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content-assay

Page 8 of 19 · 438 questions tagged content-assay.

438 questions · sorted by votes · page 8 of 19

22 votes 5 answers5.2k views
What counter-ion should I expect on a JEEP dulaglutide lot?

Details up front: JEEP · 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 grainne_ahearn 13k · 2 months ago
22 votes1 answer4k views
Why did two WWB lots of orforglipron differ on content assay?

What I have: WWB · 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 rune_thoresen 14k · 3 months ago
22 votes0 answers3.6k views
Would you accept 98.8% on liraglutide from BCH without a content assay?

Conditions: 98.8% · liraglutide · BCH. 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 coring_risk 17k · 5 months ago
21 votes2 answers36k views
How much of the gross mass of a 8 mg orforglipron vial is actually peptide?

Numbers first: 8 mg · orforglipron. 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 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
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 ines_delacruz 16k · 2.1 years ago
21 votes 5 answers34k views
Why did two SGN lots of retatrutide differ on content assay?

What I have: SGN · retatrutide. I have a result I cannot explain, and I would rather diagnose it than guess. I have checked the obvious explanations and eliminated…

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 pip_okonjo 11k · 20 months ago
21 votes 3 answers29k views
What counter-ion should I expect on an MKM survodutide lot?

The specifics, since they change the answer: MKM · 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 ayo_fadipe 19k · 19 months ago
21 votes2 answers22k views
Does mazdutide adsorb measurably to the vial wall at 6.67 mg/mL?

Details up front: mazdutide · 6.67 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 zainab_mustafa 16k · 2.0 years ago
21 votes 4 answers19k views
How does reference-standard error propagate into a retatrutide content figure?

The method section is present, which is unusual enough that I want to make use of it. The units are where I keep going wrong, so please be explicit about them. I have…

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 Dr_Wren_Halliday 40k · 11 months ago
21 votes 5 answers19k views
What does peptide mapping add for survodutide that a purity figure does not?

For reference: peptide mapping · survodutide. The comparison I want does not seem to exist anywhere in a form I can evaluate. I have read the arguments for each and…

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 ekaterina_volk 16k · 7 months ago
21 votes 4 answers18k views
Would you accept 98.2% on ecnoglutide from SWB without a content assay?

The particulars: 98.2% · ecnoglutide · SWB. 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 fibre_or_fragment 12k · 2.3 years ago
21 votes5 answers17k views
Does an in-house standard invalidate a content result?

I have both a purity figure and a content figure, which is why the discrepancy is visible. I suspect the usual explanation for this is wrong, or at least incomplete.…

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 shear_at_the_front 15k · 21 months ago
21 votes5 answers17k views
Does dimerisation of a GLP-1 receptor agonist at minus 80 °C show up as a loss of content or of purity?

Stated plainly: dimerisation · a GLP-1 receptor agonist · minus 80 °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 gradient_slope 41k · 8 months ago
21 votes 5 answers16k views
Is a sterility test worth paying for on top of a purity figure for dulaglutide?

Numbers first: a sterility test · dulaglutide. 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…

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 amara_nwachukwu 41k · 12 months ago
21 votes 4 answers14k views
What counter-ion should I expect on a QST liraglutide lot?

Concretely: QST · liraglutide. I would like to know the limits of what can be inferred from this. What I am trying to avoid is over-reading a single result, which 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 two_point_four 14k · 4 months ago
21 votes 2 answers13k views
Does fibrillation of survodutide at 2–8 °C show up as a loss of content or of purity?

For reference: fibrillation · survodutide · 2–8 °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 bufferline42 49k · 23 months ago
21 votes5 answers12k views
How does reference-standard error propagate into a dulaglutide content figure?

I am comparing a supplier certificate against an independent result on the same lot. I have worked this out and I would like someone to find the error, because 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 noor_alhassan 15k · 3 months ago
21 votes 5 answers11k views
How does reference-standard error propagate into a GLP-1 receptor agonist content figure?

I have the report as a PDF with the chromatogram on page two, so I can quote specifics. 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 ravi_pillai 16k · 10 months ago
21 votes0 answers9.7k views
Would you accept 98.2% on liraglutide from ERP without a content assay?

The case in front of me: 98.2% · liraglutide · ERP. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will follow the plan…

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 shear_at_the_front 15k · 10 months ago
21 votes5 answers8.4k views
How much of the gross mass of a 40 mg tirzepatide vial is actually peptide?

The case in front of me: 40 mg · tirzepatide. I want the working, not the result — I need to be able to redo it with different numbers. I care about the precision as…

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 fibre_or_fragment 12k · 2 months ago
21 votes0 answers7.1k views
Would you accept 98.2% on mazdutide from QST without a content assay?

Stated plainly: 98.2% · mazdutide · QST. I am trying to build something sustainable rather than something thorough that I will abandon. I have already decided the…

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_Jonas_Halvorsen 41k · 10 months ago
21 votes 1 answer7k views
What counter-ion should I expect on an MKM ecnoglutide lot?

For reference: MKM · ecnoglutide. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I am reasonably comfortable 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 drawn_and_capped 15k · 6 months ago
21 votes 4 answers6.9k views
What makes something a "certified reference material", and why is my content result only as good as the standard?

Every explanation of quantitative HPLC I have read says the result is traceable to the reference standard, and then moves on as though that settles it. I want to open…

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
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
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
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 lukas_sedlacek 17k · 16 months ago
21 votes 5 answers6.5k views
Is a residual-solvent screen worth paying for on top of a purity figure for mazdutide?

Stated plainly: 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…

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 cap_the_luer 15k · 2 months ago
21 votes0 answers6k views
Does retatrutide adsorb measurably to the vial wall at 3.33 mg/mL?

Setup, so nobody has to ask: retatrutide · 3.33 mg/mL. I have worked this out and I would like someone to find the error, because I suspect there is one. My working…

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 grainne_ahearn 13k · 3 months ago