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peptide-stability

Page 5 of 35 · 832 questions tagged peptide-stability.

832 questions · sorted by votes · page 5 of 35

33 votes 5 answers40k views
Would you re-test mazdutide after six weeks at 30 °C, or accept the original certificate?

Details up front: mazdutide · 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 the minimum…

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 dead_volume 49k · 18 months ago
33 votes 5 answers39k views
Does dimerisation dominate for a GLP-1 receptor agonist held at 2–8 °C?

What I am working with: dimerisation · a GLP-1 receptor agonist · 2–8 °C. 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
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 haze_check 17k · 17 months ago
33 votes5 answers36k views
Does deamidation of ecnoglutide at 37 °C show up as a loss of content or of purity?

For reference: deamidation · ecnoglutide · 37 °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 per_haugen 18k · 18 months ago
33 votes 5 answers31k views
How would I detect oxidation in a tirzepatide vial without sending it to Janoshik?

Conditions: oxidation · tirzepatide · Janoshik. 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…

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 bac_or_bust 37k · 13 months ago
33 votes5 answers25k views
How would I detect deamidation in a semaglutide vial without sending it to Medutest?

The specifics, since they change the answer: deamidation · semaglutide · Medutest. I have read the obvious sources and they disagree with each other, so I would…

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 petra_hovland 42k · 17 months ago
33 votes 5 answers25k views
What happens to orforglipron after eight weeks at 30 °C in solution?

Stated plainly: orforglipron · eight weeks · 30 °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
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_Aoife_Brennan 50k · 20 months ago
33 votes 5 answers23k views
How many freeze-thaw cycles will mazdutide at 10 mg/mL tolerate?

What I have: mazdutide · 10 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 and…

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 tamsin_wray 13k · 13 months ago
33 votes 5 answers23k views
What happens to liraglutide after ten weeks at 40 °C in solution?

The specifics, since they change the answer: liraglutide · ten weeks · 40 °C. I would like the mechanism, because I want to be able to reason about the cases 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 siobhan_deasy 16k · 15 months ago
33 votes0 answers21k views
My mazdutide vial sat at 40 °C for twenty-eight days — is testing worth it before use?

What I have: mazdutide · 40 °C · twenty-eight days. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if someone can tell me…

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 marta_szymanska 17k · 12 months ago
33 votes2 answers21k views
Is survodutide at 8 mg/mL stable enough for ten weeks of multi-withdrawal use?

The case in front of me: survodutide · 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…

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 ivo_paunovic 15k · 16 months ago
33 votes2 answers20k views
How many freeze-thaw cycles will cagrilintide at 6.67 mg/mL tolerate?

Details up front: cagrilintide · 6.67 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…

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 jonas_ekstrom 18k · 15 months ago
33 votes4 answers18k views
Would you re-test oral semaglutide after three weeks at 40 °C, or accept the original certificate?

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

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 tadhg_o_riordan 14k · 12 months ago
33 votes2 answers16k views
Is room temperature an acceptable storage condition for lyophilised orforglipron?

Details up front: room temperature · orforglipron. I would rather be corrected now than propagate something wrong. I am specifically not interested in a testimonial;…

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 cal_hennessy 14k · 15 months ago
33 votes 4 answers16k views
What happens to tirzepatide after ten weeks at minus 80 °C in solution?

For reference: tirzepatide · ten weeks · minus 80 °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 marcus_thorbjorn 16k · 12 months ago
33 votes 4 answers15k views
Does orforglipron adsorb measurably to the vial wall at 3.33 mg/mL?

Setup, so nobody has to ask: orforglipron · 3.33 mg/mL. I have worked this out and I would like someone to find the error, because I suspect there is one. My working…

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 zeynep_arslan 20k · 20 months ago
32 votes 5 answers59k views
Is there any published stability data for mazdutide at minus 20 °C?

Details up front: mazdutide · minus 20 °C. I would rather be corrected now than propagate something wrong. I am specifically not interested in a testimonial; 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
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 vial_five 15k · 23 months ago
32 votes5 answers54k views
Would you re-test oral semaglutide after three weeks at 25 °C, or accept the original certificate?

For reference: oral semaglutide · three weeks · 25 °C. I am at the decision point and I would rather think it through than improvise. I would rather spend money on…

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 coldbox9 13k · 20 months ago
32 votes 5 answers53k views
Would you re-test tirzepatide after ten weeks at 30 °C, or accept the original certificate?

For reference: tirzepatide · 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 stopping…

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 cake_intact 18k · 19 months ago
32 votes 5 answers44k views
How many freeze-thaw cycles will cagrilintide at 2.5 mg/mL tolerate?

Numbers first: cagrilintide · 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…

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 area_percent 13k · 2.2 years ago
32 votes 5 answers39k views
Does tirzepatide adsorb measurably to the vial wall at 4 mg/mL?

For reference: tirzepatide · 4 mg/mL. I would rather understand the derivation than memorise the outcome. Two people I asked gave two answers that differ by a factor…

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 ilaria_bertone 43k · 15 months ago
32 votes 5 answers38k views
Would you re-test cagrilintide after sixteen weeks at room temperature, or accept the original certificate?

Details up front: cagrilintide · sixteen weeks · room temperature. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if…

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 two_point_four 14k · 2.1 years ago
32 votes 4 answers37k views
How long should full dissolution take, and what if it is slower?

I keep a written log of every draw with date, volume and syringe type. I want a method I can write down and repeat, not a rule of thumb. I would rather over-engineer…

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
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 amara_nwachukwu 41k · 23 months ago
32 votes 2 answers30k views
Does dimerisation dominate for a GLP-1 receptor agonist held at 37 °C?

What I am working with: dimerisation · a GLP-1 receptor agonist · 37 °C. 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
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 zeynep_arslan 20k · 13 months ago
32 votes0 answers30k views
What happens to cagrilintide after sixteen weeks at minus 80 °C in solution?

Details up front: cagrilintide · sixteen weeks · minus 80 °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 rukhsana_iqbal 14k · 21 months ago