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content-assay

Page 4 of 20 · 476 questions tagged content-assay.

476 questions · sorted by votes · page 4 of 20

30 votes 2 answers38k views
Does racemisation of retatrutide at 40 °C show up as a loss of content or of purity?

What I have: racemisation · retatrutide · 40 °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,…

908 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…

476 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…

833 questions
retatrutide
retatrutide

An investigational GLP-1, GIP and glucagon receptor tri-agonist, studied in the TRIUMPH programme. Not approved anywhere. Use this tag for…

251 questions
asked by second_lot 9.4k · 2.0 years ago
30 votes 2 answers30k views
How do I check that two BCH lots of mazdutide agree on content assay?

What I am working with: BCH · mazdutide. 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…

910 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
mazdutide
mazdutide

A GLP-1 and glucagon receptor dual agonist developed primarily in China, with a distinct dose range and a fast-moving publication record.…

237 questions
asked by colm_dunphy 8.2k · 14 months ago
30 votes 5 answers30k views
Does mazdutide adsorb measurably to the vial wall at 1 mg/mL?

Numbers first: mazdutide · 1 mg/mL. This should be a straightforward calculation and I keep getting two different answers. The numbers are arbitrary; the method is…

peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

908 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…

476 questions
storage
storage

Storage conditions and their evidence base: minus twenty degrees for powder, refrigerated for solution, protection from light, and what the…

701 questions
mazdutide
mazdutide

A GLP-1 and glucagon receptor dual agonist developed primarily in China, with a distinct dose range and a fast-moving publication record.…

237 questions
asked by Dr_Wren_Halliday 19k · 2.3 years ago
30 votes 5 answers29k views
What does a residual-solvent screen add for cagrilintide that a purity figure does not?

Setup, so nobody has to ask: a residual-solvent screen · cagrilintide. I suspect the honest answer is that it depends, in which case I would like to know on what.…

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…

476 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…

833 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…

771 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
amylin
amylin

Amylin and its analogues, most prominently cagrilintide, as a satiety mechanism orthogonal to incretin signalling. Includes the pharmacology of…

237 questions
asked by threadlock7 19k · 9 months ago
30 votes5 answers16k views
How do I check that two KP lots of orforglipron agree on content assay?

The particulars: KP · orforglipron. I have a result I cannot explain, and I would rather diagnose it than guess. I have checked the obvious explanations 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…

910 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
orforglipron
orforglipron

A non-peptide, orally bioavailable small-molecule GLP-1 receptor agonist studied in the ATTAIN programme. It is not a peptide, which changes…

219 questions
asked by fib4_reader 24k · 15 months ago
30 votes0 answers14k views
Would you accept 96.4% on dulaglutide from MKM without a content assay?

Numbers first: 96.4% · dulaglutide · MKM. 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…

833 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
dulaglutide
dulaglutide

A once-weekly GLP-1 receptor agonist built on an Fc fusion rather than fatty-acid acylation. Use this tag for questions about the fusion-protein…

200 questions
asked by otto_brenner 12k · 2.0 years ago
29 votes 5 answers48k views
Does dimerisation of cagrilintide at room temperature show up as a loss of content or of purity?

The specifics, since they change the answer: dimerisation · cagrilintide · room temperature. I keep seeing this stated as a fact with no explanation attached, and…

peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

908 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…

476 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…

833 questions
amylin
amylin

Amylin and its analogues, most prominently cagrilintide, as a satiety mechanism orthogonal to incretin signalling. Includes the pharmacology of…

237 questions
asked by stopper_core 28k · 19 months ago
29 votes5 answers41k views
How do I check that two QST lots of liraglutide agree on content assay?

Concretely: QST · liraglutide. 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 this is…

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…

910 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
liraglutide
liraglutide

A once-daily GLP-1 receptor agonist and the compound that established the class. Still relevant for its shorter half-life, its paediatric and…

235 questions
asked by Dr_Hanne_Solberg 36k · 23 months ago
29 votes3 answers28k views
How do I check that two CPC lots of tirzepatide agree on content assay?

The case in front of me: CPC · 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…

910 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
tirzepatide
tirzepatide

A dual GIP and GLP-1 receptor agonist. Questions here cover the SURPASS and SURMOUNT programmes, the practical differences from a pure GLP-1…

370 questions
asked by unit_math 6.2k · 17 months ago
29 votes4 answers25k views
How much of the gross mass of a 10 mg liraglutide vial is actually peptide?

The case in front of me: 10 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…

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…

476 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…

51 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…

88 questions
liraglutide
liraglutide

A once-daily GLP-1 receptor agonist and the compound that established the class. Still relevant for its shorter half-life, its paediatric and…

235 questions
asked by bridget_nyathi 12k · 2.2 years ago
29 votes 5 answers24k views
Does a large published testing history at QSC imply lot consistency?

The lot number on the vial matches the certificate, which at least rules out the easy problem. I keep seeing this stated as a fact with no explanation attached, 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…

910 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 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…

476 questions
asked by mira_sundqvist 7.1k · 16 months ago
29 votes0 answers18k views
Does a large published testing history at MKM imply lot consistency?

I have both a purity figure and a content figure, which is why the discrepancy is visible. I would like the mechanism, because I want to be able to reason about 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…

910 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 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…

476 questions
asked by loss_on_drying 40k · 9 months ago
29 votes5 answers17k views
Does racemisation of dulaglutide at minus 20 °C show up as a loss of content or of purity?

Details up front: racemisation · dulaglutide · minus 20 °C. 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,…

908 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…

476 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…

833 questions
dulaglutide
dulaglutide

A once-weekly GLP-1 receptor agonist built on an Fc fusion rather than fatty-acid acylation. Use this tag for questions about the fusion-protein…

200 questions
asked by fresh_bac 9.7k · 9 months ago
29 votes 5 answers13k views
Would you accept 97.1% on liraglutide from BCH without a content assay?

Conditions: 97.1% · liraglutide · BCH. 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…

833 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
liraglutide
liraglutide

A once-daily GLP-1 receptor agonist and the compound that established the class. Still relevant for its shorter half-life, its paediatric and…

235 questions
asked by kelvin_lam 7.6k · 14 months ago
29 votes 5 answers13k views
Would you accept 98.8% on orforglipron from GL Biochem without a content assay?

Numbers first: 98.8% · orforglipron · GL Biochem. 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…

833 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
orforglipron
orforglipron

A non-peptide, orally bioavailable small-molecule GLP-1 receptor agonist studied in the ATTAIN programme. It is not a peptide, which changes…

219 questions
asked by j_wierzbicki 69k · 8 months ago
29 votes 5 answers12k views
How do I check that two SWB lots of dulaglutide agree on content assay?

For reference: SWB · dulaglutide. 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…

910 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
dulaglutide
dulaglutide

A once-weekly GLP-1 receptor agonist built on an Fc fusion rather than fatty-acid acylation. Use this tag for questions about the fusion-protein…

200 questions
asked by thabo_maseko 28k · 15 months ago
29 votes 1 answer7.9k views
Does a GLP-1 receptor agonist adsorb measurably to the vial wall at 2.5 mg/mL?

Details up front: a GLP-1 receptor agonist · 2.5 mg/mL. This should be a straightforward calculation and I keep getting two different answers. The numbers are…

peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

908 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…

476 questions
storage
storage

Storage conditions and their evidence base: minus twenty degrees for powder, refrigerated for solution, protection from light, and what the…

701 questions
asked by swab_and_wait 13k · 13 months ago
28 votes 5 answers46k views
What counter-ion should I expect on a KP retatrutide lot?

Concretely: KP · retatrutide. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone else’s interpretation…

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…

88 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…

833 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…

476 questions
retatrutide
retatrutide

An investigational GLP-1, GIP and glucagon receptor tri-agonist, studied in the TRIUMPH programme. Not approved anywhere. Use this tag for…

251 questions
asked by net_peptide 12k · 20 months ago
28 votes 5 answers45k views
Does hydrolysis of orforglipron at 40 °C show up as a loss of content or of purity?

What I have: hydrolysis · orforglipron · 40 °C. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware this may have a boring answer. I…

peptide-stability
peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength,…

908 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…

476 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…

833 questions
orforglipron
orforglipron

A non-peptide, orally bioavailable small-molecule GLP-1 receptor agonist studied in the ATTAIN programme. It is not a peptide, which changes…

219 questions
asked by marta_okonkwo 190k · 2.2 years ago
28 votes5 answers39k views
Would you accept 99.1% on semaglutide from SGN without a content assay?

The specifics, since they change the answer: 99.1% · semaglutide · SGN. I would like to define my thresholds before I have a result, for obvious reasons. I want a…

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…

833 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
semaglutide
semaglutide

A GLP-1 receptor agonist with a fatty-acid-acylated backbone and a roughly one-week half-life, marketed for type 2 diabetes and for weight…

470 questions
asked by seven_day_half 31k · 2.2 years ago
28 votes 5 answers24k views
What counter-ion should I expect on a BCH cagrilintide lot?

The specifics, since they change the answer: BCH · cagrilintide. I have read the primary source rather than the summary, which has left me with more questions. 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…

88 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…

833 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…

476 questions
amylin
amylin

Amylin and its analogues, most prominently cagrilintide, as a satiety mechanism orthogonal to incretin signalling. Includes the pharmacology of…

237 questions
asked by eighty_six_hours 20k · 7 months ago
28 votes 5 answers22k views
How do I check that two QST lots of oral semaglutide agree on content assay?

For reference: QST · oral semaglutide. 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…

910 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
oral-glp1
oral-glp1

Oral routes for GLP-1 receptor agonism: peptide formulations rescued by absorption enhancers such as SNAC, and true small molecules that need no…

219 questions
asked by aine_mulcahy 28k · 15 months ago
28 votes5 answers11k views
Why does compounded a GLP-1 receptor agonist potency vary between pharmacies?

Costs, fees and monitoring all included, I am trying to compare like with like. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware…

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…

476 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…

771 questions
asked by sinead_gaffney 28k · 10 months ago
28 votes0 answers7.9k views
Would you accept 98.4% on oral semaglutide from BCH without a content assay?

Conditions: 98.4% · oral semaglutide · 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…

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…

833 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
oral-glp1
oral-glp1

Oral routes for GLP-1 receptor agonism: peptide formulations rescued by absorption enhancers such as SNAC, and true small molecules that need no…

219 questions
asked by olu_babatunde 6.2k · 9 months ago