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content-assay

Page 10 of 19 · 438 questions tagged content-assay.

438 questions · sorted by votes · page 10 of 19

19 votes 5 answers11k views
What does an HPLC purity test add for dulaglutide that a purity figure does not?

What I have: an HPLC purity test · dulaglutide. I have used one of these for a while and I am considering switching, which requires a reason. What I care about is…

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 dermot_kiely 14k · 12 months ago
19 votes 5 answers11k views
Does fibrillation of semaglutide at 40 °C show up as a loss of content or of purity?

For reference: fibrillation · semaglutide · 40 °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 loss_on_drying 47k · 12 months ago
19 votes 1 answer10k views
Would you accept 96.4% on orforglipron from QYB without a content assay?

Numbers first: 96.4% · orforglipron · QYB. 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 rukhsana_iqbal 14k · 7 months ago
19 votes2 answers9.4k views
Does a GLP-1 receptor agonist adsorb measurably to the vial wall at 1 mg/mL?

Numbers first: a GLP-1 receptor agonist · 1 mg/mL. I can do the algebra. I am not confident about the conversion factors. If there is a standard way to lay this out,…

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 tare_and_weigh 18k · 15 months ago
19 votes 5 answers8.4k views
Would you accept 98.2% on cagrilintide from QST without a content assay?

Stated plainly: 98.2% · cagrilintide · QST. I would like to set this up properly once, rather than adjust it repeatedly. My budget is real but not tight, and my…

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 sunniva_dahl 11k · 14 days ago
18 votes 5 answers27k views
Would you accept 99.1% on mazdutide from QST without a content assay?

Setup, so nobody has to ask: 99.1% · mazdutide · QST. 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 b_delacroix 48k · 2.1 years ago
18 votes5 answers27k views
Does ecnoglutide adsorb measurably to the vial wall at 5 mg/mL?

Concretely: ecnoglutide · 5 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 valentina_rossi 16k · 19 months ago
18 votes 5 answers24k views
How much of the gross mass of a 2.5 mg tirzepatide vial is actually peptide?

Conditions: 2.5 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 number, so I…

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 · 2.1 years ago
18 votes 5 answers21k views
What counter-ion should I expect on a KP orforglipron lot?

Details up front: KP · 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 tri_gly_ala 48k · 14 months ago
18 votes 5 answers17k views
Would you accept 97.1% on ecnoglutide from JEEP without a content assay?

The particulars: 97.1% · ecnoglutide · JEEP. 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 rota_site 55k · 7 months ago
18 votes 5 answers15k views
What does a quantified content assay add for oral semaglutide that a purity figure does not?

Conditions: a quantified content assay · oral semaglutide. I would like the axes of comparison first and the recommendation second. I have tried the first option 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 hana_petrikova 19k · 14 months ago
18 votes 5 answers14k views
Is a nine per cent content shortfall within any reasonable tolerance?

This is my second independent submission on material from the same supplier. I would like to define my thresholds before I have a result, for obvious reasons. I want…

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
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 birk_nordahl 20k · 8 months ago
18 votes0 answers14k views
Why does compounded survodutide potency vary between pharmacies?

The pharmacy is accredited and I have verified that on the accreditor register. This is one of those things that everyone repeats and nobody derives. This matters…

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 anja_hellstrom 13k · 2.2 years ago
18 votes 5 answers13k views
What counter-ion should I expect on a WXT a GLP-1 receptor agonist lot?

Stated plainly: WXT · a GLP-1 receptor agonist. I have read the primary source rather than the summary, which has left me with more questions. I understand 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 retest_please 13k · 9 months ago
18 votes5 answers12k views
Would you accept 96.8% on liraglutide from QSC without a content assay?

The case in front of me: 96.8% · liraglutide · QSC. 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 rune_thoresen 14k · 19 months ago
18 votes2 answers11k views
How much of the gross mass of a 2.5 mg oral semaglutide vial is actually peptide?

Concretely: 2.5 mg · oral semaglutide. Please show the division. I want to check my own against yours. I would like the general form as well as the specific number,…

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 tri_gly_ala 48k · 9 months ago
18 votes0 answers7.3k views
Does liraglutide adsorb measurably to the vial wall at 4 mg/mL?

The particulars: liraglutide · 4 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 ravi_pillai 16k · 5 months ago
18 votes0 answers5.2k views
Is an HPLC purity test worth paying for on top of a purity figure for orforglipron?

Numbers first: an HPLC purity test · orforglipron. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone can tell me…

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 ilaria_bertone 43k · 12 months ago
18 votes0 answers5.1k views
Does oxidation of liraglutide at 4 °C show up as a loss of content or of purity?

Concretely: oxidation · liraglutide · 4 °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 mira_sundqvist 19k · 4 months ago
17 votes5 answers35k views
Does a large published testing history at SGN imply lot consistency?

I have the report as a PDF with the chromatogram on page two, so I can quote specifics. I suspect the usual explanation for this is wrong, or at least incomplete. I…

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 klara_novotna 16k · 2.1 years ago
17 votes 5 answers34k views
Why does compounded liraglutide potency vary between pharmacies?

I have the plan documents and the written criteria, which took two calls to obtain. I understand the observation; what I do not understand is the mechanism behind it.…

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 Dr_Otto_Lindqvist 38k · 23 months ago
17 votes 5 answers30k views
Does deamidation of survodutide at 30 °C show up as a loss of content or of purity?

The specifics, since they change the answer: deamidation · survodutide · 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 ten_mg_vial 16k · 2.3 years ago
17 votes 5 answers29k views
Would you accept 98.2% on dulaglutide from SSA without a content assay?

What I have: 98.2% · dulaglutide · SSA. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone can tell me which work…

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 dermot_kiely 14k · 2.4 years ago
17 votes 5 answers21k views
Would you accept 99.1% on mazdutide from TFC without a content assay?

Setup, so nobody has to ask: 99.1% · mazdutide · TFC. 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 anouk_desmet 18k · 13 months ago