99% up Tofacitinib Citrate 540737-29-9

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:99% up Tofacitinib Citrate 540737-29-9
CAS No.:540737-29-9
Standard:USP, BP, EP, JP, In-house Standards
Price(USD):Negotiable
Company:Sinoway Industrial Co.Ltd.

Basic Info
  • Grade: Pharmaceutical Grade

    Factory Location: Xiamen, Fujian

    Main Sales Markets: North America,Central/South America,Western Europe,Eastern Europe,Australasia,Asia,Middle East

  • Monthly Production Capacity: 1000kg

    Packaging Information: 25kg/drum 1kg/bottle

  • Delivery Lead Time: 7 days after payment

    Sample Provided: yes

    Payment Terms: L/L

    Product Information

     

    Product name

    Tofacitinib Citrate

    CAS No.

    540737-29-9

    Molecular Formula

    C16H20N6O.C6H8O7

    Molecular Weight

    504.5

    Quality Standard

    99% up, Medicine Grade

    Appearance

    White powder

     

    COA of Tofacitinib Citrate

     

    Item

    Specification

    Result

    Appearance

    White crystalline powder

    Complies

    Related substance (HPLC)

    Total impurity ≤0.5%

    Max single impurity ≤0.1%

    0.2%

    0.06%

    Odor

    Characteristic

    Complies

    Assay

    99%

    99.8%

    Sieve analysis

    100% pass 80 mesh

    Complies

    Loss on Drying

    Residue on Ignition

    ≤1.0%

    ≤1.0%

    0.12%

    0.09%

    Heavy Metal

    <10ppm

    Complies

    As

    <0.1ppm

    0.05ppm

    Pb

    <0.1ppm

    0.05ppm

    Cd

    <0.1ppm

    0.05ppm

    Residual Solvents

    <100ppm

    Complies

    Residual Pesticide

    Negative

    Complies

    Microbiology

     

     

    Total Plate Count

    <1000cfu/g

    Complies

    Yeast & Mold

    <100cfu/g

    Complies

    E.Coli

    Negative

    Complies

    Salmonella

    Negative

    Complies

    Conclusion

    Conforms with In-house standards

     

    Usage

     

    Function of Tofacitinib Citrate

    1. Rheumatoid arthritis (RA)

    Tofacitinib citrate is a new class of anti-rheumatic drugs approved by the US FDA for the first time in ten years. Compared with other traditional anti-rheumatic drugs, it can not only relieve symptoms, but also slow or stop disease damage. Its clinical therapeutic effect is also comparable to biological drugs such as adalimumab. So far, monoclonal antibodies or fusion proteins are the main clinical treatments for RA, which require injections, and tofacitinib has greater advantages as an oral drug.

     

    The results of clinical studies show that tofacitinib still has satisfactory clinical effects for RA patients whose treatment with biological agents is ineffective. Therefore, these studies have further established its therapeutic status in patients with moderate to severe RA.

     

    2. Treatment of active psoriatic arthritis (PsA)

    In May 2017, the US FDA accepted the supplementary new drug application of Xeljanz and Xeljanz XR for the treatment of adult patients with active psoriatic arthritis (PsA).

     

    The new drug supplement application is based on data from the Phase III clinical development project OPAL. The project includes two pivotal Phase III clinical studies (OPAL Broaden, OPAL Beyond) and a long-term extension study (OPAL Balance), which evaluated the use of tofacitinib in adult patients with active PsA who have previously failed PsA drug therapy. Efficacy and safety.

     

    3. Treat ulcerative colitis (UC)

    In May 2017, in the New England Journal of Medicine, the small molecule JAK inhibitor tofacitinib developed by Pfizer in the treatment of ulcerative colitis (UC) in three phase III clinical trials proved that it is in moderate to severe In UC patients, the treatment of tofacitinib is effective, and the efficacy of many patients can last for more than a year.

     

    4. Treatment of ankylosing spondylitis (AS)

    Ankylosing spondylitis (AS) is an immune-mediated chronic systemic inflammatory disease that affects the spine. Phase II clinical studies have confirmed the efficacy and safety of tofacitinib in the treatment of active AS.

     

    Clinical trial showed that nearly 30% of patients with AS who received tofacitinib can achieve a clinically significant reduction in MRI inflammation of the spine; compared with patients in the placebo group, the sacroiliac of the tofacitinib group The joint scores and spine scores both improved and were dose-related; the proportion of patients in the tofacitinib group that achieved MCID of the sacroiliac joint or spine was 4 times that of the placebo group; the clinical response rate of patients in the tofacitinib group who achieved MCID higher.

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