Residual Solvents in Certificate of Analysis

This topic has 25 replies, 11 voices, and was last updated 8 years, 11 months ago by LondonGirl.

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24 December 2015 at 5:46 am #7180
berrinice
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- Guardian Angel
@berrinice
I wonder if anyone can tell me how much is a safe level of ethanol in Daclatasvir? I was wondering if 38% is too much? kindly
24 December 2015 at 5:48 am #7181
berrinice
- Topics: 10
- Replies: 122
- Total: 132
- Guardian Angel
@berrinice
whoops should red 0.38% ETHANOL .
24 December 2015 at 5:53 am #7182
splitdog
- Topics: 5
- Replies: 374
- Total: 379
- Guardian Angel
@splitdog
What is the source?

splitdog@roadrunner.com

Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.
SVR 44 <15 Not Detected.

Thank you Jesus.
Thank you Dr. James
24 December 2015 at 6:02 am #7184
berrinice
- Topics: 10
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- Total: 132
- Guardian Angel
@berrinice
kingswood pharmacy in sydney
24 December 2015 at 6:04 am #7187
berrinice
- Topics: 10
- Replies: 122
- Total: 132
- Guardian Angel
@berrinice
I have just been diagnosed deficient B12 & folic acid associated with a) alcoholism or b) leukemia
24 December 2015 at 6:05 am #7188
splitdog
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- Total: 379
- Guardian Angel
@splitdog
I have no idea. It is probably used in making the product. Being an alcohol, it probably just wasn’t dried out quite all the way.
I just ordered that from them today.

splitdog@roadrunner.com

Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.
SVR 44 <15 Not Detected.

Thank you Jesus.
Thank you Dr. James
24 December 2015 at 6:06 am #7189
berrinice
- Topics: 10
- Replies: 122
- Total: 132
- Guardian Angel
@berrinice
be very careful. I am going to get my money back
24 December 2015 at 6:10 am #7191
berrinice
- Topics: 10
- Replies: 122
- Total: 132
- Guardian Angel
@berrinice
the dickie batch no is 20150929
24 December 2015 at 6:11 am #7192
splitdog
- Topics: 5
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- Total: 379
- Guardian Angel
@splitdog
berrinice wrote:

be very careful. I am going to get my money back

Why?

splitdog@roadrunner.com

Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.
SVR 44 <15 Not Detected.

Thank you Jesus.
Thank you Dr. James
24 December 2015 at 6:14 am #7193
splitdog
- Topics: 5
- Replies: 374
- Total: 379
- Guardian Angel
@splitdog
Why not call the pharmacy and ask them. They’re open a few more hours.

splitdog@roadrunner.com

Genotype 3
VL 4,100,000
ALT 101 AST 71
Treatment Naive
Started Sof/Dac Jan 12, 2016
VL= <15 4 weeks in. AST/ALT normal.
VL=UNDETECTED 8 weeks in.
SVR4= Virus back. 3,300,000

Started generic Epclusa Sep. 23, 2017

4 weeks in <15 *Detected.
12 weeks in <15 *Not Detected.
16 weeks in <15 *Not Detected.
Finished 24 weeks treatment 3-17-18
SVR5 <15 Not Detected.
SVR 20 <15 Not Detected.
SVR 44 <15 Not Detected.

Thank you Jesus.
Thank you Dr. James
24 December 2015 at 7:02 am #7197
sonix
- Topics: 7
- Replies: 158
- Total: 165
- Guardian Angel
@sonix
The Certificate of analysis I got from Kingswood for Dac says it should be less than 0.5%, so 0.38% is fine. My Dac came from the same batch.

M 61yo HCV+ ~ 30 yrs Gt1a F2 VL 223,000 ALT 54 AST 42 Tx start Sof/Dac 17Dec15.
SVR4 at 7Apr16 ALT 22 AST 22
SVR12 at 9Jun16 ALT 23 AST 25
Melbourne, Australia
24 December 2015 at 7:59 am #7201
Gaj
- Topics: 29
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- Guardian Angel
@gaj
berrinice wrote:

I have just been diagnosed deficient B12 & folic acid associated with a) alcoholism or b) leukemia

Hi berrinice,

0.38% of 60mg daily is equivalent of 1/44,000 of a standard drink so the traces of ethanol in the Dac won’t be the cause of the deficiencies. While it is associated with alcoholism the alcohol isn’t the cause. Most likely it is a dietary deficiency, are you vegan or on a low animal product diet? Regardless, your GP needs to investigate it to determine the cause. Here is some info in relation to hep c.

http://hepatitiscnewdrugs.blogspot.com.au/2011/01/liver-disease-and-vitamin-b-12.html

G

G3a since ’78 – Dx ’12 – F4 (2xHCC)
24wk Tx – PEG/Riba/Dac 2013 relapsed
24wk Tx – Generic Sof/Dac/Riba 2015/16 relapsed
16wk Tx – 12/01/17 -> 03/05/17 NS3/NS5a + Generic Sof
SVR7 – 22/06/17 UND
SRV12 – 27/07/17 UND
SVR24 – 26/10/17 UND
24 December 2015 at 9:13 am #7209
Dr James
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- Guardian Angel
@fixhepc
It is entirely usual that there are residual solvents present. They are the main reason that the purity is 99.x%

In the Daclatasvir we use the residual solvent is Ethyl Acetate CH3COOH (this is in nail polish remover and model airplane glue).

Ethanol is CH3CH2OH, and is a similar solvent.

If you think back to high school chemistry you probably remember dissolving crystal in liquid (solvent) and then mixing two things to make something else. This is the same as on industrial scale – the crystals of pure material are made in a solvent and it is increasingly expensive to remove all of it so we settle for 99.x% purity.

YMMV
24 December 2015 at 12:29 pm #7222
crazy8
- Topics: 0
- Replies: 49
- Total: 49
- Recovery Champion
@crazy8
Hi Berrinice, My latest blood tests showed a b12 and folate deficiency aswell, it only turned up after starting ribavirin along with a couple of other unpleasant side effects, I’ve stopped the ribavirin, 24 weeks of Sof/Dac seems to work better without it in gen 3’s anyway, but the ribavirin side effects continue to linger. And will take some time to leave my system. Ribavirin causes anemia which is also a factor in b12 and folate deficiency (according to what I’ve read) Are you taking ribavirin?

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*
24 December 2015 at 1:11 pm #7224
berrinice
- Topics: 10
- Replies: 122
- Total: 132
- Guardian Angel
@berrinice
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.
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