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peptide-stability

Page 30 of 35 · 832 questions tagged peptide-stability.

832 questions · sorted by votes · page 30 of 35

7 votes5 answers13k views
Does aspartimide formation dominate for tirzepatide held at room temperature?

Conditions: aspartimide formation · tirzepatide · room temperature. I want to know whether this is a real physical effect or an artefact of how it is measured. What…

peptide-stability
peptide-stability

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

832 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
hplc
hplc

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

466 questions
asked by k_szabo 45k · 13 months ago
7 votes 5 answers12k views
Is oral semaglutide at 4 mg/mL stable enough for twelve weeks of multi-withdrawal use?

For reference: oral semaglutide · 4 mg/mL · twelve weeks. I would like to know whether this claim survives contact with evidence. If the answer is "nobody has tested…

peptide-stability
peptide-stability

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

832 questions
bacteriostatic-water
bacteriostatic-water

Water for injection containing roughly 0.9 per cent benzyl alcohol as a bacteriostatic agent. It suppresses growth in a multiple-withdrawal vial;…

112 questions
shelf-life
shelf-life

How long a preparation remains within specification: labelled expiry for a sealed lyophilised vial, beyond-use dating after reconstitution, and…

301 questions
asked by swab_stopper 16k · 10 months ago
7 votes5 answers12k views
My survodutide vial sat at 40 °C for five days — is testing worth it before use?

Conditions: survodutide · 40 °C · five days. 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…

cold-chain
cold-chain

Keeping material within a temperature window from manufacture to use: phase-change packs versus dry ice, thermal mass, transit-lane temperature…

524 questions
peptide-stability
peptide-stability

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

832 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 coring_risk 17k · 14 months ago
7 votes 5 answers11k views
Does aspartimide formation of liraglutide at room temperature show up as a loss of content or of purity?

Conditions: aspartimide formation · liraglutide · room temperature. This is one of those things that everyone repeats and nobody derives. This matters practically,…

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 otto_brenner 19k · 7 months ago
7 votes 5 answers8.4k views
Why does deamidation accelerate at 37 °C rather than proceeding linearly?

The specifics, since they change the answer: deamidation · 37 °C. 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
storage
storage

Storage conditions and their evidence base: minus twenty degrees for powder, refrigerated for solution, protection from light, and what the…

646 questions
hplc
hplc

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

466 questions
asked by nominal_ten 14k · 3 months ago
7 votes5 answers6.7k views
How long does oral semaglutide stay within specification at 25 °C once reconstituted?

For reference: oral semaglutide · 25 °C. I want a method I can write down and repeat, not a rule of thumb. I would rather over-engineer this than discover a problem…

peptide-stability
peptide-stability

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

832 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
shelf-life
shelf-life

How long a preparation remains within specification: labelled expiry for a sealed lyophilised vial, beyond-use dating after reconstitution, and…

301 questions
asked by pascal_thibault 13k · 9 months ago
7 votes5 answers6.4k views
How long does oral semaglutide stay within specification at 37 °C once reconstituted?

For reference: oral semaglutide · 37 °C. I have read the obvious sources and they disagree with each other, so I would rather ask people who have actually done this.…

peptide-stability
peptide-stability

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

832 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
shelf-life
shelf-life

How long a preparation remains within specification: labelled expiry for a sealed lyophilised vial, beyond-use dating after reconstitution, and…

301 questions
asked by teodora_ilic 15k · 3 months ago
7 votes0 answers6.2k views
Does dimerisation dominate for cagrilintide held at minus 20 °C?

Stated plainly: dimerisation · cagrilintide · minus 20 °C. The empirical answer seems settled. The explanation does not. If the honest answer is that nobody knows, I…

peptide-stability
peptide-stability

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

832 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
hplc
hplc

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

466 questions
asked by k_szabo 45k · 14 months ago
7 votes2 answers5.6k views
Would you re-test ecnoglutide after twelve weeks at room temperature, or accept the original certificate?

Conditions: ecnoglutide · twelve weeks · room temperature. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will follow…

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
peptide-stability
peptide-stability

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

832 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 per_haugen 18k · 6 months ago
7 votes 5 answers5.4k views
Does reconstituting survodutide with sterile water for injection change anything I should know about?

The case in front of me: survodutide · sterile water for injection. I want to know whether this is a real physical effect or an artefact of how it is measured. What…

reconstitution
reconstitution

Taking a lyophilised vial to a solution of known concentration: choice of diluent, volume selection, how to add liquid without shearing the cake,…

330 questions
bacteriostatic-water
bacteriostatic-water

Water for injection containing roughly 0.9 per cent benzyl alcohol as a bacteriostatic agent. It suppresses growth in a multiple-withdrawal vial;…

112 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 bea_forsberg 14k · 8 months ago
7 votes 5 answers5.1k views
Is tirzepatide at 2.5 mg/mL stable enough for twelve weeks of multi-withdrawal use?

The specifics, since they change the answer: tirzepatide · 2.5 mg/mL · twelve weeks. I would like to know whether this claim survives contact with evidence. If the…

peptide-stability
peptide-stability

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

832 questions
bacteriostatic-water
bacteriostatic-water

Water for injection containing roughly 0.9 per cent benzyl alcohol as a bacteriostatic agent. It suppresses growth in a multiple-withdrawal vial;…

112 questions
shelf-life
shelf-life

How long a preparation remains within specification: labelled expiry for a sealed lyophilised vial, beyond-use dating after reconstitution, and…

301 questions
asked by mass_shift_18 14k · 11 months ago
7 votes 5 answers4.8k views
What happens to dulaglutide after two weeks at minus 20 °C in solution?

What I am working with: dulaglutide · two weeks · minus 20 °C. The empirical answer seems settled. The explanation does not. If the honest answer is that nobody…

peptide-stability
peptide-stability

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

832 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
shelf-life
shelf-life

How long a preparation remains within specification: labelled expiry for a sealed lyophilised vial, beyond-use dating after reconstitution, and…

301 questions
asked by Dr_Tomas_Kral 37k · 7 months ago
7 votes0 answers3.9k views
Why does racemisation accelerate at 2–8 °C rather than proceeding linearly?

Details up front: racemisation · 2–8 °C. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware this may have a boring answer. 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
storage
storage

Storage conditions and their evidence base: minus twenty degrees for powder, refrigerated for solution, protection from light, and what the…

646 questions
hplc
hplc

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

466 questions
asked by assay_blank 39k · 9 months ago
7 votes 3 answers3.7k views
Does oxidation dominate for liraglutide held at 40 °C?

The case in front of me: oxidation · liraglutide · 40 °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
storage
storage

Storage conditions and their evidence base: minus twenty degrees for powder, refrigerated for solution, protection from light, and what the…

646 questions
hplc
hplc

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

466 questions
asked by shear_at_the_front 15k · 40 days ago
7 votes2 answers2.1k views
Is there any published stability data for oral semaglutide at 37 °C?

For reference: oral semaglutide · 37 °C. I would like to know whether this claim survives contact with evidence. If the answer is "nobody has tested that", 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
storage
storage

Storage conditions and their evidence base: minus twenty degrees for powder, refrigerated for solution, protection from light, and what the…

646 questions
clinical-trials
clinical-trials

Reading the primary literature properly: estimands, intention-to-treat versus per-protocol, confidence intervals, absolute versus relative…

913 questions
asked by stopper_core 50k · 17 days ago
7 votes 3 answers1.6k views
Why does hydrolysis accelerate at 2–8 °C rather than proceeding linearly?

Numbers first: hydrolysis · 2–8 °C. I can predict the outcome but I cannot explain it, which means I will get the next case wrong. I would like to know how confident…

peptide-stability
peptide-stability

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

832 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
hplc
hplc

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

466 questions
asked by lyoph_cake 95k · 19 days ago
7 votes0 answers1.6k views
Is a re-test after storage a stability study or a waste of money?

The material is still sealed, so I have not committed to anything yet. This is a planning question. I know what my options are; I do not know how to weigh them. What…

peptide-stability
peptide-stability

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

832 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
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 Dr_Lena_Ostrowska 42k · 4 months ago
6 votes5 answers24k views
Why does hydrolysis accelerate at 4 °C rather than proceeding linearly?

Details up front: hydrolysis · 4 °C. I can predict the outcome but I cannot explain it, which means I will get the next case wrong. I would like to know how confident…

peptide-stability
peptide-stability

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

832 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
hplc
hplc

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

466 questions
asked by lucia_marchetti 18k · 2.1 years ago
6 votes 5 answers22k views
My oral semaglutide vial sat at 40 °C for fourteen days — is testing worth it before use?

For reference: oral semaglutide · 40 °C · fourteen days. I am at the decision point and I would rather think it through than improvise. I would rather spend money on…

cold-chain
cold-chain

Keeping material within a temperature window from manufacture to use: phase-change packs versus dry ice, thermal mass, transit-lane temperature…

524 questions
peptide-stability
peptide-stability

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

832 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 tenth_of_a_unit 40k · 19 months ago
6 votes 5 answers22k views
Is minus 80 °C an acceptable storage condition for lyophilised dulaglutide?

What I have: minus 80 °C · dulaglutide. I am asking for verification rather than opinion, ideally with something I can read myself. It is possible the evidence exists…

storage
storage

Storage conditions and their evidence base: minus twenty degrees for powder, refrigerated for solution, protection from light, and what the…

646 questions
peptide-stability
peptide-stability

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

832 questions
shelf-life
shelf-life

How long a preparation remains within specification: labelled expiry for a sealed lyophilised vial, beyond-use dating after reconstitution, and…

301 questions
asked by nadia_kowalczyk 14k · 2.3 years ago
6 votes 5 answers21k views
Would you re-test liraglutide after ten weeks at 30 °C, or accept the original certificate?

The particulars: liraglutide · ten weeks · 30 °C. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with explicit…

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
peptide-stability
peptide-stability

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

832 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 tobias_reint 19k · 16 months ago
6 votes 5 answers20k views
Does fibrillation of survodutide at 25 °C show up as a loss of content or of purity?

For reference: fibrillation · survodutide · 25 °C. I would like the mechanism, because I want to be able to reason about the cases nobody has written about. I have…

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 zainab_mustafa 16k · 18 months ago
6 votes5 answers16k views
How long does mazdutide stay within specification at 37 °C once reconstituted?

Numbers first: mazdutide · 37 °C. I can find plenty of assertions about this and almost no reasoning, which is usually a sign that nobody has checked. Assume no…

peptide-stability
peptide-stability

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

832 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
shelf-life
shelf-life

How long a preparation remains within specification: labelled expiry for a sealed lyophilised vial, beyond-use dating after reconstitution, and…

301 questions
asked by lyoph_cake 95k · 2.0 years ago
6 votes 5 answers14k views
Is room temperature an acceptable storage condition for lyophilised survodutide?

For reference: room temperature · survodutide. Somebody stated this to me confidently and I would like to check it before repeating it. I would accept a well-reasoned…

storage
storage

Storage conditions and their evidence base: minus twenty degrees for powder, refrigerated for solution, protection from light, and what the…

646 questions
peptide-stability
peptide-stability

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

832 questions
shelf-life
shelf-life

How long a preparation remains within specification: labelled expiry for a sealed lyophilised vial, beyond-use dating after reconstitution, and…

301 questions
asked by RP_C18 85k · 16 months ago