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content-assay

Page 17 of 19 · 438 questions tagged content-assay.

438 questions · sorted by votes · page 17 of 19

6 votes 2 answers14k views
Does oral semaglutide adsorb measurably to the vial wall at 4 mg/mL?

For reference: oral semaglutide · 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 jonas_ekstrom 18k · 23 months ago
6 votes 5 answers13k views
Would you accept 98.4% on dulaglutide from QYB without a content assay?

Numbers first: 98.4% · dulaglutide · 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 ines_delacruz 16k · 14 months ago
6 votes5 answers11k views
Does fibrillation of ecnoglutide at 37 °C show up as a loss of content or of purity?

The specifics, since they change the answer: fibrillation · ecnoglutide · 37 °C. I would like the mechanism, because I want to be able to reason about the cases…

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 v_ramaswamy 40k · 2.1 years ago
6 votes 4 answers9k views
Would you accept 98.2% on dulaglutide from GGPeps without a content assay?

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

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 sample_id 17k · 2.3 years ago
6 votes 5 answers8.8k views
Does hydrolysis of retatrutide at 37 °C show up as a loss of content or of purity?

Details up front: hydrolysis · retatrutide · 37 °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 two_point_four 14k · 16 months ago
6 votes5 answers8.2k views
What counter-ion should I expect on a QYB ecnoglutide lot?

The particulars: QYB · 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…

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 zeynep_arslan 20k · 22 months ago
6 votes5 answers6.3k views
What does an endotoxin test add for mazdutide that a purity figure does not?

What I am working with: an endotoxin test · mazdutide. Both of these get recommended confidently by different people, which suggests neither is obviously right. My…

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 ravenna_pace 13k · 10 months ago
6 votes 5 answers4.7k views
Why did two ERP lots of cagrilintide differ on content assay?

What I am working with: ERP · cagrilintide. This is not behaving the way I expected and I want to understand the discrepancy before I act on it. I have photographed…

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 label_claim 11k · 11 months ago
6 votes4 answers4k views
What does an endotoxin test add for a GLP-1 receptor agonist that a purity figure does not?

What I am working with: an endotoxin test · a GLP-1 receptor agonist. Both of these get recommended confidently by different people, which suggests neither 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 meniscus_film 34k · 22 days ago
5 votes5 answers27k views
How much of the gross mass of a 60 mg a GLP-1 receptor agonist vial is actually peptide?

Setup, so nobody has to ask: 60 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…

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 jana_horakova 15k · 2.0 years ago
5 votes 5 answers23k views
Would you accept 98.8% on tirzepatide from WXT without a content assay?

Conditions: 98.8% · tirzepatide · WXT. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in view and I would like 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 bea_forsberg 14k · 2.1 years ago
5 votes 5 answers13k views
Does survodutide adsorb measurably to the vial wall at 3.33 mg/mL?

Concretely: survodutide · 3.33 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…

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 fresh_bac 13k · 17 months ago
5 votes 5 answers8.6k views
How much of the gross mass of a 5 mg mazdutide vial is actually peptide?

What I am working with: 5 mg · mazdutide. The units are where I keep going wrong, so please be explicit about them. I have sanity-checked the order of magnitude 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
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 per_haugen 18k · 2.2 years ago
5 votes5 answers8.3k views
What counter-ion should I expect on a BCH a GLP-1 receptor agonist lot?

Stated plainly: BCH · a GLP-1 receptor agonist. I would like help reading this properly rather than being told what conclusion to reach. I have the full report…

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 tenth_of_a_unit 40k · 2.1 years ago
5 votes 2 answers4.9k views
Would you accept 99.1% on liraglutide from FGP without a content assay?

The case in front of me: 99.1% · liraglutide · FGP. 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 sample_id 17k · 6 months ago
5 votes0 answers4.8k views
Does surface adsorption to the vial wall lose measurable peptide?

I have the same lot stored correctly as a comparator, if a side-by-side test would help. I have worked this out and I would like someone to find the error, because 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 Dr_Idris_Coulibaly 40k · 15 months ago
5 votes4 answers4.6k views
Why did two BCH lots of a GLP-1 receptor agonist differ on content assay?

Stated plainly: BCH · a GLP-1 receptor agonist. I noticed this today and I have not touched anything since, in case the state is diagnostic. I have not discarded…

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 rania_haddad 17k · 5 months ago
5 votes5 answers4.1k views
Does mazdutide adsorb measurably to the vial wall at 4 mg/mL?

What I have: mazdutide · 4 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, I would rather…

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 kofi_mensah 12k · 10 months ago
4 votes 5 answers19k views
Does hydrolysis of dulaglutide at minus 20 °C show up as a loss of content or of purity?

Details up front: hydrolysis · dulaglutide · minus 20 °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 priya_menon 11k · 19 months ago
4 votes 4 answers13k views
What counter-ion should I expect on a QSC cagrilintide lot?

Setup, so nobody has to ask: QSC · cagrilintide. I would like help reading this properly rather than being told what conclusion to reach. I have the full report…

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 fresh_bac 13k · 15 months ago
4 votes5 answers11k views
What counter-ion should I expect on a CPC liraglutide lot?

Concretely: CPC · 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 orla_ferriter 47k · 9 months ago
4 votes5 answers10k views
Why does compounded tirzepatide potency vary between pharmacies?

I have the plan documents and the written criteria, which took two calls to obtain. I would like the mechanism, because I want to be able to reason about the cases…

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 wren_calloway 14k · 23 months ago
4 votes 5 answers5.1k views
Does aggregation of mazdutide at room temperature show up as a loss of content or of purity?

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

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 ravi_pillai 16k · 2 months ago
4 votes 5 answers4.6k views
How much of the gross mass of a 2.5 mg liraglutide vial is actually peptide?

Concretely: 2.5 mg · liraglutide. 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…

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 pieter_maas 22k · 11 months ago