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peptide-stability

Page 13 of 35 · 832 questions tagged peptide-stability.

832 questions · sorted by votes · page 13 of 35

23 votes 3 answers25k views
Is tirzepatide at 2.5 mg/mL stable enough for four weeks of multi-withdrawal use?

For reference: tirzepatide · 2.5 mg/mL · four weeks. Somebody stated this to me confidently and I would like to check it before repeating it. I would accept a…

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 · 15 months ago
23 votes 5 answers24k views
How long does semaglutide stay within specification at 40 °C once reconstituted?

The case in front of me: semaglutide · 40 °C. I have done this once and I suspect I got away with it rather than got it right. For context: I keep records of every…

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 rukhsana_iqbal 14k · 11 months ago
23 votes 5 answers21k views
My ecnoglutide vial sat at 30 °C for five days — is testing worth it before use?

Conditions: ecnoglutide · 30 °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 carys_meredith 17k · 13 months ago
23 votes 5 answers17k views
What happens to cagrilintide after six weeks at 4 °C in solution?

Numbers first: cagrilintide · six weeks · 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…

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 forty_units 14k · 7 months ago
23 votes 5 answers15k views
Does cagrilintide adsorb measurably to the vial wall at 2.5 mg/mL?

Numbers first: cagrilintide · 2.5 mg/mL. This should be a straightforward calculation and I keep getting two different answers. The numbers are arbitrary; the method…

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 deamidation_watch 43k · 10 months ago
23 votes 5 answers15k views
My ecnoglutide vial sat at 4 °C for five days — is testing worth it before use?

The case in front of me: ecnoglutide · 4 °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…

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 Dr_Lena_Ostrowska 42k · 21 months ago
23 votes5 answers15k views
Does racemisation dominate for retatrutide held at 2–8 °C?

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

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 fresh_bac 13k · 14 months ago
23 votes5 answers14k views
Does deamidation of survodutide at 25 °C show up as a loss of content or of purity?

For reference: deamidation · survodutide · 25 °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
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 samir_bennani 13k · 15 months ago
23 votes 3 answers14k views
Does hydrolysis of dulaglutide at 4 °C show up as a loss of content or of purity?

Details up front: hydrolysis · dulaglutide · 4 °C. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware this may have a boring…

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 halvard_ness 42k · 6 months ago
23 votes5 answers13k views
How long does orforglipron stay within specification at 37 °C once reconstituted?

Setup, so nobody has to ask: orforglipron · 37 °C. This is a procedural question rather than a theoretical one, and I would like the procedure rather than the theory.…

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 thermal_mass 16k · 20 months ago
23 votes 5 answers12k views
What happens to semaglutide after twelve weeks at minus 20 °C in solution?

Conditions: semaglutide · twelve weeks · minus 20 °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
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 forty_units 14k · 13 months ago
23 votes 5 answers12k views
Does racemisation of orforglipron at 37 °C show up as a loss of content or of purity?

What I have: racemisation · orforglipron · 37 °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 coldbox9 13k · 3 months ago
23 votes2 answers11k views
Is ecnoglutide at 8 mg/mL stable enough for ten weeks of multi-withdrawal use?

Conditions: ecnoglutide · 8 mg/mL · ten weeks. 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
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 dead_volume 49k · 11 months ago
23 votes0 answers8.3k views
Would you re-test mazdutide after sixteen weeks at room temperature, or accept the original certificate?

What I have: mazdutide · sixteen weeks · room temperature. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone can…

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 dana_wexler 15k · 4 months ago
23 votes 5 answers8.3k views
My dulaglutide vial sat at 30 °C for forty-two days — is testing worth it before use?

Stated plainly: dulaglutide · 30 °C · forty-two days. I am trying to build something sustainable rather than something thorough that I will abandon. I have already…

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 marcus_thorbjorn 16k · 11 months ago
23 votes5 answers6.3k views
Would you re-test dulaglutide after two weeks at room temperature, or accept the original certificate?

What I am working with: dulaglutide · two weeks · room temperature. I am trying to build something sustainable rather than something thorough that I will abandon. I…

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 thabo_maseko 20k · 7 months ago
23 votes0 answers6k views
What happens to oral semaglutide after ten weeks at 2–8 °C in solution?

For reference: oral semaglutide · ten weeks · 2–8 °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
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 halvard_ness 42k · 3 months ago
23 votes0 answers4.5k views
My retatrutide vial sat at 37 °C for forty-two days — is testing worth it before use?

Stated plainly: retatrutide · 37 °C · forty-two days. I am trying to build something sustainable rather than something thorough that I will abandon. I have already…

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 mz_4113 99k · 6 months ago
22 votes 5 answers38k views
How many freeze-thaw cycles will semaglutide at 5 mg/mL tolerate?

The case in front of me: semaglutide · 5 mg/mL. I have done this once and I suspect I got away with it rather than got it right. For context: I keep records of every…

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 rae_oyelowo 21k · 19 months ago
22 votes 2 answers30k views
How long does tirzepatide stay within specification at 2–8 °C once reconstituted?

For reference: tirzepatide · 2–8 °C. I have read the obvious sources and they disagree with each other, so I would rather ask people who have actually done this. 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 ines_delacruz 16k · 17 months ago
22 votes4 answers25k views
Does lyophilised powder actually need −20 °C, or is 4 °C fine? What is the real mechanism?

Every supplier sheet I have says "store lyophilised powder at −20 °C for long-term, 2–8 °C for short-term, room temperature acceptable for shipping". Nobody explains…

lyophilisation
lyophilisation

Freeze-drying: primary and secondary drying, collapse temperature, the role of bulking agents and cryoprotectants such as mannitol and trehalose,…

17 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
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 birk_nordahl 20k · 23 months ago
22 votes 5 answers20k views
Does aggregation dominate for a GLP-1 receptor agonist held at minus 80 °C?

Stated plainly: aggregation · 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
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 cake_collapsed 13k · 10 months ago
22 votes 5 answers19k views
Why does oxidation accelerate at minus 20 °C rather than proceeding linearly?

Conditions: oxidation · minus 20 °C. This is one of those things that everyone repeats and nobody derives. This matters practically, not just academically, because it…

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 Dr_Lena_Ostrowska 42k · 13 months ago
22 votes 5 answers18k views
Is there any reason to warm a vial to speed dissolution?

My setup is a refrigerator with a logger and a small work area I wipe down, nothing more. The empirical answer seems settled. The explanation does not. If the honest…

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
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 swab_and_wait 15k · 12 months ago