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purity

Page 4 of 33 · 788 questions tagged purity.

788 questions · sorted by votes · page 4 of 33

34 votes5 answers50k views
How do I read an impurity table on a survodutide certificate against the 97.9% headline?

The case in front of me: survodutide · 97.9%. Please show the division. I want to check my own against yours. I would like the general form as well as the specific…

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
hplc
hplc

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

466 questions
asked by tobias_reint 19k · 20 months ago
34 votes 5 answers46k views
Is a 97.9% result from Medutest comparable to 98.8% from Janoshik?

Setup, so nobody has to ask: 97.9% · Medutest · 98.8% · Janoshik. Both of these get recommended confidently by different people, which suggests neither is obviously…

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
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
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
asked by ayo_fadipe 19k · 18 months ago
34 votes 5 answers43k views
What does a sterility test add for dulaglutide that a purity figure does not?

What I have: a sterility test · dulaglutide. I want to know what the trade-off actually is rather than which option is fashionable. I would rather have a defensible…

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 rota_site 55k · 17 months ago
34 votes 5 answers40k views
Why would Janoshik report 99.1% where the supplier certificate says something higher?

Setup, so nobody has to ask: Janoshik · 99.1%. I noticed this today and I have not touched anything since, in case the state is diagnostic. I have not discarded…

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
hplc
hplc

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

466 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
asked by nynke_dekker 18k · 17 months ago
34 votes5 answers40k views
Why would VendorInvestigate report 97.6% where the supplier certificate says something higher?

The particulars: VendorInvestigate · 97.6%. An unexpected observation, and I would like a differential rather than reassurance. The conditions were within what I…

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
hplc
hplc

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

466 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
asked by priya_menon 11k · 17 months ago
34 votes 5 answers39k views
How does semaglutide behave on a C4 column compared to liraglutide?

Concretely: semaglutide · a C4 column · liraglutide. These are treated as interchangeable and I do not think they are. If both are acceptable I would like to know…

hplc
hplc

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

466 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
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
asked by fib4_reader 35k · 2.1 years ago
34 votes5 answers37k views
Would you accept 97.9% on tirzepatide from ERP without a content assay?

Concretely: 97.9% · tirzepatide · ERP. 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 down,…

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 harriet_lonsdale 14k · 2.0 years ago
34 votes0 answers36k views
How does reference-standard error propagate into a mazdutide content figure?

This is my second independent submission on material from the same supplier. This should be a straightforward calculation and I keep getting two different answers.…

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
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 one_ml_bac 12k · 20 months ago
34 votes 5 answers35k views
How does reference-standard error propagate into an orforglipron content figure?

I am comparing a supplier certificate against an independent result on the same lot. The units are where I keep going wrong, so please be explicit about them. I have…

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
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 stopper_core 50k · 23 months ago
34 votes0 answers32k views
What does 98.8% purity on a C4 column actually tell me about a dulaglutide vial?

Conditions: 98.8% · a C4 column · dulaglutide. 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…

hplc
hplc

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

466 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 ivo_paunovic 15k · 22 months ago
34 votes 5 answers28k views
How does retatrutide behave on a C18 column compared to cagrilintide?

What I am working with: retatrutide · a C18 column · cagrilintide. I suspect the honest answer is that it depends, in which case I would like to know on what. Assume…

hplc
hplc

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

466 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
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
asked by helena_vidmar 18k · 2.2 years ago
34 votes 5 answers25k views
Does a formic acid mobile phase change the purity number I get for cagrilintide on a wide-pore C18 column?

Setup, so nobody has to ask: a formic acid mobile phase · cagrilintide · a wide-pore C18 column. The empirical answer seems settled. The explanation does not. If the…

hplc
hplc

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

466 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
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
asked by s_bhattacharya 42k · 23 months ago
34 votes 4 answers21k views
How can a vial be 99% pure by HPLC and still contain under 7 mg of a nominal 10 mg?

I sent two vials from two different batches, both labelled 10 mg semaglutide, for independent testing and asked for purity and quantification on each. The results…

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
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
hplc
hplc

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

466 questions
dosing-math
dosing-math

The arithmetic itself: milligrams to millilitres to insulin units, concentration after reconstitution, dose per draw, and vial-days per vial. Show…

811 questions
asked by seamus_brady 17k · 18 months ago
34 votes5 answers13k views
Why would Medutest report 98.4% where the supplier certificate says something higher?

Details up front: Medutest · 98.4%. 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,…

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
hplc
hplc

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

466 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
asked by jonas_ekstrom 18k · 14 months ago
33 votes 5 answers36k views
Would you accept 96.8% on ecnoglutide from WWB without a content assay?

The specifics, since they change the answer: 96.8% · ecnoglutide · WWB. I am at the decision point and I would rather think it through than improvise. I would rather…

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 · 11 months ago
33 votes5 answers36k views
Does deamidation of ecnoglutide at 37 °C show up as a loss of content or of purity?

For reference: deamidation · ecnoglutide · 37 °C. I understand the observation; what I do not understand is the mechanism behind it. I have read the two review…

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 per_haugen 18k · 18 months ago
33 votes 5 answers32k views
Why would VendorInvestigate report 95.2% where the supplier certificate says something higher?

The specifics, since they change the answer: VendorInvestigate · 95.2%. Something has gone wrong and I would like to know how badly before I decide what to do.…

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
hplc
hplc

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

466 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
asked by nils_karlberg 13k · 12 months ago
33 votes 5 answers27k views
Would you accept 99.4% on dulaglutide from QYB without a content assay?

Details up front: 99.4% · 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…

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 marta_okonkwo 87k · 18 months ago
33 votes5 answers24k views
What does a 97.6% purity with a date of analysis attached let me conclude?

Conditions: 97.6% · date of analysis. 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,…

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
hplc
hplc

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

466 questions
asked by juan_esquivel 14k · 14 months ago
33 votes 5 answers23k views
Is 97.1% a realistic purity ceiling for retatrutide given its chain length?

What I have: 97.1% · retatrutide. This should be a straightforward calculation and I keep getting two different answers. The numbers are arbitrary; the method is what…

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
hplc
hplc

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

466 questions
peptide-mapping
peptide-mapping

Enzymatic digestion followed by LC-MS/MS to confirm sequence rather than just mass. The method that catches a scrambled sequence or a D-amino-acid…

83 questions
asked by triple_agonist_q 37k · 11 months ago
33 votes2 answers16k views
How do I read an impurity table on an ecnoglutide certificate against the 99.1% headline?

Conditions: ecnoglutide · 99.1%. 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…

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
hplc
hplc

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

466 questions
asked by esben_lykke 15k · 13 months ago
32 votes 5 answers46k views
What does a 99.1% purity with a chromatogram attached let me conclude?

The particulars: 99.1% · chromatogram. I want to understand what this actually establishes, as opposed to what it is being used to imply. My concern is that I am…

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
hplc
hplc

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

466 questions
asked by eighty_six_hours 16k · 2.1 years ago
32 votes 5 answers43k views
How do I read a GLP-1 receptor agonist chromatogram from Janoshik beyond the headline number?

Details up front: a GLP-1 receptor agonist · Janoshik. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at…

hplc
hplc

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

466 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 aine_mulcahy 35k · 2.2 years ago
32 votes 5 answers36k views
What counter-ion should I expect on a GGPeps ecnoglutide lot?

For reference: GGPeps · ecnoglutide. I want to understand what this actually establishes, as opposed to what it is being used to imply. My concern is that I am being…

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 jana_horakova 15k · 2.1 years ago