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coa

Page 29 of 32 · 749 questions tagged coa.

749 questions · sorted by votes · page 29 of 32

5 votes 5 answers12k views
Would you re-test survodutide after twelve weeks at 2–8 °C, or accept the original certificate?

The case in front of me: survodutide · twelve weeks · 2–8 °C. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will follow…

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 tabular_nums 47k · 2.1 years ago
5 votes5 answers11k views
Is a sampling plan from WXT sufficient basis to skip independent testing?

Numbers first: sampling plan · WXT. 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 viable…

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
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
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
peptidemeter
peptidemeter

PeptideMeter, an independent peptide analytics and vendor-rating service. Use this tag for its published datasets, its rating methodology, and how…

14 questions
asked by yuki_morishita 19k · 12 months ago
5 votes5 answers10k views
What does a 98.4% purity with a date of analysis attached let me conclude?

Concretely: 98.4% · date of analysis. I would like to know the limits of what can be inferred from this. What I am trying to avoid is over-reading a single result,…

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
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
hplc
hplc

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

466 questions
asked by tri_gly_ala 48k · 2.0 years ago
5 votes5 answers9.7k views
What does a purity figure on a JEEP report change about how I read it?

What I am working with: purity figure · JEEP. I would like help reading this properly rather than being told what conclusion to reach. I have the full report…

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
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
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by eighty_six_hours 16k · 6 months ago
5 votes 5 answers9.1k views
How do I reconcile 98.8% from Janoshik with 96.4% from the supplier?

Numbers first: 98.8% · Janoshik · 96.4%. Before I write this off, I want to check whether it is a known failure mode. I have the lot number, the certificate and the…

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
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
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
peptidemeter
peptidemeter

PeptideMeter, an independent peptide analytics and vendor-rating service. Use this tag for its published datasets, its rating methodology, and how…

14 questions
asked by jonas_ekstrom 18k · 9 months ago
5 votes 5 answers8.1k views
Why is "semaglutide sodium" a red flag on a compounded label?

The pharmacy is accredited and I have verified that on the accreditor register. I have read the primary source rather than the summary, which has left me with more…

compounding
compounding

Compounded preparations: what a 503A and a 503B facility may legally prepare and when, base versus salt forms, beyond-use dating under USP…

61 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
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
residual-solvent
residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and…

14 questions
asked by cake_collapsed 13k · 2.1 years ago
5 votes 4 answers7k views
How do I read an impurity table on a dulaglutide certificate against the 98.8% headline?

Stated plainly: dulaglutide · 98.8%. The units are where I keep going wrong, so please be explicit about them. I have sanity-checked the order of magnitude and it…

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
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
hplc
hplc

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

466 questions
asked by Dr_Malik_Osei 37k · 7 months ago
5 votes 5 answers6k views
How do I reconcile 97.6% from Janoshik with 95.2% from the supplier?

Numbers first: 97.6% · Janoshik · 95.2%. Before I write this off, I want to check whether it is a known failure mode. I have the lot number, the certificate and the…

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
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
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 area_percent 13k · 3 months ago
5 votes5 answers6k views
How do I read a tirzepatide chromatogram from PeptideMeter beyond the headline number?

The specifics, since they change the answer: tirzepatide · PeptideMeter. I want to understand what this actually establishes, as opposed to what it is being used to…

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
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 petra_hovland 42k · 13 months ago
5 votes 3 answers5.6k views
How many vials from a QST lot should I send for a sterility test?

Concretely: QST · a sterility test. 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…

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
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
cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

261 questions
asked by Dr_Fatima_Belkacem 52k · 7 months ago
5 votes 5 answers5.1k views
What does a chromatogram on an MKM report change about how I read it?

Conditions: chromatogram · MKM. I would like to know the limits of what can be inferred from this. What I am trying to avoid is over-reading a single result, which I…

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
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
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by h_villanueva 50k · 5 months ago
5 votes5 answers4.3k views
Would you re-test oral semaglutide after ten weeks at 25 °C, or accept the original certificate?

The particulars: oral semaglutide · ten weeks · 25 °C. I would like to define my thresholds before I have a result, for obvious reasons. I want a plan with explicit…

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 · 3 months ago
5 votes 5 answers2.9k views
How many vials from an ERP lot should I send for peptide mapping?

Stated plainly: ERP · peptide mapping. The units are where I keep going wrong, so please be explicit about them. I have sanity-checked the order of magnitude and it…

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
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
cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

261 questions
asked by linnea_wahlberg 14k · 4 months ago
5 votes 5 answers2.8k views
Would you re-test tirzepatide after three weeks at room temperature, or accept the original certificate?

For reference: tirzepatide · three weeks · room temperature. I am at the decision point and I would rather think it through than improvise. I would rather spend money…

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 nominal_ten 14k · 2 months ago
5 votes0 answers1.9k views
How many vials from an MKM lot should I send for an endotoxin test?

The specifics, since they change the answer: MKM · an endotoxin test. I would like the arithmetic checked rather than the conclusion asserted. I have deliberately 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
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
cost-analysis
cost-analysis

Cost arithmetic done honestly: cost per milligram after dead-space loss, list versus net price, comparing a multi-dose vial to a fixed-dose pen,…

261 questions
asked by two_two_micron 15k · 7 months ago
5 votes 3 answers1.7k views
Would you re-test survodutide after four weeks at room temperature, or accept the original certificate?

The case in front of me: survodutide · four weeks · room temperature. The failure mode I am trying to avoid is making this decision emotionally. I have twelve months…

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 mass_shift_18 14k · 4 months ago
5 votes0 answers1.4k views
What does a 99.4% purity with a lot-specific certificate attached let me conclude?

Numbers first: 99.4% · lot-specific certificate. This is presented as though it settles something, and I am not convinced it does. I have two documents that appear to…

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
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
hplc
hplc

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

466 questions
asked by liam_bracken 12k · 8 months ago
5 votes0 answers1.2k views
Is a batch certificate the same claim as a vial certificate?

I am comparing a supplier certificate against an independent result on the same lot. Both of these get recommended confidently by different people, which suggests…

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
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
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by unit_math 13k · 7 months ago
4 votes 5 answers24k views
How does SGN compare to WuXi TIDES on documentation quality?

Numbers first: SGN · WuXi TIDES. I want to know what the trade-off actually is rather than which option is fashionable. I would rather have a defensible reason than a…

vendor-comparison
vendor-comparison

Side-by-side comparison of suppliers on measurable axes - independently confirmed purity and content, lead time, cold-chain handling,…

351 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
vendor-vetting
vendor-vetting

Evaluating a supplier on evidence rather than reputation: testing history across batches, whether certificates are batch-specific, how failures…

436 questions
asked by ravi_pillai 16k · 2.1 years ago
4 votes5 answers18k views
How do I reconcile 96.4% from PeptideMeter with 95.2% from the supplier?

The particulars: 96.4% · PeptideMeter · 95.2%. An unexpected observation, and I would like a differential rather than reassurance. The conditions were within what I…

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
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
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 mass_shift_18 14k · 2.0 years ago
4 votes 4 answers13k views
What does 99.4% purity on a wide-pore C18 column actually tell me about a mazdutide vial?

The particulars: 99.4% · a wide-pore C18 column · mazdutide. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I am…

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
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 · 22 months ago
4 votes 5 answers12k views
Would you re-test retatrutide after two weeks at 2–8 °C, or accept the original certificate?

Stated plainly: retatrutide · two weeks · 2–8 °C. I am trying to build something sustainable rather than something thorough that I will abandon. I have already…

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 low_dead_space 42k · 8 months ago
4 votes5 answers10k views
Why does compounded tirzepatide potency vary between pharmacies?

I have the plan documents and the written criteria, which took two calls to obtain. I would like the mechanism, because I want to be able to reason about the cases…

compounding
compounding

Compounded preparations: what a 503A and a 503B facility may legally prepare and when, base versus salt forms, beyond-use dating under USP…

61 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
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 wren_calloway 14k · 23 months ago
4 votes 5 answers9k views
What does a 97.1% purity with a sampling plan attached let me conclude?

Stated plainly: 97.1% · sampling plan. I would like help reading this properly rather than being told what conclusion to reach. I have the full report including the…

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
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
hplc
hplc

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

466 questions
peptidemeter
peptidemeter

PeptideMeter, an independent peptide analytics and vendor-rating service. Use this tag for its published datasets, its rating methodology, and how…

14 questions
asked by rukhsana_iqbal 14k · 10 months ago