Home Forums Main Forum Experts Corner Compounding README – THE CORRECT API WEIGHTS TO USE

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  • #18111
    Avatar photoklhilde
    • Guardian Angel
    • ★★★★★
    @klhilde

    As there are a few patients out there who have relapsed and who may be looking to other meds for their next round of treatment, do we have the correct API weights for some of the other drugs available from Mesochem?

    I’m specifically wondering about Velpatasvir and Simeprevir, but Mesochem currently has eight Hep C meds available, including one more NS5A, one more NS5B and one more NS3/4A.

    #18129
    dope-on-a-rope.jpgDr James
    • Guardian Angel
    • ★★★★★
    @fixhepc

    I’m specifically wondering about Velpatasvir and Simeprevir, but Mesochem currently has eight Hep C meds available, including one more NS5A, one more NS5B and one more NS3/4A.

    The spreadsheet above includes velpatasvir (100mg API) and simeprevir sodium (154.6mg API) without correcting for purity.

    Note that simeprevir is insoluble, and simeprevir sodium is what’s required. Also note that if you look at this redacted report from Japan https://www.pmda.go.jp/files/000153596.pdf even the originator could not make it sufficiently pure to reach ICH Q3A and ICH Q3B standards http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3A_R2/Step4/Q3A_R2__Guideline.pdf and and that “related substance C” was the problem and that “related substance C” is cardiotoxic.

    While we are here please note that CAS numbers are specific and the ones quoted in the spreadsheet are the correct ones. Like Simeprevir, Daclatasvir (CAS 1009119-64-5) is also insoluble which is why Daclatasvir 2HCl (2 hydrochloride salt) (CAS 1009119-65-6) is used.


    YMMV

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