98.5% up by HPLC Sitagliptin 486460-32-6

Category:Active Pharmaceutical Ingredients > Other Active Pharmaceutical Ingredients
Product Name:98.5% up by HPLC Sitagliptin 486460-32-6
CAS No.:486460-32-6
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

    Sitagliptin

    Molecular Formula

    C16H15F6N5O

    Molecular Weight

    407.32

    CAS No.

    486460-32-6

    Quality Standard

    98.9% up, medical grade

    Appearance

    White powder

     

    COA of Sitagliptin

     

    ITEMS

    STANDARDS

    RESULTS

    Appearance

    White or off-white crystalline powder

    Complies

    Identification

    A.    Sitagliptin phosphate in water display discriminate reaction of phosphate.

    B.    HPLC: RRT test solution is similar to RRT reference solution.

    C.    IR: Similar to Reference Substance

    Complies

     

     

    Complies

     

    Complies

     

    Related substance

    XG-E ≤0.15%

    N.D.

    XG-F ≤0.15%

    N.D.

    XG-G ≤0.15%

    N.D.

    XG-H ≤0.15%

    N.D.

    XG-K ≤0.15%

    N.D.

    XG-L ≤0.15%

    0.01%

    XG-M ≤0.15%

    N.D.

    XG-N ≤0.15%

    N.D.

    Other individual impurity ≤0.10%

    N.D.

    Total impurities ≤0.5%

    0.01%

    Isomer

    XG-A ≤0.15%

    N.D.

    Water

    3.0%~4.5%

    3.6%

    Residual solvents

    Isopropyl alcohol ≤0.5%

    0.02%

    Methyl tert-bytyl ether ≤0.5%

    N.D.

    Acetoacetate ≤0.5%

    N.D.

    Dimethylformamide ≤0.088%

    N.D.

    Heavy metals

    ≤ 10ppm

    Complies

    Assay

    ≥98.5% on anhydrous basis

    100.3%

    Conclusion

    Conforms to enterprise standard

     

    Usage

     

    Function of Sitagliptin

     

    Sitagliptin is for dipeptide peptidase 4 (DPP - 4) depressants, by protecting endogenous im fall blood sugar, and enhance its role and control blood sugar levels. Glucose dependence on promoting insulin releasing peptide (GIP) and glucagon peptide 1 (glp-1), as for dietary intake and release of intestinal fall blood sugar.


    4 randomized, placebo-controlled trials involving more than 2,000 type 2 diabetes patients evaluated the effect and safety of sitagliptin alone or in combination with other hypoglycemic drugs Sex. The evaluation index is mainly the change value of glycosylated hemoglobin (HbA1c) from the baseline. HbA1c is an indicator of the average blood glucose level in the past 3-4 months. Sitagliptin (100 or 200 mg) alone significantly reduced HbA1c levels. The reduction in HbA1c levels was proportional to the initial level of HbA1c. There was no increase in patient weight during the 24 weeks of single treatment. Sitagliptin reduces fasting and postprandial blood sugar, increases the ratio of preproinsulin/insulin, and improves insulin resistance.

     

    For patients with at least 1500 mg of metformin a day that still cannot control blood sugar well, sitagliptin 100 mg was added. 47% of patients reached the target of HbA1C <7%, while only 18.3% of patients who received placebo achieved the target. Compared with the placebo group, HbA1C in the sitagliptin group decreased by 0.65% on average. The combination of Sitagliptin and metformin has also been shown to be effective as an initial treatment. Patients who were treated with pioglitazone and could not reach the goal (mean HbA1C level was 8.1%) were added sitagliptin 100mg, and the average HbA1C level of patients was reduced by 0.7%. Compared with the pioglitazone alone treatment group, a higher proportion of patients reached HbA1C<7% aims.

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