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content-assay

Page 16 of 19 · 438 questions tagged content-assay.

438 questions · sorted by votes · page 16 of 19

8 votes 5 answers14k views
Does aggregation of mazdutide at 25 °C show up as a loss of content or of purity?

Stated plainly: aggregation · mazdutide · 25 °C. The empirical answer seems settled. The explanation does not. If the honest answer is that nobody knows, I would…

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 ten_mg_vial 16k · 21 months ago
8 votes5 answers13k views
What counter-ion should I expect on a GL Biochem semaglutide lot?

For reference: GL Biochem · semaglutide. I want to understand what this actually establishes, as opposed to what it is being used to imply. My concern is that I am…

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 threadlock7 14k · 15 months ago
8 votes 3 answers12k views
Would you accept 98.2% on orforglipron from SSA without a content assay?

What I have: 98.2% · orforglipron · SSA. This is a planning question. I know what my options are; I do not know how to weigh them. What I want is the minimum viable…

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 ten_mg_vial 16k · 13 months ago
8 votes5 answers11k views
Does semaglutide adsorb measurably to the vial wall at 5 mg/mL?

Conditions: semaglutide · 5 mg/mL. Please show the division. I want to check my own against yours. I would like the general form as well as the specific number, so 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 kwn_analytical 89k · 18 months ago
8 votes5 answers11k views
Is loss on drying interchangeable with Karl Fischer?

I have both a purity figure and a content figure, which is why the discrepancy is visible. I am trying to choose between two options that are usually discussed as…

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
lyophilisation
lyophilisation

Freeze-drying: primary and secondary drying, collapse temperature, the role of bulking agents and cryoprotectants such as mannitol and trehalose,…

17 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 tandem_gradient 85k · 12 months ago
8 votes5 answers9.5k views
What does a Karl Fischer water content test add for tirzepatide that a purity figure does not?

Conditions: a Karl Fischer water content test · tirzepatide. These are treated as interchangeable and I do not think they are. If both are acceptable I would like to…

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 Dr_Ilse_Vandenberg 78k · 8 months ago
8 votes 5 answers7.8k views
Does semaglutide adsorb measurably to the vial wall at 8 mg/mL?

Concretely: semaglutide · 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 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
asked by dermot_kiely 14k · 3 months ago
8 votes0 answers6.9k views
Would you accept 96.4% on semaglutide from KP without a content assay?

The particulars: 96.4% · semaglutide · KP. 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 anders_vestby 17k · 13 months ago
8 votes5 answers5.4k views
A COA says 99.2% purity and 6.1 mg content — is that contradictory?

This is my second independent submission on material from the same supplier. I have the document in front of me and I can read the numbers. What I cannot do is…

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
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 otto_brenner 19k · 5 months ago
8 votes5 answers4.9k views
Why did two TFC lots of liraglutide differ on content assay?

The case in front of me: TFC · liraglutide. I think I have a problem. I am not yet sure whether it is a real problem or a measurement artefact. I want to know whether…

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 ahmed_zerouali 19k · 4 months ago
8 votes 5 answers4k views
Does oxidation of tirzepatide at minus 20 °C show up as a loss of content or of purity?

The case in front of me: oxidation · tirzepatide · minus 20 °C. I want to know whether this is a real physical effect or an artefact of how it is measured. What…

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 vial_five 15k · 4 months ago
8 votes2 answers3.8k views
Would you accept 97.6% on orforglipron from GL Biochem without a content assay?

Numbers first: 97.6% · orforglipron · GL Biochem. This is a planning question. I know what my options are; I do not know how to weigh them. What I want is the minimum…

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 coring_risk 17k · 5 months ago
7 votes 5 answers17k views
Would you accept 96.4% on a GLP-1 receptor agonist from HJ without a content assay?

Stated plainly: 96.4% · a GLP-1 receptor agonist · HJ. I would like to set this up properly once, rather than adjust it repeatedly. My budget is real but not tight,…

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 noor_alhassan 15k · 17 months ago
7 votes 5 answers15k views
Why did two JEEP lots of dulaglutide differ on content assay?

Numbers first: JEEP · dulaglutide. 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 kelvin_lam 11k · 10 months ago
7 votes 5 answers11k views
Would you accept 98.2% on a GLP-1 receptor agonist from QST without a content assay?

What I am working with: 98.2% · a GLP-1 receptor agonist · QST. 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 bridget_nyathi 16k · 16 months ago
7 votes5 answers11k views
What counter-ion should I expect on a QSC a GLP-1 receptor agonist lot?

What I am working with: QSC · a GLP-1 receptor agonist. I would like help reading this properly rather than being told what conclusion to reach. I have the full…

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 ruaidhri_o_shea 51k · 17 months ago
7 votes 5 answers11k views
Does aspartimide formation of liraglutide at room temperature show up as a loss of content or of purity?

Conditions: aspartimide formation · liraglutide · room temperature. 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 otto_brenner 19k · 7 months ago
7 votes0 answers3.9k views
Would you accept 96.8% on mazdutide from Homopeptide without a content assay?

Setup, so nobody has to ask: 96.8% · mazdutide · Homopeptide. I am trying to build something sustainable rather than something thorough that I will abandon. I have…

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 grainne_ahearn 13k · 6 months ago
7 votes 5 answers2.7k views
Why did two SGN lots of orforglipron differ on content assay?

What I have: SGN · 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, 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
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 greta_holzmann 15k · 3 months ago
7 votes 5 answers2.1k views
Is peptide mapping worth paying for on top of a purity figure for semaglutide?

The specifics, since they change the answer: peptide mapping · semaglutide. I would like to define my thresholds before I have a result, for obvious reasons. I want 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
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 ines_delacruz 16k · 5 days ago
7 votes0 answers1.6k views
What does a Karl Fischer water content test add for oral semaglutide that a purity figure does not?

Concretely: a Karl Fischer water content test · oral semaglutide. These are treated as interchangeable and I do not think they are. If both are acceptable I would…

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 cold_lane 14k · 2 months ago
6 votes 5 answers24k views
What does identity confirmation by mass spectrometry add for survodutide that a purity figure does not?

The specifics, since they change the answer: identity confirmation by mass spectrometry · survodutide. I am trying to choose between two options that are usually…

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 Dr_Wren_Halliday 40k · 21 months ago
6 votes 5 answers23k views
What counter-ion should I expect on an SSA survodutide lot?

The specifics, since they change the answer: SSA · survodutide. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I…

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 klara_novotna 16k · 20 months ago
6 votes 5 answers20k views
Does fibrillation of survodutide at 25 °C show up as a loss of content or of purity?

For reference: fibrillation · survodutide · 25 °C. I would like the mechanism, because I want to be able to reason about the cases nobody has written about. I have…

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 zainab_mustafa 16k · 18 months ago