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TOPIC: README - THE CORRECT API WEIGHTS TO USE

README - THE CORRECT API WEIGHTS TO USE 2 years 6 months ago #13888

  • DrJames
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Having just read another post from someone about to take the wrong dose.....

The required API weights (per dose) are:

  • Sofosbuvir - 400 mg (to provision 400 mg sofosbuvir free base)
  • Ledipasvir acetone - 96 mg (to provision 90 mg ledipasvir free base)
  • Daclatasvir 2HCl - 66 mg (to provision 60 mg daclatasvir free base)
The required API weights (per 12 weeks) are:

  • 34g Sofosbuvir
  • 8.1g Ledipasvir acetone and
  • 5.6 g Daclatasvir 2HCl

Please follow the instructions above. If you don't understand the instructions above follow them anyway. If that's not clear read it again.

The attached spreadsheet contains the correct CAS numbers for these medications.

If you are sourcing APIs directly
  • get exactly the CAS numbers specified
  • get the total weight specified (x2 for 24 weeks treatment)
  • dose exactly as specified

No Ledipasvir is NOT the same as Ledipasvir acetone, that's why it has a different CAS number.
No Daclatasvir is NOT the same as Daclatasvir 2 hydrochloride (2HCl), that's why it has a different CAS number.
Not Simeprevir is NOT the same as Simeprevir Sodium, that's why it has a different CAS number.

If asked you want Sofosbuvir polymorph Form I if you want the original trial form that is more bioavailable, or Form II (also called 6) if you want what Gilead swapped it out for during commercialisation. It's not a huge deal but go for Form I, it's better.
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YMMV
Last Edit: 2 years 6 months ago by DrJames.
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README - THE CORRECT API WEIGHTS TO USE 2 years 4 months ago #16909

  • klhilde
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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.
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README - THE CORRECT API WEIGHTS TO USE 2 years 4 months ago #16924

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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 www.pmda.go.jp/files/000153596.pdf even the originator could not make it sufficiently pure to reach ICH Q3A and ICH Q3B standards www.ich.org/fileadmin/Public_Web_Site/IC...3A_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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