99% Tofacitinib Citrate API Of GMP Factory
Tofacitinib is an oral Janus Kinase (JAK) inhibitor that disrupts the JAK-STAT signaling pathway, a key mediator of immune response and inflammation.
Our Tofacitinib Citrate API is manufactured in ICH Q7 GMP-certified facilities and supported by a comprehensive regulatory dossier (US FDA-registered and audited). It is the critical building block for developing advanced therapies targeting rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
We empower you to navigate complex bioequivalence studies and stringent pharmacy compounding standards with absolute confidence.
Why Choose Us As Your Tofacitinib API Supplier
#1. Fast shipment:
We have over 5 kg of Tofacitinib API as running stock for fast shipment. Contact us for quick orders; we will ship them out within 2~5 days.
#2. Guaranteed quality:
100% refund if the quality does not meet our purity requirements.
Our steady manufacturing process consistently maintains high yields and impurity levels below limits.
#3. Low MOQ:
Our MOQ is 100G but is Subject To Negotiation.
#4. The highest purity you can ever find:
Our purity standard is 99.5% or higher.
Tofacitinib Citrate API Applications and Specifications
Therapeutic Applications of Tofacitinib Citrate
Rheumatoid Arthritis (RA): Providing an effective oral alternative or adjunct to biologic DMARDs.
Psoriatic Arthritis (PsA): Addressing both joint inflammation and skin manifestations.
Ulcerative Colitis (UC): Offering induction and maintenance therapy for moderate to severe cases.
Compounding Applications: Enabling personalized dosage forms for patients with specific needs, such as custom oral suspensions or topical formulations.
Product Name: Tofacitinib Citrate APIs (枸橼酸托法替尼/枸橼酸托法昔布)
Appearance: A white powder
Solubility: insoluble in water and ethanol but very soluble in DMSO and DMF (N, N-dimethylacetamide)
Cas Number: 540737-29-9
Molecular Formula: C16H20N6O • C6H8O7
Molecular Weight: 504.5 g/mol
Chemical Name: 2-hydroxypropane-1,2,3-tricarboxylic acid;3-[(3R,4R)-4-methyl-3-[methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino]piperidin-1-yl]-3-oxopropanenitrile
HS Code: 2933599099 (Other compounds with a pyrimidine ring in their structure-其他结构上有嘧啶环等的化合物)
Suitability to be shipped by air as common goods: suitable. It is safe to be shipped by air as common goods.
Grade: Pharma-Grade/Chemical Grade
Purity or Assay: 99%
Standards: Current Enterprise Standards
Certificates available: ISO/GMP
Documents Available: COA/DMF/MSDS
Supply Capability: 50+ KG per month
MOQ: 100G
Lead Time: 3~5 days for quantities less than 5KG, 3~4 days for orders less than 500 g.
Stock Status: Over 5KG
Shipping Temperature: Room temperature
Storage: 2~8 °C
Technical Data:
Related substances: Isomer: NMT0.1%, single impurity: NMT0.1%, Total impurities: NMT0.5%
Water: NMT1.0%
Residue on ignition: NMT0.1%
Heavy metals: NMT20ppm
Assay: 98.0%~102.0%
FAQs About Our Tofacitinib Citrate API
Q1: What is Tofacitinib Citrate API used for?
A: It’s a JAK1/2/3 inhibitor for autoimmune diseases like rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. The mechanism involves blocking cytokine signaling pathways.
Q2: Is your API compliant with international regulations?
A: Yes. cGMP-certified with DMFs filed in the US, EU, and Japan.
Q3: What forms do you offer?
A: 99% bulk Tofacitinib Citrate API with GMP, no finished formulations available.
Q4: Minimum order quantity (MOQ)?
A: 0.1 kg for standard orders; flexible for long-term contracts. Bulk discounts apply.
Q5: Lead time for bulk orders?
A: 3–5 days for APIs in stock; 2–5 weeks for custom batches.
Q6: How is the API stored and shipped?
A: Stored at Room Temperature; shipped via air, sea, or courier (DHL, FedEx).
Q7: What are the risks of drug interactions?
A: Avoid CYP3A4 inhibitors (e.g., ketoconazole) and biologics (e.g., TNF inhibitors) due to additive immunosuppression.
Q8: Can I compound Tofacitinib into specialized formulations?
A: Yes. Compatible with polymers like HPMC for extended-release capsules. Stability validated for 6 months.
Q9: Is your tofacitinib API sterile?
A: Currently, our API is only non-sterile.
Other Small Molecules You May Like
