Why summer is a documented quality problem in this trade
The route did not close because of a rule about peptides.
Cold chain
Page 9 of 15 of this archive, newest first.
The retest date and the expiry date are not the same document
We asked twenty companies three questions about stability data and print every answer, refusal and non-response.
Oxidation, and the peroxide that came in with the surfactant
We describe each pathway in enough chemical detail to explain why it is invisible to the method the trade uses, because that is the part which has practical consequences.
A supplier suspends shipping to New Zealand after 3 consecutive customs detentions
The route did not close because of a rule about peptides.
A supplier suspends shipping to Poland after 11 consecutive customs detentions
The route did not close because of a rule about peptides.
Oxidation, and the peroxide that came in with the surfactant
An isoaspartate rearrangement changes the molecule and not the mass. A method that confirms identity by molecular weight alone will report it as the parent compound.
Benzyl alcohol is a preservative, not a sterilising agent
We set out what is known, what is inferred and what is simply assumed about the fortnight after a vial is opened.
A supplier suspends shipping to New Zealand after 21 consecutive customs detentions
The route did not close because of a rule about peptides.
The degradation product that elutes underneath the parent peak
Reversed-phase chromatography runs in an organic, acidic mobile phase that dissociates most non-covalent aggregates on the way to the detector.
A supplier suspends shipping to Nigeria after 23 consecutive customs detentions
The route did not close because of a rule about peptides.
A supplier suspends shipping to Brazil after 18 consecutive customs detentions
The route did not close because of a rule about peptides.
One vial, four weeks, and the data that does not exist
Every degradation pathway accelerates by orders of magnitude on reconstitution, because the solvent that lyophilisation removed is the reagent most of them need.
A supplier suspends shipping to Switzerland after 14 consecutive customs detentions
The route did not close because of a rule about peptides.
What happens in solution that does not happen in the cake
Every degradation pathway accelerates by orders of magnitude on reconstitution, because the solvent that lyophilisation removed is the reagent most of them need.
The retest date and the expiry date are not the same document
What would make a difference is not a regulator. It is three lines on a certificate, all of which are already known to whoever wrote it.
A supplier suspends shipping to Singapore after 19 consecutive customs detentions
The route did not close because of a rule about peptides.
Twenty-eight days is a number from somebody else’s product
Bacteriostatic water contains benzyl alcohol at 0.9 per cent, which inhibits microbial growth in a preserved multiple-dose presentation. It does not sterilise a contaminated…
A supplier suspends shipping to India after 4 consecutive customs detentions
The route did not close because of a rule about peptides.
A supplier suspends shipping to Nigeria after 20 consecutive customs detentions
The route did not close because of a rule about peptides.
Deamidation is the commonest degradation route and the hardest to see
We describe each pathway in enough chemical detail to explain why it is invisible to the method the trade uses, because that is the part which has practical consequences.