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peptide-stability

The chemistry of peptide degradation: deamidation, oxidation, hydrolysis, aggregation and fibrillation, and how temperature, pH, ionic strength, agitation and surface contact each accelerate a different one of them.

832 questions · sorted by votes · page 1 of 35

41 votes5 answers71k views
My a GLP-1 receptor agonist vial sat at minus 80 °C for seven days — is testing worth it before use?

Details up front: a GLP-1 receptor agonist · minus 80 °C · seven days. This is a planning question. I know what my options are; I do not know how to weigh them. What…

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 ines_delacruz 16k · 23 months ago
41 votes2 answers57k views
What happens to mazdutide after sixteen weeks at minus 20 °C in solution?

Details up front: mazdutide · sixteen weeks · minus 20 °C. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware this may have a…

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 cap_the_luer 15k · 2.1 years ago
41 votes0 answers48k views
Does racemisation of dulaglutide at 40 °C show up as a loss of content or of purity?

Numbers first: racemisation · dulaglutide · 40 °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…

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 cake_intact 18k · 21 months ago
41 votes 5 answers40k views
Is there any published stability data for mazdutide at room temperature?

What I have: mazdutide · room temperature. I am asking for verification rather than opinion, ideally with something I can read myself. It is possible the evidence…

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 rania_haddad 17k · 21 months ago
41 votes 4 answers39k views
Would you re-test a GLP-1 receptor agonist after sixteen weeks at 30 °C, or accept the original certificate?

What I have: a GLP-1 receptor agonist · sixteen weeks · 30 °C. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone…

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 Dr_Priya_Raghunathan 94k · 2.3 years ago
41 votes 5 answers37k views
My mazdutide vial sat at 25 °C for seven days — is testing worth it before use?

What I have: mazdutide · 25 °C · seven days. 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…

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 syringe_ninety 15k · 2.0 years ago
41 votes 5 answers37k views
How long does liraglutide stay within specification at 25 °C once reconstituted?

The specifics, since they change the answer: liraglutide · 25 °C. I want a method I can write down and repeat, not a rule of thumb. I would rather over-engineer 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 bridget_nyathi 16k · 23 months ago
41 votes5 answers36k views
Does deamidation dominate for survodutide held at 4 °C?

The particulars: deamidation · survodutide · 4 °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
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 anders_vestby 17k · 20 months ago
41 votes5 answers33k views
Does a GLP-1 receptor agonist adsorb measurably to the vial wall at 4 mg/mL?

Details up front: a GLP-1 receptor agonist · 4 mg/mL. I can do the algebra. I am not confident about the conversion factors. If there is a standard way to lay this…

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
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 sinead_gaffney 14k · 2.0 years ago
41 votes 5 answers27k views
Does fibrillation dominate for survodutide held at minus 20 °C?

The specifics, since they change the answer: fibrillation · survodutide · minus 20 °C. I understand the observation; what I do not understand is the mechanism behind…

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 ellis_thorne 17k · 20 months ago
41 votes 5 answers21k views
Is cagrilintide at 10 mg/mL stable enough for eight weeks of multi-withdrawal use?

What I have: cagrilintide · 10 mg/mL · eight weeks. I would rather be corrected now than propagate something wrong. I am specifically not interested in a testimonial;…

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 Dr_Signe_Baldursdottir 46k · 2.0 years ago
41 votes0 answers18k views
Is there any published stability data for liraglutide at minus 20 °C?

The particulars: liraglutide · minus 20 °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 seamus_brady 17k · 21 months ago
40 votes 4 answers68k views
Does survodutide adsorb measurably to the vial wall at 20 mg/mL?

The case in front of me: survodutide · 20 mg/mL. I want the working, not the result — I need to be able to redo it with different numbers. I care about the precision…

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
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 mg_per_ml 12k · 2.3 years ago
40 votes5 answers60k views
Why does aggregation accelerate at minus 20 °C rather than proceeding linearly?

Setup, so nobody has to ask: aggregation · minus 20 °C. I keep seeing this stated as a fact with no explanation attached, and unexplained facts make me suspicious. My…

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 sunniva_dahl 11k · 23 months ago
40 votes5 answers58k views
Is liraglutide at 2.5 mg/mL stable enough for twelve weeks of multi-withdrawal use?

For reference: liraglutide · 2.5 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 tess_amankwah 48k · 19 months ago
40 votes 3 answers57k views
Is there any published stability data for ecnoglutide at 2–8 °C?

The case in front of me: ecnoglutide · 2–8 °C. The claim is plausible, which is exactly why I want to check it. I am able to read a paper if someone points me at one.…

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 p_mkhize 41k · 2.0 years ago
40 votes 4 answers50k views
Is 37 °C an acceptable storage condition for lyophilised tirzepatide?

Concretely: 37 °C · tirzepatide. The claim is plausible, which is exactly why I want to check it. I am able to read a paper if someone points me at one. Is there data…

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 oona_kekkonen 16k · 22 months ago
40 votes 5 answers42k views
Does aggregation of cagrilintide at room temperature show up as a loss of content or of purity?

Setup, so nobody has to ask: aggregation · cagrilintide · room temperature. The empirical answer seems settled. The explanation does not. If the honest answer is that…

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 grainne_ahearn 13k · 22 months ago
40 votes 5 answers41k views
How long does dulaglutide stay within specification at 4 °C once reconstituted?

What I am working with: dulaglutide · 4 °C. This is a procedural question rather than a theoretical one, and I would like the procedure rather than the theory. What 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
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 label_claim 11k · 2.3 years ago
40 votes0 answers32k views
Why does aggregation accelerate at minus 80 °C rather than proceeding linearly?

Setup, so nobody has to ask: aggregation · minus 80 °C. I keep seeing this stated as a fact with no explanation attached, and unexplained facts make me suspicious. My…

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 eoin_mcgarry 16k · 23 months ago
40 votes5 answers31k views
Does aggregation dominate for a GLP-1 receptor agonist held at 4 °C?

Setup, so nobody has to ask: aggregation · a GLP-1 receptor agonist · 4 °C. I keep seeing this stated as a fact with no explanation attached, and unexplained facts…

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 ruaidhri_o_shea 51k · 23 months ago
40 votes 5 answers23k views
Would you re-test retatrutide after two weeks at minus 20 °C, or accept the original certificate?

What I am working with: retatrutide · two weeks · minus 20 °C. I am trying to build something sustainable rather than something thorough that I will abandon. I have…

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 lukas_sedlacek 17k · 2.1 years ago
39 votes 5 answers71k views
Does fibrillation dominate for semaglutide held at 2–8 °C?

For reference: fibrillation · semaglutide · 2–8 °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
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 klara_novotna 16k · 2.2 years ago
39 votes 4 answers50k views
How many freeze-thaw cycles will a GLP-1 receptor agonist at 2.5 mg/mL tolerate?

Numbers first: a GLP-1 receptor agonist · 2.5 mg/mL. I can find plenty of assertions about this and almost no reasoning, which is usually a sign that nobody has…

freeze-thaw
freeze-thaw

What repeated freezing does to a peptide in solution: ice-crystal shear at the growing front, freeze-concentration of solutes, pH shifts as buffer…

55 questions
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
asked by klara_novotna 16k · 2.4 years ago
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