.
Clinically, branched‑chain amino acids, including isoleucine, have been investigated for potential roles in managing hepatic encephalopathy and for mitigating catabolic states. Limited exploratory reports also describe possible benefits in tardive dyskinesia, though evidence remains insufficient for definitive therapeutic positioning. Current use is largely within nutritional and supplemental contexts rather than established pharmacological treatment.
Isoleucine exerts its effects through participation in standard amino acid biochemistry and through its contribution to branched‑chain amino acid catabolism. BCAA metabolism begins in skeletal muscle, where a common BCAA aminotransferase converts each amino acid to its corresponding alpha‑keto acid. These intermediates are then processed by the branched‑chain alpha‑keto acid dehydrogenase complex, generating CoA derivatives that enter central energy pathways. Isoleucine degradation produces both acetyl‑CoA and propionyl‑CoA, supporting its classification as both glucogenic and ketogenic. The resultant NADH and FADH2 contribute to ATP generation.
ADME characteristics correspond to nutrient amino acids: efficient gastrointestinal absorption, distribution into systemic circulation and muscle tissue, metabolism through standard BCAA pathways, and renal elimination of minor metabolites. Safety considerations primarily relate to metabolic disorders involving impaired BCAA catabolism. Defects in branched‑chain alpha‑keto acid dehydrogenase lead to accumulation of BCAA‑derived keto acids, causing maple syrup urine disease, a severe inherited condition associated with neurological injury.
Isoleucine appears in various nutritional formulations and BCAA combinations. For API procurement, suppliers should provide documentation verifying amino acid identity, stereochemical purity, and compliance with compendial specifications, along with controls for residual solvents, elemental impurities, and microbiological quality appropriate to the intended use.
Identification & chemistry
| Generic name | Isoleucine |
|---|---|
| Molecule type | Small molecule |
| CAS | 73-32-5 |
| UNII | 04Y7590D77 |
| DrugBank ID | DB00167 |
Pharmacology
| Summary | Branched‑chain amino acids (valine, leucine, and isoleucine) serve as essential substrates for protein synthesis and energy metabolism, undergoing initial transamination and oxidative decarboxylation in muscle via shared aminotransferase and branched‑chain α‑keto acid dehydrogenase pathways. Their catabolic products feed into glucogenic or ketogenic routes, contributing to ATP generation and biosynthetic processes. Key targets include branched‑chain aminotransferases, branched‑chain–specific acyl‑CoA dehydrogenase, and isoleucyl‑tRNA ligases. |
|---|---|
| Mechanism of action | (Applies to Valine, Leucine and Isoleucine) This group of essential amino acids are identified as the branched-chain amino acids, BCAAs. Because this arrangement of carbon atoms cannot be made by humans, these amino acids are an essential element in the diet. The catabolism of all three compounds initiates in muscle and yields NADH and FADH2 which can be utilized for ATP generation. The catabolism of all three of these amino acids uses the same enzymes in the first two steps. The first step in each case is a transamination using a single BCAA aminotransferase, with a-ketoglutarate as amine acceptor. As a result, three different a-keto acids are produced and are oxidized using a common branched-chain a-keto acid dehydrogenase, yielding the three different CoA derivatives. Subsequently the metabolic pathways diverge, producing many intermediates. The principal product from valine is propionylCoA, the glucogenic precursor of succinyl-CoA. Isoleucine catabolism terminates with production of acetylCoA and propionylCoA; thus isoleucine is both glucogenic and ketogenic. Leucine gives rise to acetylCoA and acetoacetylCoA, and is thus classified as strictly ketogenic. There are a number of genetic diseases associated with faulty catabolism of the BCAAs. The most common defect is in the branched-chain a-keto acid dehydrogenase. Since there is only one dehydrogenase enzyme for all three amino acids, all three a-keto acids accumulate and are excreted in the urine. The disease is known as Maple syrup urine disease because of the characteristic odor of the urine in afflicted individuals. Mental retardation in these cases is extensive. Unfortunately, since these are essential amino acids, they cannot be heavily restricted in the diet; ultimately, the life of afflicted individuals is short and development is abnormal The main neurological problems are due to poor formation of myelin in the CNS. |
| Pharmacodynamics | They provide ingredients for the manufacturing of other essential biochemical components in the body, some of which are utilized for the production of energy, stimulants to the upper brain and helping you to be more alert. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Short/branched chain specific acyl-CoA dehydrogenase, mitochondrial | Humans | |
| Branched-chain-amino-acid aminotransferase, cytosolic | Humans | |
| Branched-chain-amino-acid aminotransferase, mitochondrial | Humans |
ADME / PK
| Absorption | Absorbed from the small intestine by a sodium-dependent active-transport process |
|---|---|
| Metabolism | Hepatic |
Formulation & handling
- Highly water‑soluble small‑molecule amino acid suitable for aqueous IV formulations, commonly incorporated into parenteral nutrition mixtures.
- Chemically stable under standard conditions, but IV solutions may require pH control to prevent precipitation when co‑mixed with other amino acids or electrolytes.
- Oral solid forms present minimal formulation challenges due to good solubility and lack of known food‑related absorption issues.
Regulatory status
| Lifecycle | Patent‑expiry information for this API is not provided, but in markets such as the US and Canada, lifecycle status is typically defined by loss of exclusivity and subsequent generic entry. Based on available details, additional patent timing would be required to characterize its market maturity accurately. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Branded isoleucine‑containing parenteral nutrition products are supplied mainly by a small number of originator and packager entities, with current distribution concentrated in the US and Canada. These formulations are well established globally as standard amino‑acid components of intravenous nutrition rather than patented innovations. Because isoleucine is a basic amino acid without active patent protection, the market typically consists of mature, non‑exclusive supply with existing generic competition. |
|---|
Safety
| Toxicity | Symptoms of hypoglycemia, increased mortality in ALS patients taking large doses of BCAAs |
|---|
High Level Warnings:
- High-dose exposure has been associated with hypoglycemia‑related neurological symptoms (e
- G
- , confusion, reduced consciousness), indicating a need to monitor for metabolic instability in research settings
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)
L-Isoleucine is a type of Amino acids
Amino acids are an essential category of pharmaceutical active pharmaceutical ingredients (APIs) widely used in the pharmaceutical industry. These organic compounds are the building blocks of proteins and play a crucial role in various biological processes. With their increasing popularity and therapeutic potential, amino acids have become a focus of research and development in drug discovery.
Amino acids can be classified into two main categories: essential and non-essential. Essential amino acids cannot be synthesized by the body and must be obtained from dietary sources or through pharmaceutical supplementation. Non-essential amino acids, on the other hand, can be synthesized by the body itself.
Pharmaceutical-grade amino acids are produced through a variety of methods, including extraction from natural sources, fermentation, and chemical synthesis. They undergo rigorous quality control procedures to ensure purity, efficacy, and safety. The most common amino acids used as APIs include lysine, valine, leucine, isoleucine, phenylalanine, and methionine, among others.
Amino acids have diverse applications in the pharmaceutical industry. They are widely used as ingredients in parenteral nutrition formulations, where they provide essential nutrients to patients who cannot consume food orally. Additionally, amino acids are utilized in the development of protein-based drugs, such as monoclonal antibodies and recombinant proteins. These pharmaceutical proteins often require specific amino acid sequences to achieve desired therapeutic effects.
In conclusion, amino acids are a vital category of pharmaceutical APIs, playing a significant role in protein synthesis, nutrition, and the development of protein-based drugs. With their extensive applications and growing demand, amino acids continue to contribute to advancements in the pharmaceutical industry.
L-Isoleucine API manufacturers & distributors
Compare qualified L-Isoleucine API suppliers worldwide. We currently have 9 companies offering L-Isoleucine API, with manufacturing taking place in 3 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 |
|---|---|---|---|---|---|
| Ajinomoto | Producer | Japan | Unknown | CEP, CoA, FDA, GMP, USDMF | 24 products |
| Amino GmbH | Producer | Germany | Unknown | CEP, CoA, FDA, GMP, USDMF | 17 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WC | 235 products |
| Evonik Rexim | Producer | China | China | CEP, CoA, FDA, GMP, WC | 18 products |
| Shanghai Kyowa A.A | Producer | China | Unknown | CEP, CoA, FDA, GMP | 12 products |
| Taenaka Kogyo | Producer | Japan | Japan | CoA, JDMF | 6 products |
| Tianjin Tianyao | Producer | China | China | CoA, WC | 24 products |
| Wuhan Amino Acid Bio-Chem... | Producer | China | China | CoA | 32 products |
| Wuxi Jinghai Amino Acid C... | Producer | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF, WC | 15 products |
When sending a request, specify which L-Isoleucine 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 L-Isoleucine 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 L-Isoleucine API
Sourcing
What matters most when sourcing GMP-grade L-Isoleucine?
Key considerations include confirming GMP compliance and meeting applicable US and Canadian regulatory requirements for parenteral‑grade amino acids. Supplier qualification is important because distribution of L-Isoleucine‑containing parenteral products is concentrated among a limited number of established manufacturers. Assessing supply reliability and documentation practices helps ensure consistent quality in a mature, non‑exclusive market with existing generic competition.
Which documents are typically required when sourcing L-Isoleucine API?
Request the core API documentation set: CoA (9 companies), GMP (6 companies), CEP (5 companies), FDA (4 companies), USDMF (4 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce L-Isoleucine API?
Known or reported manufacturers for L-Isoleucine: Changzhou Comwin Fine Chemicals Co., Ltd, Wuxi Jinghai Amino Acid Co., Ltd. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for L-Isoleucine API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for L-Isoleucine manufacturers?
Audit reports may be requested for L-Isoleucine: 3 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer L-Isoleucine API on Pharmaoffer?
Reported supplier count for L-Isoleucine: 9 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture L-Isoleucine API?
Production countries reported for L-Isoleucine: China (5 producers), Japan (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of L-Isoleucine usually hold?
Common certifications for L-Isoleucine suppliers: CoA (9 companies), GMP (6 companies), CEP (5 companies), FDA (4 companies), USDMF (4 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is L-Isoleucine (CAS 73-32-5) used for?
L-Isoleucine is used in nutritional formulations to support protein synthesis, hemoglobin formation, and normal glucose and energy metabolism. It is included in branched‑chain amino acid combinations and other dietary preparations. Clinically, BCAAs containing L-Isoleucine have been explored for hepatic encephalopathy and catabolic states, though established therapeutic use remains limited to nutritional contexts.
Which therapeutic class does L-Isoleucine fall into?
L-Isoleucine belongs to the following therapeutic categories: Amino Acids, Amino Acids, Branched-Chain, Amino Acids, Essential, Amino Acids, Peptides, and Proteins, Dietary Supplements. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is L-Isoleucine mainly prescribed for?
The primary indications for L-Isoleucine: The branched-chain amino acids may have antihepatic encephalopathy activity in some, They may also have anticatabolic and antitardive dyskinesia activity. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does L-Isoleucine work?
(Applies to Valine, Leucine and L-Isoleucine) This group of essential amino acids are identified as the branched-chain amino acids, BCAAs. Because this arrangement of carbon atoms cannot be made by humans, these amino acids are an essential element in the diet. The catabolism of all three compounds initiates in muscle and yields NADH and FADH2 which can be utilized for ATP generation. The catabolism of all three of these amino acids uses the same enzymes in the first two steps. The first step in each case is a transamination using a single BCAA aminotransferase, with a-ketoglutarate as amine acceptor. As a result, three different a-keto acids are produced and are oxidized using a common branched-chain a-keto acid dehydrogenase, yielding the three different CoA derivatives. Subsequently the metabolic pathways diverge, producing many intermediates. The principal product from valine is propionylCoA, the glucogenic precursor of succinyl-CoA. L-Isoleucine catabolism terminates with production of acetylCoA and propionylCoA; thus L-Isoleucine is both glucogenic and ketogenic. Leucine gives rise to acetylCoA and acetoacetylCoA, and is thus classified as strictly ketogenic. There are a number of genetic diseases associated with faulty catabolism of the BCAAs. The most common defect is in the branched-chain a-keto acid dehydrogenase. Since there is only one dehydrogenase enzyme for all three amino acids, all three a-keto acids accumulate and are excreted in the urine. The disease is known as Maple syrup urine disease because of the characteristic odor of the urine in afflicted individuals. Mental retardation in these cases is extensive. Unfortunately, since these are essential amino acids, they cannot be heavily restricted in the diet; ultimately, the life of afflicted individuals is short and development is abnormal The main neurological problems are due to poor formation of myelin in the CNS.
What should someone know about the safety or toxicity profile of L-Isoleucine?
L-Isoleucine is generally well tolerated as an essential amino acid, but high-dose exposure has been linked to hypoglycemia‑related neurological symptoms such as confusion and reduced consciousness, warranting metabolic monitoring in research settings. Individuals with impaired branched‑chain amino acid catabolism, including those with defects in the branched‑chain alpha‑keto acid dehydrogenase complex, may experience harmful accumulation of related metabolites. In such metabolic disorders, elevated BCAA‑derived keto acids can contribute to neurological injury.
What are important formulation and handling considerations for L-Isoleucine as an API?
L-Isoleucine is a highly water‑soluble amino acid that can be formulated in aqueous solutions, including IV preparations used in parenteral nutrition. It is chemically stable under standard conditions, but pH control may be necessary in IV mixtures to prevent precipitation when combined with other amino acids or electrolytes. Oral solid formulations are generally straightforward because of its good solubility and lack of known food‑related absorption issues. Proper handling should maintain standard storage conditions to preserve stability.
Is L-Isoleucine a small molecule?
L-Isoleucine is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral L-Isoleucine?
Oral L-Isoleucine is chemically stable under standard conditions and generally does not present notable stability issues. Its good water solubility supports straightforward solid‑dose formulation. No specific pH or co‑mixing concerns described for oral products.
Regulatory
Where is L-Isoleucine approved or in use globally?
L-Isoleucine is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for L-Isoleucine right now?
In Canada and the United States, L-Isoleucine is regulated within existing frameworks for amino acids used in food, supplements, and pharmaceutical applications. No specific patent or exclusivity constraints are indicated in the provided context.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with L-Isoleucine procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for L-Isoleucine. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is L-Isoleucine included in the PRO Data Insights coverage?
PRO Data Insights coverage for L-Isoleucine: 3979 verified transactions across 836 suppliers and 638 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for L-Isoleucine?
Market report availability for L-Isoleucine: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
