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content-assay

Page 12 of 19 · 438 questions tagged content-assay.

438 questions · sorted by votes · page 12 of 19

15 votes3 answers22k views
Why did two HJ lots of liraglutide differ on content assay?

The case in front of me: HJ · liraglutide. I have two candidate explanations and no way to distinguish them. The same procedure has worked without incident several…

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 felix_araya 17k · 2.0 years ago
15 votes 5 answers20k views
How does reference-standard error propagate into a cagrilintide content figure?

I have both a purity figure and a content figure, which is why the discrepancy is visible. I can do the algebra. I am not confident about the conversion factors. If…

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 micron22 36k · 11 months ago
15 votes 5 answers17k views
What counter-ion should I expect on an FGP mazdutide lot?

Stated plainly: FGP · mazdutide. I have read the primary source rather than the summary, which has left me with more questions. I understand the headline. I do not…

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 cal_hennessy 14k · 19 months ago
15 votes 5 answers15k views
Does oxidation of liraglutide at 37 °C show up as a loss of content or of purity?

Concretely: oxidation · liraglutide · 37 °C. I want to know whether this is a real physical effect or an artefact of how it is measured. What prompted the question is…

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 ahmed_zerouali 19k · 12 months ago
15 votes 5 answers13k views
Why did two WXT lots of cagrilintide differ on content assay?

Stated plainly: WXT · cagrilintide. This is not behaving the way I expected and I want to understand the discrepancy before I act on it. I have photographed the…

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 gradient_slope 41k · 9 months ago
15 votes 5 answers11k views
Does liraglutide adsorb measurably to the vial wall at 10 mg/mL?

The particulars: liraglutide · 10 mg/mL. I would like the arithmetic checked rather than the conclusion asserted. I have deliberately not used an online calculator…

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 teodora_ilic 15k · 15 months ago
15 votes5 answers10k views
Does racemisation of orforglipron at room temperature show up as a loss of content or of purity?

Numbers first: racemisation · orforglipron · room temperature. I can predict the outcome but I cannot explain it, which means I will get the next case wrong. 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 sasha_ferreira 15k · 3 months ago
15 votes 5 answers9.6k views
Why did two QYB lots of survodutide differ on content assay?

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

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 rhian_prydderch 44k · 14 months ago
15 votes 5 answers7k views
What counter-ion should I expect on an HJ oral semaglutide lot?

The case in front of me: HJ · oral semaglutide. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if 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
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 s_bhattacharya 42k · 4 months ago
15 votes0 answers5.3k views
What counter-ion should I expect on a KP dulaglutide lot?

Details up front: KP · dulaglutide. 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 kelvin_lam 11k · 8 months ago
15 votes 5 answers4.4k views
Would you accept 95.2% on semaglutide from SGN without a content assay?

The particulars: 95.2% · semaglutide · SGN. 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 pk_curve 12k · 5 months ago
15 votes0 answers1.9k views
Does survodutide adsorb measurably to the vial wall at 5 mg/mL?

Conditions: survodutide · 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 two_two_micron 15k · 4 months ago
14 votes0 answers21k views
Would you accept 97.9% on retatrutide from GGPeps without a content assay?

Details up front: 97.9% · retatrutide · GGPeps. 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 bridget_nyathi 16k · 2.4 years ago
14 votes5 answers21k views
Why did two CPC lots of oral semaglutide differ on content assay?

The case in front of me: CPC · oral semaglutide. I have two candidate explanations and no way to distinguish them. The same procedure has worked without incident…

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 per_haugen 18k · 15 months ago
14 votes 5 answers16k views
How much of the gross mass of a 15 mg semaglutide vial is actually peptide?

The particulars: 15 mg · semaglutide. I would like the arithmetic checked rather than the conclusion asserted. I have deliberately not used an online calculator…

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 · 2.1 years ago
14 votes5 answers15k views
How much of the gross mass of a 30 mg dulaglutide vial is actually peptide?

Details up front: 30 mg · dulaglutide. I can do the algebra. I am not confident about the conversion factors. If there is a standard way to lay this out, 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
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 rune_thoresen 14k · 12 months ago
14 votes 5 answers14k views
Does deamidation of semaglutide at 30 °C show up as a loss of content or of purity?

The specifics, since they change the answer: deamidation · semaglutide · 30 °C. I understand the observation; what I do not understand is the mechanism behind it. 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 bounty_hunter_q 18k · 8 months ago
14 votes5 answers13k views
Does hydrolysis of dulaglutide at 30 °C show up as a loss of content or of purity?

Details up front: hydrolysis · dulaglutide · 30 °C. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware this may have a boring…

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 ellis_thorne 17k · 23 months ago
14 votes 2 answers12k views
Does a large published testing history at ERP imply lot consistency?

The method section is present, which is unusual enough that I want to make use of it. The empirical answer seems settled. The explanation does not. If the honest…

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 rosa_mendieta 13k · 8 months ago
14 votes 5 answers9k views
Does aspartimide formation of tirzepatide at 25 °C show up as a loss of content or of purity?

Concretely: aspartimide formation · tirzepatide · 25 °C. This is one of those things that everyone repeats and nobody derives. This matters practically, not just…

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 two_two_micron 15k · 11 months ago
14 votes 5 answers7.9k views
What does identity confirmation by mass spectrometry add for semaglutide that a purity figure does not?

The specifics, since they change the answer: identity confirmation by mass spectrometry · semaglutide. 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 sample_id 17k · 6 months ago
14 votes 5 answers6k views
Does orforglipron adsorb measurably to the vial wall at 5 mg/mL?

Stated plainly: orforglipron · 5 mg/mL. I have worked this out and I would like someone to find the error, because I suspect there is one. My working so far, for 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 ten_mg_vial 16k · 10 months ago
14 votes 5 answers4.7k views
Does dimerisation of cagrilintide at minus 80 °C show up as a loss of content or of purity?

Stated plainly: dimerisation · cagrilintide · minus 80 °C. I keep seeing this stated as a fact with no explanation attached, and unexplained facts make me suspicious.…

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 forty_two_c 43k · 14 days ago
14 votes3 answers3.9k views
How much of the gross mass of a 15 mg ecnoglutide vial is actually peptide?

The specifics, since they change the answer: 15 mg · ecnoglutide. I would rather understand the derivation than memorise the outcome. Two people I asked gave two…

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 e_dziedzic 87k · 1 months ago