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content-assay

Page 4 of 19 · 438 questions tagged content-assay.

438 questions · sorted by votes · page 4 of 19

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…

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 loss_on_drying 47k · 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,…

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 fresh_bac 13k · 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…

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 kelvin_lam 11k · 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…

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 j_wierzbicki 45k · 8 months ago
29 votes 5 answers12k views
Why did two SWB lots of dulaglutide differ on content assay?

Numbers first: 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…

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 thabo_maseko 20k · 15 months ago
28 votes 5 answers46k views
What counter-ion should I expect on a KP retatrutide lot?

Details up front: 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…

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
lc-ms
lc-ms

Liquid chromatography coupled to mass spectrometry: separation and identification in one run, and the method of choice when you need to know not…

14 questions
asked by net_peptide 16k · 20 months 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…

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 seven_day_half 16k · 2.2 years ago
28 votes 5 answers24k views
What counter-ion should I expect on a BCH cagrilintide lot?

Setup, so nobody has to ask: BCH · cagrilintide. 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 eighty_six_hours 16k · 7 months ago
28 votes 5 answers22k views
Why did two QST lots of oral semaglutide differ on content assay?

Conditions: 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…

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 aine_mulcahy 35k · 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…

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 sinead_gaffney 14k · 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…

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 olu_babatunde 14k · 9 months ago
27 votes 5 answers41k views
What counter-ion should I expect on an HJ liraglutide lot?

The case in front of me: HJ · 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…

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 sinead_gaffney 14k · 2.0 years ago
27 votes 5 answers34k views
Does dulaglutide adsorb measurably to the vial wall at 8 mg/mL?

Stated plainly: dulaglutide · 8 mg/mL. 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 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 esben_lykke 15k · 2.0 years ago
27 votes 5 answers30k views
Does aspartimide formation of liraglutide at 40 °C show up as a loss of content or of purity?

Conditions: aspartimide formation · liraglutide · 40 °C. This is one of those things that everyone repeats and nobody derives. This matters practically, not just…

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 gel_pack_warm 13k · 20 months ago
27 votes 5 answers30k views
Why did two KP lots of dulaglutide differ on content assay?

What I have: KP · dulaglutide. 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 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
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 rae_oyelowo 21k · 16 months ago
27 votes 5 answers28k views
Does tirzepatide adsorb measurably to the vial wall at 2.5 mg/mL?

The specifics, since they change the answer: tirzepatide · 2.5 mg/mL. I would rather understand the derivation than memorise the outcome. Two people I asked gave two…

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 k_szabo 45k · 9 months ago
27 votes 5 answers25k views
Does a large published testing history at BCH 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…

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 ahmed_zerouali 19k · 10 months ago
27 votes 3 answers24k views
What does peptide mapping add for ecnoglutide that a purity figure does not?

The particulars: peptide mapping · ecnoglutide. 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 pk_curve 12k · 13 months ago
27 votes 5 answers23k views
Is an HPLC purity test worth paying for on top of a purity figure for retatrutide?

Numbers first: an HPLC purity test · retatrutide. 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 ahmed_zerouali 19k · 7 months ago
27 votes 3 answers23k views
Does oral semaglutide adsorb measurably to the vial wall at 10 mg/mL?

The particulars: oral semaglutide · 10 mg/mL. I would rather understand the derivation than memorise the outcome. Two people I asked gave two answers that differ by a…

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 siobhan_deasy 16k · 16 months ago
27 votes 5 answers22k views
What does an HPLC purity test add for retatrutide that a purity figure does not?

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

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 elke_brunner 14k · 8 months ago
27 votes 5 answers21k views
What counter-ion should I expect on an SWB retatrutide lot?

Numbers first: SWB · retatrutide. 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 ekaterina_volk 16k · 7 months ago
27 votes5 answers14k views
Why did two WXT lots of mazdutide differ on content assay?

What I am working with: WXT · mazdutide. I noticed this today and I have not touched anything since, in case the state is diagnostic. I have not discarded anything…

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 tobias_reint 19k · 16 months ago
27 votes5 answers13k views
What counter-ion should I expect on a QST tirzepatide lot?

The case in front of me: QST · tirzepatide. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if 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 nkem_obiora 46k · 10 months ago