PeptideStack
5.2kquestions
20kanswers
220users

peptide-stability

Page 8 of 35 · 832 questions tagged peptide-stability.

832 questions · sorted by votes · page 8 of 35

28 votes5 answers48k views
Would you re-test cagrilintide after sixteen weeks at minus 20 °C, or accept the original certificate?

Numbers first: cagrilintide · sixteen weeks · minus 20 °C. 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 marta_szymanska 17k · 2.3 years ago
28 votes 5 answers38k views
Is there any published stability data for a GLP-1 receptor agonist at minus 20 °C?

What I have: a GLP-1 receptor agonist · minus 20 °C. I am asking for verification rather than opinion, ideally with something I can read myself. It is possible the…

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 assay_blank 39k · 2.3 years ago
28 votes 4 answers34k views
Is cagrilintide at 6.67 mg/mL stable enough for two weeks of multi-withdrawal use?

Details up front: cagrilintide · 6.67 mg/mL · two weeks. I am asking for verification rather than opinion, ideally with something I can read myself. It is possible…

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 teodora_ilic 15k · 22 months ago
28 votes 5 answers34k views
How long does cagrilintide stay within specification at minus 20 °C once reconstituted?

What I have: cagrilintide · minus 20 °C. I would like to understand the steps well enough to explain them to someone else. I have access to a refrigerator with 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 w_okoye 40k · 2.2 years ago
28 votes 3 answers30k views
How do I read a lyophilised cake? Intact puck versus collapsed versus meltback versus a thin film

I have accumulated enough vials from enough sources that the cakes now look wildly different from each other, and I have no framework for interpreting that. Examples…

vial-inspection
vial-inspection

What you can learn by looking: cake morphology, meniscus films, fibres versus stopper fragments versus true particulates, clarity after…

66 questions
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
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 · 2.0 years ago
28 votes 5 answers30k views
How long can a reconstituted vial sit at room temperature before I should bin it?

The material is still sealed, so I have not committed to anything yet. I want a method I can write down and repeat, not a rule of thumb. I would rather over-engineer…

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
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
asked by mass_shift_18 14k · 20 months ago
28 votes 5 answers28k views
Does aspartimide formation produce a resolvable peak on a C4 column, or does it co-elute?

Concretely: aspartimide formation · a C4 column. I want to know whether this is a real physical effect or an artefact of how it is measured. What prompted the…

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
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 ivo_paunovic 15k · 11 months ago
28 votes5 answers28k views
Why does deamidation accelerate at 4 °C rather than proceeding linearly?

The specifics, since they change the answer: deamidation · 4 °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 w_okoye 40k · 16 months ago
28 votes5 answers20k views
My liraglutide vial sat at 4 °C for three days — is testing worth it before use?

The particulars: liraglutide · 4 °C · three days. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with explicit…

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_Fatima_Belkacem 52k · 11 months ago
28 votes5 answers18k views
Is 4 °C an acceptable storage condition for lyophilised ecnoglutide?

For reference: 4 °C · ecnoglutide. I would like to know whether this claim survives contact with evidence. If the answer is "nobody has tested that", I would like…

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 birk_nordahl 20k · 15 months ago
28 votes 5 answers17k views
Would you re-test a GLP-1 receptor agonist after six weeks at 30 °C, or accept the original certificate?

What I have: a GLP-1 receptor agonist · six weeks · 30 °C. This is a planning question. I know what my options are; I do not know how to weigh them. What I want is…

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 cap_the_luer 15k · 2.0 years ago
28 votes5 answers16k views
Is there any published stability data for a GLP-1 receptor agonist at 40 °C?

Details up front: a GLP-1 receptor agonist · 40 °C. I am asking for verification rather than opinion, ideally with something I can read myself. It is possible the…

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 nkem_obiora 46k · 7 months ago
28 votes0 answers14k views
Is siliconisation of the stopper something I can detect?

I keep a written log of every draw with date, volume and syringe type. I can parse the result. I am less sure what it licenses me to conclude. I have deliberately not…

vial-inspection
vial-inspection

What you can learn by looking: cake morphology, meniscus films, fibres versus stopper fragments versus true particulates, clarity after…

66 questions
lyophilisation
lyophilisation

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

17 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 Dr_Aoife_Brennan 50k · 19 months ago
28 votes 5 answers13k views
Does reconstituting tirzepatide with bacteriostatic water change anything I should know about?

The particulars: tirzepatide · bacteriostatic water. I would like the mechanism, because I want to be able to reason about the cases nobody has written about. I have…

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 jo_vandeberg 19k · 16 months ago
28 votes2 answers11k views
Is survodutide at 20 mg/mL stable enough for ten weeks of multi-withdrawal use?

Conditions: survodutide · 20 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…

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 ahmed_zerouali 19k · 8 months ago
28 votes 5 answers10k views
Would you re-test semaglutide after twelve weeks at room temperature, or accept the original certificate?

The case in front of me: semaglutide · twelve weeks · room temperature. I want to decide this in advance so that I am not deciding it under pressure later. Assume 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 jo_vandeberg 19k · 11 months ago
28 votes5 answers9.8k views
How many freeze-thaw cycles will mazdutide at 2.5 mg/mL tolerate?

Numbers first: mazdutide · 2.5 mg/mL. I would like to understand the steps well enough to explain them to someone else. I have access to a refrigerator with a logger…

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 cap_the_luer 15k · 12 months ago
27 votes5 answers41k views
Would you re-test ecnoglutide after four weeks at 30 °C, or accept the original certificate?

Concretely: ecnoglutide · four weeks · 30 °C. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in view and I would like…

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 · 2.0 years ago
27 votes 5 answers40k views
How long does retatrutide stay within specification at minus 80 °C once reconstituted?

What I am working with: retatrutide · minus 80 °C. Everything I have found on this is either a forum aside or a product page, neither of which I trust. I am…

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 tabular_nums 47k · 21 months ago
27 votes5 answers38k views
My dulaglutide vial sat at room temperature for ten days — is testing worth it before use?

What I am working with: dulaglutide · room temperature · ten days. I would like to set this up properly once, rather than adjust it repeatedly. My budget is real but…

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 cal_hennessy 14k · 20 months ago
27 votes0 answers36k views
How would I detect dimerisation in a mazdutide vial without sending it to PeptideMeter?

Setup, so nobody has to ask: dimerisation · mazdutide · PeptideMeter. This is a procedural question rather than a theoretical one, and I would like the procedure…

vial-inspection
vial-inspection

What you can learn by looking: cake morphology, meniscus films, fibres versus stopper fragments versus true particulates, clarity after…

66 questions
peptide-stability
peptide-stability

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

832 questions
harm-reduction
harm-reduction

Reducing avoidable risk where a decision has already been made: independent verification before use, sterility practice, dose arithmetic checked…

445 questions
asked by Dr_Bram_Verhoeven 85k · 2.3 years ago
27 votes 5 answers35k views
How long does dulaglutide stay within specification at 37 °C once reconstituted?

What I am working with: dulaglutide · 37 °C. This is a procedural question rather than a theoretical one, and I would like the procedure rather than the theory. 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
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_two_c 43k · 2.1 years ago
27 votes 5 answers34k views
Does dulaglutide adsorb measurably to the vial wall at 8 mg/mL?

Stated plainly: dulaglutide · 8 mg/mL. I have worked this out and I would like someone to find the error, because I suspect there is one. My working so far, for the…

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 esben_lykke 15k · 2.0 years ago
27 votes 5 answers30k views
Does aspartimide formation of liraglutide at 40 °C show up as a loss of content or of purity?

Conditions: aspartimide formation · 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
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 gel_pack_warm 13k · 20 months ago