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purity

Page 7 of 33 · 788 questions tagged purity.

788 questions · sorted by votes · page 7 of 33

30 votes 4 answers23k views
Is 98.8% a realistic purity ceiling for semaglutide given its chain length?

The particulars: 98.8% · semaglutide. I would like the arithmetic checked rather than the conclusion asserted. I have deliberately not used an online calculator…

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 teodora_ilic 15k · 2.3 years ago
30 votes 5 answers19k views
How do I reconcile 99.1% from Medutest with 96.4% from the supplier?

Stated plainly: 99.1% · Medutest · 96.4%. This is not behaving the way I expected and I want to understand the discrepancy before I act on it. I have photographed 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
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
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 pip_okonjo 11k · 15 months ago
30 votes 5 answers18k views
Is a 97.1% result from PeptideMeter comparable to 99.4% from Medutest?

The particulars: 97.1% · PeptideMeter · 99.4% · Medutest. I am trying to choose between two options that are usually discussed as though only one exists. I am not…

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 charge_state_3 39k · 14 months ago
30 votes5 answers15k views
What does 99.4% purity on a C8 column actually tell me about a liraglutide vial?

Numbers first: 99.4% · a C8 column · liraglutide. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear…

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 pk_curve 12k · 12 months ago
30 votes0 answers9.1k views
What does 98.8% purity on a C8 column actually tell me about a tirzepatide vial?

Numbers first: 98.8% · a C8 column · tirzepatide. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear…

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 j_wierzbicki 45k · 14 months ago
29 votes 5 answers58k views
How do I reconcile 99.4% from VendorInvestigate with 98.4% from the supplier?

Conditions: 99.4% · VendorInvestigate · 98.4%. I have two candidate explanations and no way to distinguish them. The same procedure has worked without incident…

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
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 two_two_micron 15k · 2.0 years ago
29 votes 5 answers53k views
What does a 96.8% purity with a date of analysis attached let me conclude?

Conditions: 96.8% · 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 triple_agonist_q 37k · 2.1 years ago
29 votes 5 answers46k views
How do I reconcile 99.4% from Medutest with 96.4% from the supplier?

Stated plainly: 99.4% · Medutest · 96.4%. I noticed this today and I have not touched anything since, in case the state is diagnostic. I have not discarded anything…

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
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 zainab_mustafa 16k · 19 months ago
29 votes 5 answers41k views
How does ecnoglutide behave on a C4 column compared to survodutide?

The case in front of me: ecnoglutide · a C4 column · survodutide. I would like the axes of comparison first and the recommendation second. I have tried the first…

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 teodora_ilic 15k · 2.3 years ago
29 votes5 answers31k views
How do I reconcile 99.1% from VendorInvestigate with 98.4% from the supplier?

The case in front of me: 99.1% · VendorInvestigate · 98.4%. I have two candidate explanations and no way to distinguish them. The same procedure has worked without…

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
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 jo_vandeberg 19k · 14 months ago
29 votes 5 answers28k views
Is a 96.8% result from PeptideMeter comparable to 99.4% from PeptideMeter?

The specifics, since they change the answer: 96.8% · PeptideMeter · 99.4% · PeptideMeter. I am trying to choose between two options that are usually discussed as…

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 nine_point_nine 45k · 18 months ago
29 votes 5 answers28k views
How do I reconcile 97.6% from Janoshik with 98.8% from the supplier?

Numbers first: 97.6% · Janoshik · 98.8%. 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…

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
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 cap_the_luer 15k · 18 months ago
29 votes 3 answers18k views
How do I reconcile 97.1% from Medutest with 96.8% from the supplier?

Setup, so nobody has to ask: 97.1% · Medutest · 96.8%. I noticed this today and I have not touched anything since, in case the state is diagnostic. I have not…

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
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 anja_hellstrom 13k · 20 months ago
29 votes 5 answers18k views
What does 95.2% purity on a C8 column actually tell me about a tirzepatide vial?

Numbers first: 95.2% · a C8 column · tirzepatide. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear…

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 anja_hellstrom 13k · 18 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
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
Is 97.9% a realistic purity ceiling for liraglutide given its chain length?

Conditions: 97.9% · liraglutide. 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 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
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 mateo_iglesias 16k · 15 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 answers38k views
Would peptide mapping distinguish oxidation from a synthesis impurity in cagrilintide?

The particulars: peptide mapping · oxidation · cagrilintide. I am trying to choose between two options that are usually discussed as though only one exists. I am not…

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
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
mass-spec
mass-spec

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

38 questions
asked by kofi_mensah 12k · 14 months ago
28 votes 5 answers32k views
Why does gradient slope change my apparent purity?

I have the report as a PDF with the chromatogram on page two, so I can quote specifics. I understand the observation; what I do not understand is the mechanism behind…

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 net_peptide 16k · 14 months ago
28 votes 5 answers28k views
Does aspartimide formation produce a resolvable peak on a C4 column, or does it co-elute?

Concretely: aspartimide formation · a C4 column. I want to know whether this is a real physical effect or an artefact of how it is measured. What prompted 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
peptide-stability
peptide-stability

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

832 questions
asked by ivo_paunovic 15k · 11 months ago
28 votes5 answers28k views
What does 96.8% purity on a C8 column actually tell me about an oral semaglutide vial?

Numbers first: 96.8% · a C8 column · oral semaglutide. 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 deamidation_watch 43k · 2.0 years ago