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content-assay

Page 11 of 19 · 438 questions tagged content-assay.

438 questions · sorted by votes · page 11 of 19

17 votes5 answers21k views
What counter-ion should I expect on a CPC tirzepatide lot?

Conditions: CPC · 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 samir_bennani 13k · 18 months ago
17 votes 5 answers19k views
What counter-ion should I expect on a JEEP orforglipron lot?

Numbers first: JEEP · 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 orla_sheridan 14k · 22 months ago
17 votes 5 answers15k views
What counter-ion should I expect on a WWB dulaglutide lot?

Numbers first: WWB · dulaglutide. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone else’s…

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 rota_site 55k · 6 months ago
17 votes 5 answers13k views
Why did two QYB lots of semaglutide differ on content assay?

The particulars: QYB · semaglutide. An unexpected observation, and I would like a differential rather than reassurance. The conditions were within what I understood…

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 RP_C18 85k · 6 months ago
17 votes 5 answers12k views
Does oxidation of oral semaglutide at minus 80 °C show up as a loss of content or of purity?

Concretely: oxidation · oral semaglutide · minus 80 °C. I want to know whether this is a real physical effect or an artefact of how it is measured. What prompted 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
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_Aoife_Brennan 50k · 14 months ago
17 votes5 answers9.9k views
What counter-ion should I expect on a JEEP retatrutide lot?

What I have: JEEP · retatrutide. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone else’s…

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 mira_sundqvist 19k · 15 months ago
17 votes0 answers6.4k views
Why does compounded dulaglutide potency vary between pharmacies?

The pharmacy is accredited and I have verified that on the accreditor register. The empirical answer seems settled. The explanation does not. If the honest answer is…

compounding
compounding

Compounded preparations: what a 503A and a 503B facility may legally prepare and when, base versus salt forms, beyond-use dating under USP…

61 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
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 halvard_ness 42k · 5 months ago
17 votes 3 answers5.4k views
What counter-ion should I expect on a Homopeptide liraglutide lot?

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

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 imani_dube 19k · 7 months ago
17 votes5 answers5.4k views
Does mazdutide adsorb measurably to the vial wall at 2.5 mg/mL?

Details up front: mazdutide · 2.5 mg/mL. This should be a straightforward calculation and I keep getting two different answers. The numbers are arbitrary; the method…

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 jana_horakova 15k · 8 months ago
16 votes5 answers30k views
Why did two SWB lots of orforglipron differ on content assay?

Numbers first: SWB · orforglipron. Before I write this off, I want to check whether it is a known failure mode. I have the lot number, the certificate and the date,…

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 k_szabo 45k · 19 months ago
16 votes 5 answers27k views
What counter-ion should I expect on an SWB orforglipron lot?

Numbers first: SWB · orforglipron. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone else’s…

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 tare_and_weigh 18k · 18 months ago
16 votes 5 answers21k views
Would you accept 96.8% on survodutide from WWB without a content assay?

The specifics, since they change the answer: 96.8% · survodutide · WWB. I am at the decision point and I would rather think it through than improvise. I would rather…

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 Dr_Sara_Kuusela 46k · 18 months ago
16 votes 5 answers20k views
Does oxidation of oral semaglutide at 40 °C show up as a loss of content or of purity?

Concretely: oxidation · oral semaglutide · 40 °C. I want to know whether this is a real physical effect or an artefact of how it is measured. What prompted 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
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 bac_or_bust 37k · 16 months ago
16 votes 5 answers17k views
Would you accept 99.1% on survodutide from JEEP without a content assay?

For reference: 99.1% · survodutide · JEEP. 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 zeynep_arslan 20k · 7 months ago
16 votes4 answers12k views
How much of the gross vial mass is peptide, water and counter-ion?

I have the report as a PDF with the chromatogram on page two, so I can quote specifics. This should be a straightforward calculation and I keep getting two different…

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
water-content
water-content

Residual moisture in a lyophilised solid, measured by Karl Fischer titration or loss on drying. It drives both the mass balance on a content assay…

39 questions
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
asked by sample_id 17k · 7 months ago
16 votes 5 answers11k views
Does aspartimide formation of tirzepatide at 40 °C show up as a loss of content or of purity?

The case in front of me: aspartimide formation · tirzepatide · 40 °C. This is one of those things that everyone repeats and nobody derives. This matters practically,…

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_Signe_Baldursdottir 46k · 5 months ago
16 votes 3 answers8.2k views
Does aggregation of a GLP-1 receptor agonist at 25 °C show up as a loss of content or of purity?

Stated plainly: aggregation · a GLP-1 receptor agonist · 25 °C. The empirical answer seems settled. The explanation does not. If the honest answer is that nobody…

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 swab_stopper 16k · 5 months ago
16 votes 1 answer6.9k views
Why did two QYB lots of ecnoglutide differ on content assay?

For reference: QYB · ecnoglutide. Something has gone wrong and I would like to know how badly before I decide what to do. Nothing else in the setup changed, which is…

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 colm_dunphy 16k · 4 months ago
16 votes 5 answers6.9k views
Does a large published testing history at FGP imply lot consistency?

The lot number on the vial matches the certificate, which at least rules out the easy problem. I keep seeing this stated as a fact with no explanation attached, and…

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 Dr_Jonas_Halvorsen 41k · 4 months ago
16 votes 2 answers6.4k views
Does survodutide adsorb measurably to the vial wall at 8 mg/mL?

The case in front of me: survodutide · 8 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…

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 lucia_marchetti 18k · 3 months ago
16 votes0 answers6k views
Is identity confirmation by mass spectrometry worth paying for on top of a purity figure for survodutide?

For reference: identity confirmation by mass spectrometry · survodutide. I am at the decision point and I would rather think it through than improvise. I would rather…

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
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
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,…

261 questions
asked by j_wierzbicki 45k · 19 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…

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 colm_dunphy 16k · 2 months ago
15 votes 5 answers38k views
Would you accept 98.4% on a GLP-1 receptor agonist from CPC without a content assay?

What I am working with: 98.4% · a GLP-1 receptor agonist · CPC. I would like to set this up properly once, rather than adjust it repeatedly. My budget is real but not…

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 linnea_wahlberg 14k · 2.3 years ago
15 votes 5 answers23k views
Why did two CPC lots of liraglutide differ on content assay?

Conditions: CPC · 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 dead_volume 49k · 2.3 years ago