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purity

Page 14 of 33 · 788 questions tagged purity.

788 questions · sorted by votes · page 14 of 33

22 votes 5 answers9.3k views
Is 98.2% a realistic purity ceiling for liraglutide given its chain length?

The case in front of me: 98.2% · 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…

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 deamidation_watch 43k · 2 months ago
22 votes 3 answers8.9k views
Why does the same chromatogram give a different purity at 214 nm and at 280 nm?

A report I have includes traces at two wavelengths from the same injection, using a diode-array detector. The 214 nm trace integrates to 98.6% and the 280 nm trace to…

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
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…

360 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…

162 questions
asked by anja_hellstrom 13k · 2.1 years ago
22 votes 5 answers8.3k views
Does aggregation of mazdutide at 30 °C show up as a loss of content or of purity?

Setup, so nobody has to ask: aggregation · mazdutide · 30 °C. The empirical answer seems settled. The explanation does not. If the honest answer is that nobody knows,…

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 anja_hellstrom 13k · 6 months ago
22 votes2 answers7.3k views
What does a Karl Fischer water content test add for liraglutide that a purity figure does not?

Concretely: a Karl Fischer water content test · liraglutide. These are treated as interchangeable and I do not think they are. If both are acceptable I would like to…

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 Dr_Bram_Verhoeven 85k · 6 months ago
22 votes0 answers7.3k views
What counter-ion should I expect on a GGPeps semaglutide lot?

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

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 Dr_Elias_Weiss 46k · 7 months ago
22 votes2 answers6.3k views
Is a 98.8% result from Medutest comparable to 98.4% from Janoshik?

Setup, so nobody has to ask: 98.8% · Medutest · 98.4% · Janoshik. I suspect the honest answer is that it depends, in which case I would like to know on what. Assume 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
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 pk_curve 12k · 7 months ago
22 votes 4 answers5.6k views
Why would PeptideMeter report 97.1% where the supplier certificate says something higher?

Conditions: PeptideMeter · 97.1%. 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…

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 zainab_mustafa 16k · 4 months ago
22 votes 5 answers5.4k views
Does hydrolysis of dulaglutide at 37 °C show up as a loss of content or of purity?

Numbers first: hydrolysis · dulaglutide · 37 °C. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware this may have a boring answer.…

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 pascal_thibault 13k · 4 months ago
22 votes 5 answers5.2k views
What counter-ion should I expect on a JEEP dulaglutide lot?

Details up front: JEEP · dulaglutide. 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 grainne_ahearn 13k · 2 months ago
22 votes 4 answers4.9k views
How do I reconcile 97.9% from Medutest with 95.2% from the supplier?

Stated plainly: 97.9% · Medutest · 95.2%. 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 s_bhattacharya 42k · 4 months ago
22 votes 5 answers4.5k views
What does a 1 Da mass shift on an ESI-MS spectrum indicate?

The method section is present, which is unusual enough that I want to make use of it. I have read the primary source rather than the summary, which has left me with…

mass-spec
mass-spec

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

38 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-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 ivo_paunovic 15k · 2 months ago
22 votes4 answers4.3k views
What does 96.4% purity on a C8 column actually tell me about a tirzepatide vial?

What I have: 96.4% · 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 to…

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 fiadh_cronin 14k · 3 months ago
22 votes0 answers3.6k views
Would you accept 98.8% on liraglutide from BCH without a content assay?

Conditions: 98.8% · liraglutide · 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 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 coring_risk 17k · 5 months ago
21 votes 5 answers30k views
Is 97.1% a realistic purity ceiling for ecnoglutide given its chain length?

For reference: 97.1% · ecnoglutide. I would rather understand the derivation than memorise the outcome. Two people I asked gave two answers that differ by a factor of…

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 fib4_reader 35k · 19 months ago
21 votes 3 answers29k views
What counter-ion should I expect on an MKM survodutide lot?

The specifics, since they change the answer: MKM · survodutide. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. 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…

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 ayo_fadipe 19k · 19 months ago
21 votes5 answers24k views
Is a 97.9% result from Medutest comparable to 96.4% from PeptideMeter?

Stated plainly: 97.9% · Medutest · 96.4% · PeptideMeter. I suspect the honest answer is that it depends, in which case I would like to know on what. Assume I can…

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 petra_hovland 42k · 11 months ago
21 votes 5 answers23k views
How do I reconcile 97.6% from PeptideMeter with 97.1% from the supplier?

The specifics, since they change the answer: 97.6% · PeptideMeter · 97.1%. An unexpected observation, and I would like a differential rather than reassurance. 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 rae_oyelowo 21k · 12 months ago
21 votes 4 answers19k views
How does reference-standard error propagate into a retatrutide content figure?

The method section is present, which is unusual enough that I want to make use of it. 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 Dr_Wren_Halliday 40k · 11 months ago
21 votes 5 answers19k views
What does peptide mapping add for survodutide that a purity figure does not?

For reference: peptide mapping · survodutide. 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 ekaterina_volk 16k · 7 months ago
21 votes 4 answers18k views
Would you accept 98.2% on ecnoglutide from SWB without a content assay?

The particulars: 98.2% · ecnoglutide · SWB. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with explicit stopping…

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 fibre_or_fragment 12k · 2.3 years ago
21 votes5 answers18k views
What does a 97.6% purity with a lot-specific certificate attached let me conclude?

Numbers first: 97.6% · lot-specific certificate. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear to…

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 Dr_Idris_Coulibaly 40k · 2.3 years ago
21 votes5 answers17k views
Does an in-house standard invalidate a content result?

I have both a purity figure and a content figure, which is why the discrepancy is visible. I suspect the usual explanation for this is wrong, or at least incomplete.…

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 shear_at_the_front 15k · 21 months ago
21 votes5 answers17k views
Why is a residual-solvent figure almost never on a research certificate?

I have the report as a PDF with the chromatogram on page two, so I can quote specifics. I would like the mechanism, because I want to be able to reason about the…

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
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
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 fill_volume 13k · 2.2 years ago
21 votes5 answers17k views
Does dimerisation of a GLP-1 receptor agonist at minus 80 °C show up as a loss of content or of purity?

Stated plainly: dimerisation · a GLP-1 receptor agonist · minus 80 °C. I keep seeing this stated as a fact with no explanation attached, and unexplained facts make me…

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 gradient_slope 41k · 8 months ago