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peptide-stability

Page 10 of 35 · 832 questions tagged peptide-stability.

832 questions · sorted by votes · page 10 of 35

26 votes 5 answers29k views
Does reconstituting mazdutide with 0.9% sodium chloride change anything I should know about?

Details up front: mazdutide · 0.9% sodium chloride. I suspect the usual explanation for this is wrong, or at least incomplete. I am aware this may have a boring…

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 nils_karlberg 13k · 2.2 years ago
26 votes 5 answers28k views
Would you re-test oral semaglutide after three weeks at 4 °C, or accept the original certificate?

The specifics, since they change the answer: oral semaglutide · three weeks · 4 °C. I am at the decision point and I would rather think it through than improvise. 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 micron22 36k · 2.0 years ago
26 votes4 answers27k views
My a GLP-1 receptor agonist vial sat at 30 °C for twenty-eight days — is testing worth it before use?

Numbers first: a GLP-1 receptor agonist · 30 °C · twenty-eight days. I would rather over-plan the first cycle and simplify later. I am prepared to do the work if…

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
26 votes 5 answers25k views
Would you re-test orforglipron after eight weeks at minus 20 °C, or accept the original certificate?

Stated plainly: orforglipron · eight weeks · minus 20 °C. I would like to set this up properly once, rather than adjust it repeatedly. My budget is real but not…

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 swirl_dont_shake 19k · 13 months ago
26 votes 5 answers19k views
How would I detect aspartimide formation in an oral semaglutide vial without sending it to Janoshik?

Conditions: aspartimide formation · oral semaglutide · Janoshik. I am trying to do this correctly the first time rather than learn it by getting it wrong. I have…

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
endotoxin
endotoxin

Bacterial endotoxin: LAL and kinetic chromogenic methods, how an endotoxin limit is derived from a dose, why endotoxin survives autoclaving, and…

14 questions
asked by area_percent 13k · 6 months ago
26 votes0 answers16k views
Is there any published stability data for semaglutide at minus 20 °C?

The case in front of me: semaglutide · minus 20 °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…

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 area_percent 13k · 15 months ago
26 votes0 answers15k views
Would you re-test a GLP-1 receptor agonist after sixteen weeks at 4 °C, or accept the original certificate?

What I have: a GLP-1 receptor agonist · sixteen weeks · 4 °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 Dr_Elias_Weiss 46k · 22 months ago
26 votes 5 answers14k views
How many freeze-thaw cycles will dulaglutide at 2 mg/mL tolerate?

What I am working with: dulaglutide · 2 mg/mL. Everything I have found on this is either a forum aside or a product page, neither of which I trust. I am comfortable…

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 tri_gly_ala 48k · 10 months ago
26 votes 5 answers14k views
Does deamidation dominate for semaglutide held at room temperature?

The specifics, since they change the answer: deamidation · semaglutide · room temperature. I would like the mechanism, because I want to be able to reason about 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
hplc
hplc

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

466 questions
asked by dermot_kiely 14k · 7 months ago
26 votes 5 answers13k views
How many freeze-thaw cycles will tirzepatide at 4 mg/mL tolerate?

For reference: tirzepatide · 4 mg/mL. 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…

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 cake_collapsed 13k · 16 months ago
26 votes 5 answers11k views
Does fibrillation dominate for semaglutide held at 40 °C?

The specifics, since they change the answer: fibrillation · semaglutide · 40 °C. I understand the observation; what I do not understand is the mechanism behind it. 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 pk_curve 12k · 13 months ago
26 votes 4 answers9.3k views
Is 2–8 °C an acceptable storage condition for lyophilised cagrilintide?

Setup, so nobody has to ask: 2–8 °C · cagrilintide. This is asserted often enough that I assumed it was established, and then I went looking for the source. I have…

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 day_seven_trough 11k · 10 months ago
26 votes 5 answers8.6k views
Is orforglipron at 5 mg/mL stable enough for six weeks of multi-withdrawal use?

Stated plainly: orforglipron · 5 mg/mL · six weeks. This has the shape of a fact but I cannot find its origin. What I found instead were three secondary sources all…

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 u100_marks 38k · 10 months ago
26 votes 3 answers8.2k views
Would you re-test ecnoglutide after twelve weeks at 30 °C, or accept the original certificate?

Concretely: ecnoglutide · twelve weeks · 30 °C. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will follow the plan 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 swab_stopper 16k · 7 months ago
26 votes 5 answers7.2k views
Is semaglutide at 3.33 mg/mL stable enough for three weeks of multi-withdrawal use?

Concretely: semaglutide · 3.33 mg/mL · three weeks. I want to know whether there is evidence behind this or only repetition. I have checked the obvious registries and…

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 two_two_micron 15k · 5 months ago
26 votes0 answers5.5k views
What happens to retatrutide after eight weeks at 2–8 °C in solution?

What I am working with: retatrutide · eight weeks · 2–8 °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
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 loss_on_drying 47k · 6 months ago
25 votes 5 answers52k views
How long does survodutide stay within specification at 2–8 °C once reconstituted?

The case in front of me: survodutide · 2–8 °C. I am trying to do this correctly the first time rather than learn it by getting it wrong. I have already made 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
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 nils_karlberg 13k · 2.1 years ago
25 votes 5 answers42k views
Does hydrolysis dominate for orforglipron held at 25 °C?

Numbers first: hydrolysis · orforglipron · 25 °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
hplc
hplc

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

466 questions
asked by ilaria_bertone 43k · 18 months ago
25 votes 5 answers41k views
How many freeze-thaw cycles will cagrilintide at 10 mg/mL tolerate?

What I have: cagrilintide · 10 mg/mL. I can find plenty of assertions about this and almost no reasoning, which is usually a sign that nobody has checked. Assume no…

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 fiadh_cronin 14k · 19 months ago
25 votes 5 answers37k views
My mazdutide vial sat at minus 80 °C for seven days — is testing worth it before use?

Numbers first: mazdutide · 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 I want is 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 otto_brenner 19k · 19 months ago
25 votes 5 answers37k views
Does ecnoglutide adsorb measurably to the vial wall at 8 mg/mL?

Conditions: ecnoglutide · 8 mg/mL. Please show the division. I want to check my own against yours. I would like the general form as well as the specific number, so I…

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 · 23 months ago
25 votes5 answers36k views
Does aspartimide formation of oral semaglutide at room temperature show up as a loss of content or of purity?

Concretely: aspartimide formation · oral semaglutide · room temperature. This is one of those things that everyone repeats and nobody derives. This matters…

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 colm_dunphy 16k · 22 months ago
25 votes 5 answers32k views
My a GLP-1 receptor agonist vial sat at minus 20 °C for seven days — is testing worth it before use?

Numbers first: a GLP-1 receptor agonist · minus 20 °C · seven days. This is a planning question. I know what my options are; I do not know how to weigh them. What I…

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 jana_horakova 15k · 17 months ago
25 votes5 answers29k views
My semaglutide vial sat at 25 °C for twenty-one days — is testing worth it before use?

Conditions: semaglutide · 25 °C · twenty-one days. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months in view and I would…

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 swab_and_wait 15k · 13 months ago