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TOPIC: Residual Solvents in Certificate of Analysis

Residual Solvents in Certificate of Analysis 5 years 4 months ago #6145

  • klhilde
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Ummm .... I got my meds from Kingswood and got the same copy of the certificate of analysis.

Call me crazy, but .... I'm willing to state with extremely high confidence that the quality of Kingswood's photocopier/printer will have no impact on the effectiveness of Mesochem's APIs.
:lol:


Edit: To put GAJ's number into a time perspective, to get the same quantity of alcohol as in one shot glass by taking one pill of Daclatasvir daily would require a treatment duration of 120 years plus 200 days.

Edit II: Oops, I made a mistake ... Using the Gregorian calendar it would only be 120 years and 170.9 days.
Last Edit: 5 years 4 months ago by klhilde.
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Residual Solvents in Certificate of Analysis 5 years 4 months ago #6148

  • berrinice
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I find this new illness serious otherwise I would have asked a comedian their opinion
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Residual Solvents in Certificate of Analysis 5 years 4 months ago #6149

  • crazy8
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berrinice wrote:
no riba for about 3 weeks. its not diet, meat eater. I had bristol myer squibb daclatasvir for 3 months, then bought in sydney after a couple of weeks I starting getting really tired again like with hep so I had thyroid and a blood test which showed b12 and folic acid deficiency, the only thing that changed was the source of declatasvir. Also I am not happy with the shoddy certificate of analysis that came with the meds.

Ribavirin will stay in your system longer than 3 weeks I'm sure I was told, I think you'll find people taking that crap will show the same deficiency pattern, was your hemaglobin and red blood cells down aswell?
GT 3, F3, Contracted 1993 Tx Naive
V/L 1,267,000 AST 67 ALT 65 6/10/15
commence Sof/Dac (Mesochem) 6/11/15
AST ALT normal 24/11 *
*V/L UNDETECTED 24/11*
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Residual Solvents in Certificate of Analysis 5 years 4 months ago #6154

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Did you get a certificate of analysis with the Daklinza?

I'm pretty sure that its only purpose with the generics is to prove they tested it and to show the customs official if its importation is questioned.
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Residual Solvents in Certificate of Analysis 5 years 4 months ago #6157

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it was from sourced from here . that chemist uses a firm called astral scientific - not sure if they put the compounds together, nobody mentioned meschocem
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Residual Solvents in Certificate of Analysis 5 years 4 months ago #6171

  • Wayne
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Hi Bernice typed residual solvent analysis in Pharmaceuticals into search engine the residue you are referring too is a class 3 solvent least harmful group allowable amount is.5 .38 the meds you have is safe.
You would most likely find every medication out there will have one of these solvents in them.
But I'm not a Doctor or Scientist. :)
Genotype 1b 42 years.
2007 48 Weeks Interferon + Ribavirin Relapsed.
2015 6 Weeks same as above + Sempivir Too many sides stopped.
7/11/15 started Sof / Dac + Riba 24 Weeks. Kingswood Pharmacy.
VL Before tx 3 million.
1st bloods 8 weeks undetected
.
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Residual Solvents in Certificate of Analysis 5 years 4 months ago #6174

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Wayne and others are right, here's a link to everything you would ever want to know (and more) about residual solvents in medicines.

The solvent in the daclatasvir is in the class 3 category, the ones that have been determined to have no harmful effects.

The allowable threshold is for this class is .5, and yours are .38. According to the rules posted in these guidelines, that's a safe, allowable amount and the manufacturer need do no more if he hits that under .5 mark.

Solvents have to be used in the manufacture process, and I doubt any manufacturer gets all traces removed to the point of 0.0. I've been taking the Kingswood daclatasvir for about 7 weeks now, with no issues, I really think you might want to be looking elsewhere for the issue you're having, than the trace amount of Class 3 solvent. Here's the link to the article I found, that was very thorough, on the subject:

www.usp.org/sites/default/files/usp_pdf/...hapter467Current.pdf
GT 2b; since 80's, no prior tx, sofosbuvir and daclatasvir compounded from API's at Kingswood Pharmacy in Sydney, started tx nov 6,2015, undetected at 4 wks, UND at 8 weeks, UND at 1 week after EOT, UND at 4 weeks after EOT and UND at 8 weeks after EOT. " I feel GOOD!! I knew that I WOULD!"
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Residual Solvents in Certificate of Analysis 5 years 4 months ago #6267

  • DrJames
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I doubt any manufacturer gets all traces removed to the point of 0.0

Absolutely correct. It is possible to get to purity values of 99, 99.9, 99.99, 99.999 but each extra "9" you want increases the price by a factor of about 9!

HPLC can deliver near 100% purity but does not work at scale, so other more time/cost efficient methods of purification are used.

With residual solvents near enough is good enough. They are normal, expected, and will have no impact on efficacy.
YMMV
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Residual Solvents in Certificate of Analysis 5 years 4 months ago #6613

  • Price
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So are you taking supplements? If not, ask your doctor.

P
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Residual Solvents in Certificate of Analysis 5 years 4 months ago #6614

  • Price
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You need Vitamin B's and folic acid to make red cells. So if they're low then it would be harder to make red cells. Have you asked your doctor about taking supplements?

P.
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Residual Solvents in Certificate of Analysis 5 years 4 months ago #6616

  • LondonGirl
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I have read, if red blood cells very low, suppliments don't work & you need an injection.
Also read eating more VitB foods ie greens doesn't work either (although can't be bad for us).
I definitely feel better for an organic green juice, instant effect!

Any professional opinions in best way to keep up VitB12 / Folic acid levels?
Mine are low pre tx, It does seem to coincide with more joint & muscle pain and steange pains in lower back / coccyx area which don't feel skeletal or muscular and are worse at night.

(edit) Looking at my bloods, from what I have read, all point to malabsorption of the above, instinct tells me this is true for me personally

Oh - Just seen B12 update on postage below!
GT1a Dec14 F2/8.7 VL 900000-2.5M
Jan16 Hepcivir-L MonkMed/Redemption
Baseline: VL 913575 Alt 76 Platelets low
Wk2 VL1157 Alt 23
DET Wk 8 VL 32 Alt19 'In the slow lane'
June16 Fibro 5.7 F0/1 LIF 1.5
Wk 11 VL<12 Alt 13 Det/Unq
Extending tx 12 wks Mylan Sofo/Dac MonkMed
Wk 14 VL <12 Det/Unq
Wk 16 VL UNDETECTED
Wk 22 + 4 Wks Sunprevir FixHepC
Wk 24 UNDETECTED Alt 13
Wk 12 post tx SVR12 Wk 26 SVR24
Thank-you Tim, Dr Debasis @ MonkMed & Dr Freeman @ Fix HepC
Last Edit: 5 years 4 months ago by LondonGirl.
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