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residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and why they are usually absent from a research-grade certificate.

14 questions · sorted by votes

39 votes5 answers37k views
How many vials from a GL Biochem lot should I send for a residual-solvent screen?

Setup, so nobody has to ask: GL Biochem · a residual-solvent screen. I would rather understand the derivation than memorise the outcome. Two people I asked gave two…

batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

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coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

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cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

260 questions
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
asked by meniscus_film 32k · 18 months ago
30 votes2 answers50k views
How many vials from a GGPeps lot should I send for a residual-solvent screen?

What I have: GGPeps · a residual-solvent screen. I would rather understand the derivation than memorise the outcome. Two people I asked gave two answers that differ…

batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

910 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

771 questions
cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

260 questions
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
asked by oona_kekkonen 13k · 2.3 years ago
30 votes 5 answers29k views
What does a residual-solvent screen add for cagrilintide that a purity figure does not?

Setup, so nobody has to ask: a residual-solvent screen · cagrilintide. I suspect the honest answer is that it depends, in which case I would like to know on what.…

content-assay
content-assay

Quantified content: how many milligrams of peptide are actually in the vial, measured against a calibrated reference standard. A separate test…

476 questions
purity
purity

Purity as chromatographic area per cent - the fraction of detected material that is your target peak. It says nothing about how much material is…

833 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

771 questions
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
amylin
amylin

Amylin and its analogues, most prominently cagrilintide, as a satiety mechanism orthogonal to incretin signalling. Includes the pharmacology of…

237 questions
asked by threadlock7 19k · 9 months ago
28 votes 5 answers33k views
How many vials from an SSA lot should I send for a residual-solvent screen?

Setup, so nobody has to ask: SSA · a residual-solvent screen. I would rather understand the derivation than memorise the outcome. Two people I asked gave two answers…

batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

910 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

771 questions
cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

260 questions
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
asked by j_wierzbicki 69k · 12 months ago
27 votes 5 answers25k views
Why is acetate the counter-ion on some lots and TFA on others?

I am comparing a supplier certificate against an independent result on the same lot. The empirical answer seems settled. The explanation does not. If the honest…

acetate-content
acetate-content

Counter-ion content, most often acetate or trifluoroacetate, and why it matters: the counter-ion and residual water are part of the gross mass you…

88 questions
purity
purity

Purity as chromatographic area per cent - the fraction of detected material that is your target peak. It says nothing about how much material is…

833 questions
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
asked by Dr_Ilse_Vandenberg 113k · 2.0 years ago
21 votes5 answers17k views
Why is a residual-solvent figure almost never on a research certificate?

I have the report as a PDF with the chromatogram on page two, so I can quote specifics. I would like the mechanism, because I want to be able to reason about the…

residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

771 questions
purity
purity

Purity as chromatographic area per cent - the fraction of detected material that is your target peak. It says nothing about how much material is…

833 questions
asked by fill_volume 22k · 2.2 years ago
21 votes 5 answers6.5k views
Is a residual-solvent screen worth paying for on top of a purity figure for mazdutide?

For reference: a residual-solvent screen · mazdutide. I am trying to build something sustainable rather than something thorough that I will abandon. I have already…

content-assay
content-assay

Quantified content: how many milligrams of peptide are actually in the vial, measured against a calibrated reference standard. A separate test…

476 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

910 questions
cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

260 questions
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
mazdutide
mazdutide

A GLP-1 and glucagon receptor dual agonist developed primarily in China, with a distinct dose range and a fast-moving publication record.…

237 questions
asked by cap_the_luer 14k · 2 months ago
20 votes 5 answers4.6k views
Is a residual-solvent screen on one vial from a ten-person group buy enough for the whole split?

The particulars: a residual-solvent screen · a ten-person group buy. I would like to set this up properly once, rather than adjust it repeatedly. My budget is real…

group-buy
group-buy

Pooled purchasing: how the economics work, what trust structure a pool needs, splitting a single tested lot, and the failure modes when the…

41 questions
batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

910 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

771 questions
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
asked by gel_pack_warm 13k · 5 months ago
19 votes 2 answers32k views
How many vials from an MKM lot should I send for a residual-solvent screen?

Stated plainly: MKM · a residual-solvent screen. I would rather understand the derivation than memorise the outcome. Two people I asked gave two answers that differ…

batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

910 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

771 questions
cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

260 questions
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
asked by eoin_mcgarry 18k · 2.0 years ago
19 votes 5 answers22k views
Would a residual-solvent screen distinguish hydrolysis from a synthesis impurity in ecnoglutide?

The case in front of me: a residual-solvent screen · hydrolysis · ecnoglutide. Both of these get recommended confidently by different people, which suggests neither…

peptide-mapping
peptide-mapping

Enzymatic digestion followed by LC-MS/MS to confirm sequence rather than just mass. The method that catches a scrambled sequence or a D-amino-acid…

103 questions
purity
purity

Purity as chromatographic area per cent - the fraction of detected material that is your target peak. It says nothing about how much material is…

833 questions
mass-spec
mass-spec

Mass spectrometry for identity confirmation: electrospray ionisation, multiple charge states, monoisotopic versus average mass, deconvolution, and…

52 questions
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
ecnoglutide
ecnoglutide

A long-acting GLP-1 receptor agonist with a cAMP-biased signalling profile. A niche tag, mostly used for mechanism questions about biased agonism…

223 questions
asked by colm_dunphy 8.2k · 18 months ago
16 votes0 answers2.8k views
What does a residual-solvent screen add for a GLP-1 receptor agonist that a purity figure does not?

Setup, so nobody has to ask: a residual-solvent screen · a GLP-1 receptor agonist. I suspect the honest answer is that it depends, in which case I would like to know…

content-assay
content-assay

Quantified content: how many milligrams of peptide are actually in the vial, measured against a calibrated reference standard. A separate test…

476 questions
purity
purity

Purity as chromatographic area per cent - the fraction of detected material that is your target peak. It says nothing about how much material is…

833 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

771 questions
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
asked by colm_dunphy 8.2k · 2 months ago
13 votes 1 answer9.6k views
How many vials from a QYB lot should I send for a residual-solvent screen?

What I am working with: QYB · a residual-solvent screen. I would rather understand the derivation than memorise the outcome. Two people I asked gave two answers that…

batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

910 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

771 questions
cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

260 questions
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
asked by nominal_ten 12k · 11 months ago
11 votes5 answers13k views
What does a residual-solvent screen add for mazdutide that a purity figure does not?

Concretely: a residual-solvent screen · mazdutide. I suspect the honest answer is that it depends, in which case I would like to know on what. Assume I can obtain…

content-assay
content-assay

Quantified content: how many milligrams of peptide are actually in the vial, measured against a calibrated reference standard. A separate test…

476 questions
purity
purity

Purity as chromatographic area per cent - the fraction of detected material that is your target peak. It says nothing about how much material is…

833 questions
coa
coa

Certificates of analysis: what fields a useful one carries, how to tell a real analytical report from a marketing document, batch and lot…

771 questions
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
mazdutide
mazdutide

A GLP-1 and glucagon receptor dual agonist developed primarily in China, with a distinct dose range and a fast-moving publication record.…

237 questions
asked by tri_gly_ala 24k · 23 months ago
2 votes 5 answers7.9k views
How should I budget for a residual-solvent screen across a twelve-month mazdutide course?

Setup, so nobody has to ask: a residual-solvent screen · mazdutide. I am trying to build something sustainable rather than something thorough that I will abandon. I…

batch-testing
batch-testing

Testing at the batch or lot level: sampling plans, how many vials from a lot need testing to say anything about the lot, and the difference…

910 questions
cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

260 questions
janoshik
janoshik

Janoshik Analytical, an independent third-party testing laboratory widely used by this community for HPLC purity, identity and quantified content…

139 questions
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
mazdutide
mazdutide

A GLP-1 and glucagon receptor dual agonist developed primarily in China, with a distinct dose range and a fast-moving publication record.…

237 questions
asked by dana_wexler 11k · 12 months ago
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