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residual-solvent

Solvents left behind by synthesis and purification - acetonitrile, TFA, DMF, DCM - their ICH limits, how they are measured by headspace GC, and why they are usually absent from a research-grade certificate.

14 questions · sorted by votes

27 votes 5 answers33k views
Is SWB worth the price difference against WuXi TIDES on measured results?

Numbers first: SWB · WuXi TIDES. I have used one of these for a while and I am considering switching, which requires a reason. What I care about is reproducibility,…

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
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
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
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 zeynep_arslan 20k · 18 months ago
27 votes 5 answers25k views
Why is acetate the counter-ion on some lots and TFA on others?

I am comparing a supplier certificate against an independent result on the same lot. The empirical answer seems settled. The explanation does not. If the honest…

acetate-content
acetate-content

Counter-ion content, most often acetate or trifluoroacetate, and why it matters: the counter-ion and residual water are part of the gross mass you…

87 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
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 Dr_Ilse_Vandenberg 78k · 2.0 years ago
22 votes 2 answers7.6k views
How much of the gross mass of a 40 mg oral semaglutide vial is actually peptide?

The case in front of me: 40 mg · oral semaglutide. I want the working, not the result — I need to be able to redo it with different numbers. I care about the…

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
water-content
water-content

Residual moisture in a lyophilised solid, measured by Karl Fischer titration or loss on drying. It drives both the mass balance on a content assay…

39 questions
acetate-content
acetate-content

Counter-ion content, most often acetate or trifluoroacetate, and why it matters: the counter-ion and residual water are part of the gross mass you…

87 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 cold_lane 14k · 13 months ago
21 votes5 answers17k views
Why is a residual-solvent figure almost never on a research certificate?

I have the report as a PDF with the chromatogram on page two, so I can quote specifics. I would like the mechanism, because I want to be able to reason about the…

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
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
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 fill_volume 13k · 2.2 years ago
20 votes 3 answers14k views
What should a certificate of analysis contain to be worth reading?

The lot number on the vial matches the certificate, which at least rules out the easy problem. I have done this once and I suspect I got away with it rather than got…

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
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 linnea_wahlberg 14k · 23 months ago
17 votes 5 answers9k views
Would you re-test cagrilintide after six weeks at 4 °C, or accept the original certificate?

Numbers first: cagrilintide · six weeks · 4 °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
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 carys_meredith 17k · 11 months ago
15 votes 5 answers7k views
What counter-ion should I expect on an HJ oral semaglutide lot?

The case in front of me: HJ · oral semaglutide. The figures are clear enough; the question is what they mean and what they do not. I can supply the numbers if the…

acetate-content
acetate-content

Counter-ion content, most often acetate or trifluoroacetate, and why it matters: the counter-ion and residual water are part of the gross mass you…

87 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
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
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 s_bhattacharya 42k · 4 months ago
14 votes 5 answers20k views
How does dulaglutide behave on a C18 column compared to survodutide?

What I am working with: dulaglutide · a C18 column · survodutide. Both of these get recommended confidently by different people, which suggests neither is obviously…

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
reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

179 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 tare_weight 47k · 11 months ago
10 votes5 answers22k views
Does semaglutide adsorb measurably to the vial wall at 2 mg/mL?

Conditions: semaglutide · 2 mg/mL. I want the working, not the result — I need to be able to redo it with different numbers. I care about the precision as well as 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
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 bounty_hunter_q 18k · 18 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
4 votes 5 answers4.8k views
Is a list of related substances from GGPeps sufficient basis to skip independent testing?

Conditions: list of related substances · GGPeps. I want to decide this in advance so that I am not deciding it under pressure later. Assume I will follow the plan 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
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
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 h_pergande 86k · 32 days ago
4 votes5 answers3.7k views
What does PeptideMeter verification of Hunan Aslsen Technology actually cover?

The particulars: PeptideMeter · Hunan Aslsen Technology. I have the document in front of me and I can read the numbers. What I cannot do is interpret them. I am…

vendor-investigate
vendor-investigate

VendorInvestigate, an independent vendor review and verification service. Use this tag for questions about its verification criteria, what a…

41 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
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
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 Dr_Otto_Lindqvist 38k · 3 months ago
2 votes 5 answers7.5k views
Would you re-test cagrilintide after six weeks at 2–8 °C, or accept the original certificate?

What I have: cagrilintide · six weeks · 2–8 °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
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 teodora_ilic 15k · 5 months ago
2 votes5 answers5.5k views
Is a 95.2% result from VendorInvestigate comparable to 97.9% from Medutest?

Concretely: 95.2% · VendorInvestigate · 97.9% · Medutest. I would like the axes of comparison first and the recommendation second. I have tried the first option and…

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
reference-standard
reference-standard

Certified reference materials and in-house standards: traceability, the certificate of the standard itself, system suitability, and why every…

179 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 Dr_Lena_Ostrowska 42k · 12 months ago
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