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purity

Page 16 of 35 · 833 questions tagged purity.

833 questions · sorted by votes · page 16 of 35

21 votes5 answers12k views
How does reference-standard error propagate into a dulaglutide content figure?

I am comparing a supplier certificate against an independent result on the same lot. I have worked this out and I would like someone to find the error, because I…

reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

185 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…

476 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…

833 questions
dulaglutide
dulaglutide

A once-weekly GLP-1 receptor agonist built on an Fc fusion rather than fatty-acid acylation. Use this tag for questions about the fusion-protein…

200 questions
asked by noor_alhassan 11k · 3 months ago
21 votes 5 answers11k views
How does reference-standard error propagate into a GLP-1 receptor agonist content figure?

I have the report as a PDF with the chromatogram on page two, so I can quote specifics. I can do the algebra. I am not confident about the conversion factors. If…

reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

185 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…

476 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…

833 questions
asked by ravi_pillai 12k · 10 months ago
21 votes0 answers9.7k views
Would you accept 98.2% on liraglutide from ERP without a content assay?

The case in front of me: 98.2% · liraglutide · ERP. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will follow the plan…

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…

833 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
liraglutide
liraglutide

A once-daily GLP-1 receptor agonist and the compound that established the class. Still relevant for its shorter half-life, its paediatric and…

235 questions
asked by shear_at_the_front 17k · 10 months ago
21 votes 5 answers9.3k views
How do I compute the +5 charge state m/z for a peptide of 4207.2 Da?

Conditions: +5 · 4207.2 Da. 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 value…

mass-spec
mass-spec

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

52 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…

764 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…

833 questions
asked by petra_hovland 35k · 6 months ago
21 votes0 answers9.3k views
How do I read a cagrilintide chromatogram from Janoshik beyond the headline number?

Setup, so nobody has to ask: cagrilintide · Janoshik. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not looked at anyone…

hplc
hplc

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

503 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…

833 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…

771 questions
amylin
amylin

Amylin and its analogues, most prominently cagrilintide, as a satiety mechanism orthogonal to incretin signalling. Includes the pharmacology of…

237 questions
janoshik
janoshik

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

139 questions
asked by zeynep_arslan 16k · 2.2 years ago
21 votes 5 answers9k views
How does oral semaglutide behave on a wide-pore C18 column compared to mazdutide?

The particulars: oral semaglutide · a wide-pore C18 column · mazdutide. I am trying to choose between two options that are usually discussed as though only one…

hplc
hplc

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

503 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…

833 questions
reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

185 questions
oral-glp1
oral-glp1

Oral routes for GLP-1 receptor agonism: peptide formulations rescued by absorption enhancers such as SNAC, and true small molecules that need no…

219 questions
mazdutide
mazdutide

A GLP-1 and glucagon receptor dual agonist developed primarily in China, with a distinct dose range and a fast-moving publication record.…

237 questions
asked by klara_novotna 19k · 10 months ago
21 votes5 answers8.8k views
Does racemisation produce a resolvable peak on a C8 column, or does it co-elute?

Details up front: racemisation · a C8 column. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware this may have a boring answer. I…

hplc
hplc

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

503 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…

833 questions
peptide-stability
peptide-stability

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

908 questions
asked by Dr_Malik_Osei 19k · 5 months ago
21 votes0 answers7.1k views
Would you accept 98.2% on mazdutide from QST without a content assay?

Stated plainly: 98.2% · mazdutide · QST. I am trying to build something sustainable rather than something thorough that I will abandon. I have already decided 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…

833 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…

476 questions
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

454 questions
mazdutide
mazdutide

A GLP-1 and glucagon receptor dual agonist developed primarily in China, with a distinct dose range and a fast-moving publication record.…

237 questions
asked by Dr_Jonas_Halvorsen 28k · 10 months ago
21 votes 1 answer7k views
What counter-ion should I expect on an MKM ecnoglutide lot?

The particulars: MKM · ecnoglutide. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I am reasonably comfortable…

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…

88 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…

833 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…

476 questions
ecnoglutide
ecnoglutide

A long-acting GLP-1 receptor agonist with a cAMP-biased signalling profile. A niche tag, mostly used for mechanism questions about biased agonism…

223 questions
asked by drawn_and_capped 12k · 6 months ago
21 votes 4 answers6.9k views
What makes something a "certified reference material", and why is my content result only as good as the standard?

Every explanation of quantitative HPLC I have read says the result is traceable to the reference standard, and then moves on as though that settles it. I want to open…

reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

185 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…

476 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…

771 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…

910 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…

833 questions
asked by lukas_sedlacek 16k · 16 months ago
21 votes 3 answers5.2k views
Can peptide mapping detect a D-amino acid or a scrambled sequence that co-elutes with the main peak?

The recurring point in this tag is that stereoisomers and sequence isomers are invisible to mass spectrometry. I accept that for intact mass. What I want to know is…

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…

103 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…

833 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…

10 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…

771 questions
reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

185 questions
asked by Dr_Jonas_Halvorsen 28k · 6 months ago
21 votes5 answers3.5k views
Is 95.2% a realistic purity ceiling for ecnoglutide given its chain length?

The specifics, since they change the answer: 95.2% · ecnoglutide. I would like the arithmetic checked rather than the conclusion asserted. I have deliberately 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…

833 questions
hplc
hplc

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

503 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…

103 questions
ecnoglutide
ecnoglutide

A long-acting GLP-1 receptor agonist with a cAMP-biased signalling profile. A niche tag, mostly used for mechanism questions about biased agonism…

223 questions
asked by ivo_paunovic 16k · 25 days ago
20 votes5 answers39k views
Is a 96.8% result from VendorInvestigate comparable to 99.4% from Medutest?

Conditions: 96.8% · VendorInvestigate · 99.4% · Medutest. I would like the axes of comparison first and the recommendation second. I have tried the first option and…

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…

833 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…

910 questions
reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

185 questions
vendor-investigate
vendor-investigate

VendorInvestigate, an independent vendor review and verification service. Use this tag for questions about its verification criteria, what a…

113 questions
medutest
medutest

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

126 questions
asked by thabo_maseko 28k · 2.2 years ago
20 votes5 answers38k views
How do I reconcile 98.2% from Medutest with 99.1% from the supplier?

Setup, so nobody has to ask: 98.2% · Medutest · 99.1%. This is not behaving the way I expected and I want to understand the discrepancy before I act on it. I have…

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…

833 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…

910 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…

771 questions
medutest
medutest

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

126 questions
asked by cal_hennessy 17k · 2.2 years ago
20 votes 5 answers30k views
What does 99.4% purity on a C4 column actually tell me about an orforglipron vial?

Conditions: 99.4% · a C4 column · orforglipron. 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,…

503 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…

833 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…

771 questions
orforglipron
orforglipron

A non-peptide, orally bioavailable small-molecule GLP-1 receptor agonist studied in the ATTAIN programme. It is not a peptide, which changes…

219 questions
asked by harriet_lonsdale 35k · 19 months ago
20 votes 5 answers26k views
What is aspartimide formation and how would I detect it?

I have continuous temperature data for the period in question, which is unusual and I would like to use it. I would like the mechanism, because I want to be able to…

peptide-stability
peptide-stability

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

908 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…

833 questions
mass-spec
mass-spec

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

52 questions
asked by kirsi_lahtinen 25k · 14 months ago
20 votes 5 answers24k views
What does a 95.2% purity with a batch certificate attached let me conclude?

What I am working with: 95.2% · batch certificate. I have read the primary source rather than the summary, which has left me with more questions. I understand 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…

833 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…

771 questions
hplc
hplc

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

503 questions
asked by leonid_marchuk 19k · 20 months ago
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,…

908 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…

476 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…

833 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…

370 questions
asked by anders_vestby 8.5k · 16 months ago
20 votes0 answers23k views
Why would Janoshik report 99.4% where the supplier certificate says something higher?

What I am working with: Janoshik · 99.4%. 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…

833 questions
hplc
hplc

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

503 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…

910 questions
janoshik
janoshik

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

139 questions
asked by esben_lykke 84k · 20 months ago
20 votes5 answers23k views
Does fibrillation of semaglutide at room temperature show up as a loss of content or of purity?

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

peptide-stability
peptide-stability

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

908 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…

476 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…

833 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…

470 questions
asked by hana_petrikova 10k · 11 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…

476 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…

833 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…

771 questions
asked by pieter_maas 14k · 2.2 years ago
20 votes 5 answers20k views
What counter-ion should I expect on a GL Biochem ecnoglutide lot?

The case in front of me: GL Biochem · ecnoglutide. I want to understand what this actually establishes, as opposed to what it is being used to imply. My concern is…

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…

88 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…

833 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…

476 questions
ecnoglutide
ecnoglutide

A long-acting GLP-1 receptor agonist with a cAMP-biased signalling profile. A niche tag, mostly used for mechanism questions about biased agonism…

223 questions
asked by cake_intact 17k · 14 months ago
20 votes 5 answers17k views
Is 97.6% a realistic purity ceiling for tirzepatide given its chain length?

Conditions: 97.6% · tirzepatide. 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…

833 questions
hplc
hplc

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

503 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…

103 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…

370 questions
asked by ravenna_pace 14k · 7 months ago
20 votes 5 answers17k views
What does a 99.4% purity with a date of analysis attached let me conclude?

Concretely: 99.4% · 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…

833 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…

771 questions
hplc
hplc

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

503 questions
asked by rhian_prydderch 23k · 15 months ago