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content-assay

Page 15 of 19 · 438 questions tagged content-assay.

438 questions · sorted by votes · page 15 of 19

10 votes5 answers22k views
Does semaglutide adsorb measurably to the vial wall at 2 mg/mL?

Conditions: semaglutide · 2 mg/mL. I want the working, not the result — I need to be able to redo it with different numbers. I care about the precision as well as the…

peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

832 questions
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…

438 questions
storage
storage

Storage conditions and their evidence base: minus twenty degrees for powder, refrigerated for solution, protection from light, and what the…

646 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 bounty_hunter_q 18k · 18 months ago
10 votes5 answers20k views
How does reference-standard error propagate into an ecnoglutide content figure?

The method section is present, which is unusual enough that I want to make use of it. Please show the division. I want to check my own against yours. I would like the…

reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

179 questions
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…

438 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…

788 questions
asked by coldpack_88 37k · 17 months ago
10 votes 5 answers20k views
How does reference-standard error propagate into a tirzepatide content figure?

This is my second independent submission on material from the same supplier. I would rather understand the derivation than memorise the outcome. Two people I asked…

reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

179 questions
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…

438 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…

788 questions
asked by pip_okonjo 11k · 13 months ago
10 votes 5 answers17k views
Would you accept 96.4% on liraglutide from WXT without a content assay?

The case in front of me: 96.4% · liraglutide · WXT. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in view and I…

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…

788 questions
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…

438 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by eighty_six_hours 16k · 16 months ago
10 votes 5 answers16k views
Does dimerisation of cagrilintide at 40 °C show up as a loss of content or of purity?

Setup, so nobody has to ask: dimerisation · cagrilintide · 40 °C. I keep seeing this stated as a fact with no explanation attached, and unexplained facts make me…

peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

832 questions
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…

438 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…

788 questions
asked by Dr_Lena_Ostrowska 42k · 18 months ago
10 votes 5 answers12k views
Would you accept 98.4% on ecnoglutide from SGN without a content assay?

The particulars: 98.4% · ecnoglutide · SGN. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with explicit stopping…

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…

788 questions
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…

438 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by ekaterina_volk 16k · 12 months ago
10 votes 3 answers7.4k views
What counter-ion should I expect on an ERP cagrilintide lot?

Setup, so nobody has to ask: ERP · cagrilintide. I have read the primary source rather than the summary, which has left me with more questions. I understand the…

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…

87 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…

788 questions
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…

438 questions
asked by elke_brunner 14k · 4 months ago
10 votes 1 answer6.9k views
What counter-ion should I expect on a WWB orforglipron lot?

Details up front: WWB · orforglipron. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear to disagree,…

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…

87 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…

788 questions
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…

438 questions
asked by nkem_obiora 46k · 12 months ago
10 votes0 answers1.3k views
Does aggregation of mazdutide at 2–8 °C show up as a loss of content or of purity?

What I am working with: aggregation · mazdutide · 2–8 °C. The empirical answer seems settled. The explanation does not. If the honest answer is that nobody knows, I…

peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

832 questions
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…

438 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…

788 questions
asked by Dr_Ilse_Vandenberg 78k · 34 days ago
9 votes 5 answers34k views
How does reference-standard error propagate into an oral semaglutide content figure?

I have the report as a PDF with the chromatogram on page two, so I can quote specifics. I would like the arithmetic checked rather than the conclusion asserted. I…

reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

179 questions
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…

438 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…

788 questions
asked by jana_horakova 15k · 2.3 years ago
9 votes5 answers30k views
Would you accept 97.6% on survodutide from SWB without a content assay?

The particulars: 97.6% · survodutide · SWB. I am at the decision point and I would rather think it through than improvise. I would rather spend money on measurement…

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…

788 questions
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…

438 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by assay_blank 39k · 2.0 years ago
9 votes 5 answers29k views
What does a sterility test add for orforglipron that a purity figure does not?

Details up front: a sterility test · orforglipron. I want to know what the trade-off actually is rather than which option is fashionable. I would rather have a…

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…

438 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…

788 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…

749 questions
asked by valentina_rossi 16k · 2.2 years ago
9 votes 5 answers26k views
Does a large published testing history at SSA imply lot consistency?

This is my second independent submission on material from the same supplier. I understand the observation; what I do not understand is the mechanism behind it. I have…

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…

865 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
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…

438 questions
asked by teodora_ilic 15k · 20 months ago
9 votes 4 answers22k views
Would you accept 97.9% on ecnoglutide from WWB without a content assay?

The particulars: 97.9% · ecnoglutide · WWB. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with explicit stopping…

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…

788 questions
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…

438 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by carys_meredith 17k · 23 months ago
9 votes 5 answers21k views
Does a GLP-1 receptor agonist adsorb measurably to the vial wall at 10 mg/mL?

What I have: a GLP-1 receptor agonist · 10 mg/mL. I can do the algebra. I am not confident about the conversion factors. If there is a standard way to lay this out, I…

peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

832 questions
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…

438 questions
storage
storage

Storage conditions and their evidence base: minus twenty degrees for powder, refrigerated for solution, protection from light, and what the…

646 questions
asked by harriet_lonsdale 14k · 2.1 years ago
9 votes5 answers15k views
Would you accept 95.2% on tirzepatide from ERP without a content assay?

Conditions: 95.2% · tirzepatide · ERP. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will follow the plan I write down,…

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…

788 questions
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…

438 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by haze_check 17k · 14 months ago
9 votes4 answers10k views
Does deamidation of semaglutide at minus 20 °C show up as a loss of content or of purity?

The particulars: deamidation · semaglutide · minus 20 °C. I understand the observation; what I do not understand is the mechanism behind it. I have read the two…

peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

832 questions
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…

438 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…

788 questions
asked by Dr_Jonas_Halvorsen 41k · 9 months ago
9 votes 5 answers6.9k views
Does a TFA counter-ion show up in a purity number or a content number?

The method section is present, which is unusual enough that I want to make use of it. I have read the primary source rather than the summary, which has left me with…

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…

87 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…

788 questions
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…

438 questions
asked by a_lindgren 46k · 8 months ago
9 votes5 answers6.4k views
Would you accept 98.2% on orforglipron from MKM without a content assay?

Details up front: 98.2% · orforglipron · MKM. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone can tell me which…

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…

788 questions
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…

438 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by lucia_marchetti 18k · 5 months ago
9 votes2 answers5.6k views
Why did two Homopeptide lots of liraglutide differ on content assay?

Concretely: Homopeptide · liraglutide. I have two candidate explanations and no way to distinguish them. The same procedure has worked without incident several times…

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…

865 questions
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…

438 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by eighty_six_hours 16k · 13 months ago
9 votes5 answers3.8k views
Would you accept 96.4% on cagrilintide from Homopeptide without a content assay?

Setup, so nobody has to ask: 96.4% · cagrilintide · Homopeptide. I would like to set this up properly once, rather than adjust it repeatedly. My budget is real but…

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…

788 questions
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…

438 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by unit_math 13k · 2 months ago
8 votes 3 answers18k views
What counter-ion should I expect on a TFC tirzepatide lot?

Conditions: TFC · tirzepatide. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if the specifics change the…

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…

87 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…

788 questions
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…

438 questions
asked by Dr_Malik_Osei 37k · 2.1 years ago
8 votes 5 answers16k views
Why did two ERP lots of a GLP-1 receptor agonist differ on content assay?

Stated plainly: ERP · a GLP-1 receptor agonist. This is not behaving the way I expected and I want to understand the discrepancy before I act on it. I have…

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…

865 questions
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…

438 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by mass_shift_18 14k · 2.1 years ago
8 votes 5 answers15k views
How does reference-standard error propagate into a survodutide content figure?

The lot number on the vial matches the certificate, which at least rules out the easy problem. I want the working, not the result — I need to be able to redo it with…

reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

179 questions
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…

438 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…

788 questions
asked by day_seven_trough 11k · 10 months ago