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Baricitinib API Powder
Baricitinib API Powder: Uses, Specifications, Applications, and Buyers
SEO Title: Baricitinib API Powder: Uses, Specifications, Applications & Buyers
Meta Description: Learn what baricitinib API powder is, its pharmaceutical uses, chemical specifications, JAK1/JAK2 mechanism, applications, and who typically purchases this active pharmaceutical ingredient.
Primary Keyword: baricitinib API powder
Related Keywords: baricitinib API, baricitinib active pharmaceutical ingredient, baricitinib powder, CAS 1187594-09-7, baricitinib raw material, baricitinib pharmaceutical API, JAK1 JAK2 inhibitor, pharmaceutical-grade baricitinib
What Is Baricitinib API Powder?
Baricitinib API powder is the active pharmaceutical ingredient (API) form of baricitinib, a selective and reversible Janus kinase (JAK) inhibitor. The compound is particularly associated with inhibition of JAK1 and JAK2, enzymes involved in intracellular signaling pathways that regulate inflammation and immune-system activity.
Baricitinib is also known by the development codes LY3009104 and INCB028050 and is marketed as Olumiant in several markets. Its chemical identity is C₁₆H₁₇N₇O₂S, with a molecular weight of approximately 371.42 g/mol and CAS Registry Number 1187594-09-7.
In API terminology, the powder is not the finished medicine. It is the active substance that can be used by qualified pharmaceutical manufacturers as a starting material for producing an appropriate finished dosage form, subject to applicable regulatory requirements, quality specifications, and manufacturing controls.
The European Medicines Agency describes baricitinib drug substance as a white to practically white to light-pink powder. The EMA assessment also reports that the substance is practically insoluble in water and identifies a specific crystalline form selected for commercial development.
Baricitinib Chemical Identity
The principal chemical information for baricitinib includes:
| Specification | Details |
|---|---|
| Product name | Baricitinib |
| API type | Active Pharmaceutical Ingredient |
| CAS Number | 1187594-09-7 |
| Molecular Formula | C₁₆H₁₇N₇O₂S |
| Molecular Weight | 371.42 g/mol |
| Drug class | Janus kinase (JAK) inhibitor |
| Primary molecular targets | JAK1 and JAK2 |
| Development codes | LY3009104, INCB028050 |
| Appearance | White to practically white to light-pink powder |
| Stereochemistry | Non-chiral/achiral |
| Pharmaceutical route of finished product | Oral |
| Commercial brand | Olumiant |
| PubChem CID | 44205240 |
The chemical identity and molecular weight are documented by FDA and PubChem sources, while the physical description and solid-state information are reported in the EMA assessment documentation.
What Is Baricitinib Used For?
Baricitinib works by modulating the JAK-STAT signaling pathway. JAK enzymes transmit signals from certain cytokines and growth factors into cells. By inhibiting JAK1 and JAK2 activity, baricitinib can reduce signaling associated with inflammatory and immune responses.
The approved uses vary somewhat between regulatory jurisdictions, so pharmaceutical businesses should always refer to the current regulatory information applicable to their target market.
Rheumatoid Arthritis
Baricitinib is used in the management of moderate-to-severe rheumatoid arthritis (RA) in specified patients. In the current U.S. labeling, Olumiant is indicated for adults with moderately to severely active RA who have had an inadequate response to one or more TNF blockers.
In the European Union, the EMA describes baricitinib as an option for adults with moderate-to-severe active rheumatoid arthritis when previous disease-modifying antirheumatic drug treatment has not worked adequately or cannot be tolerated.
Alopecia Areata and Dermatological Applications
Another important application is severe alopecia areata, an autoimmune condition associated with hair loss. Current U.S. labeling includes severe alopecia areata in adults, while European authorization includes severe alopecia areata in adults and adolescents from 12 years of age.
The EMA also lists moderate-to-severe atopic dermatitis among authorized uses in the European Union, including specified pediatric patients, demonstrating that regulatory indications can differ according to jurisdiction.
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COVID-19 Treatment
Baricitinib also has a regulatory role in COVID-19 treatment in the United States. The current U.S. labeling indicates its use for hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Its COVID-19 use should not be confused with general antiviral products. Baricitinib is a JAK inhibitor that modifies inflammatory signaling rather than directly functioning as a conventional antiviral agent. The FDA’s original authorization and subsequent labeling provide the relevant clinical and regulatory context.
How Does Baricitinib API Work?
Baricitinib is considered a selective JAK inhibitor with activity primarily against JAK1 and JAK2. JAK proteins participate in signaling triggered by cytokines and growth factors. Once activated, they can influence STAT proteins and downstream gene expression.
By partially inhibiting JAK1/JAK2 enzymatic activity, baricitinib can reduce signaling through pathways associated with inflammatory cytokines. This mechanism is relevant to its use in immune-mediated diseases such as rheumatoid arthritis, alopecia areata, and atopic dermatitis.
From an API-development perspective, this mechanism is important because the identity and purity of the active substance need to be controlled carefully. Pharmaceutical manufacturers generally evaluate parameters such as identity, assay, related substances, residual solvents, water content, solid-state characteristics, and microbiological quality according to the intended product and applicable quality standards.
Pharmaceutical Quality Considerations
For baricitinib API powder, quality documentation is often as important as the chemical identity itself. Commercial pharmaceutical development may require appropriate analytical methods, impurity controls, batch-to-batch consistency, and documentation supporting the intended regulatory pathway.
The Australian regulatory assessment, for example, notes controls for residual solvents and discusses impurity specifications for baricitinib drug substance.
A typical technical specification sheet may therefore include:
| Quality Parameter | Typical Documentation/Requirement |
|---|---|
| Appearance | White to practically white/light-pink powder |
| Identification | Confirmed using validated analytical techniques |
| Assay | Manufacturer-defined pharmaceutical specification |
| Related substances | Controlled according to applicable specification |
| Residual solvents | Controlled according to applicable ICH requirements |
| Water content | Controlled according to product specification |
| Solid-state form | Controlled where relevant |
| Heavy metals/elemental impurities | Controlled according to applicable requirements |
| Microbiological quality | Based on intended pharmaceutical use |
| Packaging | Suitable pharmaceutical-grade protective packaging |
| Certificate of Analysis | Batch-specific CoA |
| Regulatory documentation | Dependent on market and intended use |
These should be regarded as specification categories rather than universal release limits. Actual acceptance criteria depend on the manufacturer, manufacturing process, dosage form, regulatory filing, and applicable pharmacopoeial or ICH requirements.
Who Buys Baricitinib API Powder?
Baricitinib API powder is primarily relevant to professional pharmaceutical and scientific organizations, rather than ordinary consumers. Because baricitinib is a prescription medicine and the API is a controlled pharmaceutical raw material in many supply chains, purchasing and handling should be performed within the appropriate legal and quality framework.
Pharmaceutical Manufacturers
Finished-dose pharmaceutical manufacturers may purchase baricitinib API as the active substance used in manufacturing approved or developmental dosage forms. Their requirements can include:
- Defined API purity and assay
- Consistent batch quality
- Certificate of Analysis (CoA)
- Analytical documentation
- Impurity profile
- Residual-solvent information
- Stability information
- Appropriate packaging
- Traceability and batch documentation
- Regulatory-supporting documentation
The finished product itself may be manufactured as tablets or other approved oral dosage presentations depending on the market and product development program.
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Contract Development and Manufacturing Organizations
CDMOs and pharmaceutical development companies may also work with baricitinib API for formulation development, analytical development, process development, stability programs, or commercial manufacturing activities.
These organizations typically require much more than a chemical sample. They may need complete technical packages covering analytical methods, specifications, impurity information, stability data, and manufacturing controls.
Research and Development Laboratories
Qualified pharmaceutical R&D laboratories, universities, biotechnology companies, and contract research organizations may use baricitinib as a research compound when investigating JAK signaling, inflammatory pathways, immune-mediated diseases, or potential new applications.
However, research-grade material should not automatically be treated as equivalent to pharmaceutical-grade API. Intended use, quality requirements, regulatory status, and documentation can differ substantially.
What Should Buyers Check When Evaluating Baricitinib API?
Organizations evaluating a baricitinib API supplier should focus on quality and regulatory documentation rather than chemical name alone.
Important considerations include:
- Identity confirmation — CAS number, molecular formula, analytical identification and traceability.
- Assay and purity — Results should be supported by appropriate validated analytical methods.
- Related substances — Impurities should be characterized and controlled according to the applicable specification.
- Residual solvents — Appropriate testing and limits should be documented.
- Solid-state characteristics — Crystal form can be important for pharmaceutical development.
- Batch consistency — Multiple batches should demonstrate reproducible quality.
- Certificate of Analysis — A batch-specific CoA should accompany pharmaceutical material.
- Stability data — Relevant stability information should be available for the intended storage conditions.
- Manufacturing controls — Buyers should assess the quality system and regulatory status appropriate to the intended application.
- Documentation — The required regulatory and technical package depends on the destination market and product-development stage.
The EMA’s assessment of baricitinib specifically discusses characterization of the active substance, including analytical techniques such as mass spectrometry, FTIR, Raman spectroscopy, UV spectroscopy, NMR, DSC, X-ray crystallography, and elemental analysis.
Baricitinib API Powder: Important Safety and Regulatory Considerations
Baricitinib is a pharmacologically active JAK inhibitor and should not be treated as an ordinary laboratory chemical or nutritional ingredient. Finished baricitinib products carry significant safety warnings. The current U.S. labeling includes warnings concerning serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
Consequently, API handling, formulation, testing, storage, and use should be performed by appropriately qualified organizations following applicable occupational, pharmaceutical, and regulatory requirements.
It is also important to distinguish API powder from finished baricitinib medicine. API powder is an active raw material; it is not intended for self-medication, direct human consumption, or informal preparation of tablets.
Conclusion
Baricitinib API powder is the pharmaceutical active ingredient corresponding to baricitinib, a selective JAK1/JAK2 inhibitor with established applications in immune-mediated and inflammatory diseases. Its chemical identity is CAS 1187594-09-7, molecular formula C₁₆H₁₇N₇O₂S, and molecular weight approximately 371.42 g/mol.
Its regulatory applications vary by region. In the United States, current labeling covers specified uses in rheumatoid arthritis, severe alopecia areata, and hospitalized COVID-19, while the European Union authorization also includes atopic dermatitis and juvenile idiopathic arthritis.
For the B2B pharmaceutical market, the main potential buyers are pharmaceutical manufacturers, CDMOs, research organizations, analytical laboratories, and qualified distributors. For these buyers, the most important considerations are API identity, purity, impurity control, analytical documentation, batch consistency, stability, and regulatory compliance.
Authoritative References
- PubChem — Baricitinib chemical information and identifiers
- FDA / DailyMed — Current Olumiant (baricitinib) prescribing information
- European Medicines Agency — Olumiant EPAR
- FDA — Baricitinib clinical pharmacology review
