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content-assay

Page 9 of 19 · 438 questions tagged content-assay.

438 questions · sorted by votes · page 9 of 19

20 votes 5 answers24k views
Does aspartimide formation of tirzepatide at 37 °C show up as a loss of content or of purity?

Conditions: aspartimide formation · tirzepatide · 37 °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 anders_vestby 17k · 16 months ago
20 votes5 answers23k views
Does fibrillation of semaglutide at room temperature show up as a loss of content or of purity?

The particulars: fibrillation · semaglutide · room temperature. I would like the mechanism, because I want to be able to reason about the cases nobody has written…

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 hana_petrikova 19k · 11 months ago
20 votes 5 answers22k views
How much of the gross mass of a 20 mg mazdutide vial is actually peptide?

Stated plainly: 20 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 it seems…

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 olu_babatunde 14k · 20 months ago
20 votes0 answers22k views
Why does my content assay disagree with the label by more than purity would allow?

The method section is present, which is unusual enough that I want to make use of it. I noticed this today and I have not touched anything since, in case the state 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 pieter_maas 22k · 2.2 years ago
20 votes 5 answers20k views
What is traceability, in practical terms, for a reference material?

The method section is present, which is unusual enough that I want to make use of it. I keep seeing this stated as a fact with no explanation attached, and…

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
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
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 · 23 months ago
20 votes 5 answers20k views
What counter-ion should I expect on a GL Biochem ecnoglutide lot?

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

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 cake_intact 18k · 14 months ago
20 votes 5 answers11k views
Would you accept 96.4% on cagrilintide from CPC without a content assay?

What I am working with: 96.4% · cagrilintide · CPC. I am trying to build something sustainable rather than something thorough that I will abandon. I have already…

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 anja_hellstrom 13k · 3 months ago
20 votes 5 answers11k views
How much of the gross mass of a 60 mg cagrilintide vial is actually peptide?

Setup, so nobody has to ask: 60 mg · cagrilintide. I have worked this out and I would like someone to find the error, because I suspect there is one. My working so…

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 seamus_brady 17k · 7 months ago
20 votes5 answers8.9k views
Does oxidation of liraglutide at 30 °C show up as a loss of content or of purity?

Conditions: oxidation · liraglutide · 30 °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 cap_the_luer 15k · 3 months ago
20 votes 2 answers8.4k views
Does a large published testing history at GGPeps imply lot consistency?

This is my second independent submission on material from the same supplier. I understand the observation; what I do not understand is the mechanism behind it. I have…

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 bounty_hunter_q 18k · 2 months ago
20 votes 3 answers6.2k views
How is a quantitative content assay actually run, and how much should I trust the mg figure?

I am about to pay for quantification on a group of vials rather than just purity, having read enough here to understand why. Before I do, I want to know what I am…

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
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
hplc
hplc

Reverse-phase high-performance liquid chromatography, the workhorse purity method. Column chemistry, mobile-phase choice, gradient slope,…

466 questions
janoshik
janoshik

Janoshik Analytical, an independent third-party testing laboratory widely used by this community for HPLC purity, identity and quantified content…

34 questions
medutest
medutest

Medutest, one of four independent testing and verification services referenced throughout this site. Use this tag for its methods, its report…

14 questions
asked by p_mkhize 41k · 6 months ago
20 votes0 answers5.1k views
Would you accept 98.4% on tirzepatide from BCH without a content assay?

Concretely: 98.4% · tirzepatide · 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 u100_marks 38k · 20 days ago
20 votes 5 answers4.8k views
What does a quantified content assay add for tirzepatide that a purity figure does not?

The case in front of me: a quantified content assay · tirzepatide. 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 grainne_ahearn 13k · 3 months ago
20 votes 2 answers2.8k views
Why did two FGP lots of a GLP-1 receptor agonist differ on content assay?

Stated plainly: FGP · a GLP-1 receptor agonist. This is not behaving the way I expected and I want to understand the discrepancy before I act on it. I have…

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 swirl_dont_shake 19k · 22 days ago
19 votes5 answers48k views
Is a sterility test worth paying for on top of a purity figure for retatrutide?

Details up front: a sterility test · retatrutide. 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…

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 hana_petrikova 19k · 2.2 years ago
19 votes5 answers46k views
Does a large published testing history at SWB imply lot consistency?

This is my second independent submission on material from the same supplier. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware…

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 Dr_Ravi_Selvarajah 42k · 2.1 years ago
19 votes5 answers36k views
Why does compounded mazdutide potency vary between pharmacies?

I have been through one internal appeal already and would like to do the next one properly. I suspect the usual explanation for this is wrong, or at least incomplete.…

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 tyndall_haze 48k · 2.2 years ago
19 votes 5 answers33k views
Does a large published testing history at WWB imply lot consistency?

This is my second independent submission on material from the same supplier. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware…

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 bridget_nyathi 16k · 19 months ago
19 votes 5 answers25k views
What counter-ion should I expect on a GL Biochem survodutide lot?

The particulars: GL Biochem · survodutide. I want to understand what this actually establishes, as opposed to what it is being used to imply. My concern is that I am…

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 rosa_mendieta 13k · 2.1 years ago
19 votes 5 answers21k views
What does "identity confirmed" mean without a quantified content figure?

I am comparing a supplier certificate against an independent result on the same lot. I would like help reading this properly rather than being told what conclusion to…

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
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
mass-spec
mass-spec

Mass spectrometry for identity confirmation: electrospray ionisation, multiple charge states, monoisotopic versus average mass, deconvolution, and…

38 questions
asked by dermot_kiely 14k · 14 months ago
19 votes 5 answers20k views
What counter-ion should I expect on an ERP a GLP-1 receptor agonist lot?

Stated plainly: ERP · 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 zeynep_arslan 20k · 8 months ago
19 votes 5 answers14k views
Does deamidation of ecnoglutide at 30 °C show up as a loss of content or of purity?

The specifics, since they change the answer: deamidation · ecnoglutide · 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 Dr_Hanne_Solberg 40k · 9 months ago
19 votes 3 answers14k views
Does oral semaglutide adsorb measurably to the vial wall at 6.67 mg/mL?

The particulars: oral semaglutide · 6.67 mg/mL. I would like the arithmetic checked rather than the conclusion asserted. I have deliberately not used an online…

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 · 10 months ago
19 votes0 answers12k views
Is a Karl Fischer water content test worth paying for on top of a purity figure for liraglutide?

The case in front of me: a Karl Fischer water content test · liraglutide. I want to decide this in advance so that I am not deciding it under pressure later. Assume 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
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 anouk_desmet 18k · 13 months ago