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content-assay

Page 7 of 19 · 438 questions tagged content-assay.

438 questions · sorted by votes · page 7 of 19

23 votes 4 answers26k views
What does a quantified content assay add for liraglutide that a purity figure does not?

The case in front of me: a quantified content assay · liraglutide. I would like the axes of comparison first and the recommendation second. I have tried the first…

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 cake_collapsed 13k · 2.4 years ago
23 votes5 answers22k views
How does reference-standard error propagate into a semaglutide content figure?

I am comparing a supplier certificate against an independent result on the same lot. 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 mateo_iglesias 16k · 9 months ago
23 votes0 answers19k views
How does the reference standard error propagate into my 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 ivo_paunovic 15k · 13 months ago
23 votes2 answers16k views
Would you accept 97.6% on a GLP-1 receptor agonist from HJ without a content assay?

Setup, so nobody has to ask: 97.6% · a GLP-1 receptor agonist · HJ. I am trying to build something sustainable rather than something thorough that I will abandon. 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 juan_esquivel 14k · 14 months ago
23 votes 5 answers15k views
Does cagrilintide adsorb measurably to the vial wall at 2.5 mg/mL?

Numbers first: cagrilintide · 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 deamidation_watch 43k · 10 months ago
23 votes5 answers14k views
Does deamidation of survodutide at 25 °C show up as a loss of content or of purity?

For reference: deamidation · survodutide · 25 °C. I understand the observation; what I do not understand is the mechanism behind it. I have read the two review…

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 samir_bennani 13k · 15 months ago
23 votes 3 answers14k views
Does hydrolysis of dulaglutide at 4 °C show up as a loss of content or of purity?

Details up front: hydrolysis · dulaglutide · 4 °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 halvard_ness 42k · 6 months ago
23 votes 5 answers12k views
Does racemisation of orforglipron at 37 °C show up as a loss of content or of purity?

What I have: racemisation · orforglipron · 37 °C. I can predict the outcome but I cannot explain it, which means I will get the next case wrong. I would like to know…

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 coldbox9 13k · 3 months ago
23 votes 5 answers11k views
Why did two QST lots of tirzepatide differ on content assay?

Conditions: QST · tirzepatide. 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 seven_day_half 16k · 14 months ago
23 votes5 answers7.4k views
Is peptide mapping worth paying for on top of a purity figure for survodutide?

The particulars: peptide mapping · survodutide. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with explicit stopping…

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 tri_gly_ala 48k · 2 months ago
22 votes3 answers19k views
How much of the gross mass of a 5 mg a GLP-1 receptor agonist vial is actually peptide?

Stated plainly: 5 mg · a GLP-1 receptor agonist. The units are where I keep going wrong, so please be explicit about them. I have sanity-checked the order of…

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 Dr_Yusuf_Adeyemi 95k · 10 months ago
22 votes3 answers16k views
Why did two JEEP lots of orforglipron differ on content assay?

What I have: JEEP · 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 halvard_ness 42k · 7 months ago
22 votes5 answers13k views
How much of the gross mass of a 10 mg tirzepatide vial is actually peptide?

The case in front of me: 10 mg · tirzepatide. Please show the division. I want to check my own against yours. I would like the general form as well as the specific…

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 b_delacroix 48k · 4 months ago
22 votes 5 answers11k views
How much of the gross mass of a 4 mg semaglutide vial is actually peptide?

The specifics, since they change the answer: 4 mg · semaglutide. I would like the arithmetic checked rather than the conclusion asserted. I have deliberately not used…

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 pip_okonjo 11k · 2 months ago
22 votes 5 answers11k views
Why did two HJ lots of tirzepatide differ on content assay?

The case in front of me: HJ · tirzepatide. 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 coring_risk 17k · 10 months ago
22 votes 5 answers10k views
Does hydrolysis of retatrutide at 4 °C show up as a loss of content or of purity?

Details up front: hydrolysis · retatrutide · 4 °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 yuki_morishita 19k · 13 months ago
22 votes 5 answers8.3k views
Does aggregation of mazdutide at 30 °C show up as a loss of content or of purity?

Setup, so nobody has to ask: aggregation · mazdutide · 30 °C. The empirical answer seems settled. The explanation does not. If the honest answer is that nobody knows,…

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 anja_hellstrom 13k · 6 months ago
22 votes 5 answers8k views
How much of the gross mass of a 4 mg survodutide vial is actually peptide?

For reference: 4 mg · survodutide. I would rather understand the derivation than memorise the outcome. Two people I asked gave two answers that differ by a factor of…

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 pip_okonjo 11k · 37 days ago
22 votes 2 answers7.6k views
How much of the gross mass of a 40 mg oral semaglutide vial is actually peptide?

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

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
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 cold_lane 14k · 13 months ago
22 votes4 answers7.3k views
How much of the gross mass of a 60 mg mazdutide vial is actually peptide?

What I am working with: 60 mg · mazdutide. 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…

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 fresh_bac 13k · 38 days ago
22 votes2 answers7.3k views
What does a Karl Fischer water content test add for liraglutide that a purity figure does not?

Concretely: a Karl Fischer water content test · liraglutide. 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_Bram_Verhoeven 85k · 6 months ago
22 votes0 answers7.3k views
What counter-ion should I expect on a GGPeps semaglutide lot?

The specifics, since they change the answer: GGPeps · semaglutide. I want to understand what this actually establishes, as opposed to what it is being used to imply.…

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_Elias_Weiss 46k · 7 months ago
22 votes0 answers6.7k views
Does a large published testing history at JEEP imply lot consistency?

I have the report as a PDF with the chromatogram on page two, so I can quote specifics. I can predict the outcome but I cannot explain it, which means I will get 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
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 tyndall_haze 48k · 2 months ago
22 votes 5 answers5.4k views
Does hydrolysis of dulaglutide at 37 °C show up as a loss of content or of purity?

Numbers first: hydrolysis · dulaglutide · 37 °C. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware this may have a boring answer.…

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 pascal_thibault 13k · 4 months ago