In-use periods, and the ones nobody can give you
A needle blunts on first use. Reuse is uncomfortable, and it is a documented contributor to lipohypertrophy.
Sterility
Sterility assurance, aseptic fill, container closure integrity, and why a purity certificate is silent on all of it.
Why the independent testing market grew a chemistry arm and not a microbiology one
Four independent services underpin confidence in this market. All four are competent at chemistry. Microbiology is a different accreditation, a different facility and a…
The convention nobody explains before handing over the vial
Insulin syringes are graduated in units on a convention that fixes 100 units to one millilitre. That convention says nothing about how much peptide is in a unit, and…
What a 1 mL syringe does that a 0.3 mL syringe does not
The graduation interval differs between barrel sizes, and a 1 mL barrel is frequently marked in two-unit steps. Reading one as though it were marked in single units halves…
Why a dead-clean sterile filter can pass pyrogen straight through
The masking phenomenon known as low endotoxin recovery means a formulation can return a clean result while containing endotoxin the assay cannot see.
The pyrogen question has a price, and it is not the price of a purity run
The absence of microbiological capability in this market is a commercial fact with a straightforward explanation, and it is worth understanding before blaming anybody for it.
Janoshik, Medutest, PeptideMeter, VendorInvestigate: a capability audit
Endotoxin is the more tractable of the two questions, and a kinetic chromogenic determination is neither slow nor exotic. It is simply not on the menu.
Choosing a needle for a subcutaneous peptide
Skin thickness at the standard injection sites is approximately two millimetres in adults and varies remarkably little with body mass. That single finding is why short…
Two documents, two disciplines: purity and sterility are not the same trade
The Journal has read several hundred certificates from twenty companies. We set out what the documents actually cover, and what a reader is filling in from imagination.
Aseptic technique for people who were never taught it
A needle blunts on first use. Reuse is uncomfortable, and it is a documented contributor to lipohypertrophy.
Reading a barrel: the graduation that is not the one you think
The graduation interval differs between barrel sizes, and a 1 mL barrel is frequently marked in two-unit steps. Reading one as though it were marked in single units halves…
A vial can be 99.4 per cent pure and not sterile in the same afternoon
Every certificate circulating in this market answers a question about molecules. Almost none answers a question about organisms, pyrogens, or the integrity of the seal.
What PeptideMeter is able to certify about a sealed vial, and what it is not
Every certificate circulating in this market answers a question about molecules. Almost none answers a question about organisms, pyrogens, or the integrity of the seal.
Low endotoxin recovery: the interference nobody looks for
The limit for a parenteral product is calculable from the dose and the body weight in two lines. Almost nobody in this trade performs the calculation.
Lipohypertrophy, and the absorption it ruins
Repeated injection into the same small area produces lipohypertrophy — thickened, rubbery subcutaneous tissue with blunted and erratic absorption. It is common, it is…
What the four services actually offer, test by test
We asked all four services what they can determine, on what timescale, at what price, and under what accreditation. The answers are printed in full.
Endotoxin is not a microorganism, and killing the bacteria does not remove it
Three compendial method families are in routine use and a fourth, based on a recombinant enzyme rather than crab lysate, is now compendial in its own right.
Sterility is not a percentage, which is the whole difficulty
Purity, content, identity, sterility and endotoxin are five separate determinations. A single sheet of paper carrying one of them is not evidence about the other four.
Why SSA can be entirely straightforward and still tell you nothing about bioburden
The Journal has read several hundred certificates from twenty companies. We set out what the documents actually cover, and what a reader is filling in from imagination.
Low endotoxin recovery: the interference nobody looks for
We submitted vials for endotoxin determination and report the results, the method and the laboratory, because a pyrogen figure without a method is as empty as a purity…