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Is a 18G drawing needle the right choice for drawing survodutide at 5 mg/mL?

Asked 25 Sept 2024Modified 19 months agoViewed 16k times
21

For reference: an 18G drawing needle · survodutide · 5 mg/mL.

I am trying to choose between two options that are usually discussed as though only one exists.

I am not optimising for price, but I am not indifferent to it either.

So which one, and on what grounds?

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JV
askedjo_vandeberg19k2725 Sept 2024
2Do you have a reference for the last claim? Not disputing it, just want to read it. – coldpack_88 2 months ago
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5 Answers

Accepted answer first, then by votes
76

Accepted answer

Specifically, the distinction that resolves most of these questions is understanding what concentration actually means and why it is not the same as label claim.

The rounding error accumulates if you round too many times — rounding concentration to 5.0, rounding the dose volume to 0.1 mL, rounding the unit reading to 10 — and the safest approach is to work the full precision and round only the final answer.

Reading a lyophilised cake

AppearanceInterpretationAction
Intact opaque puck, proud of baseCycle ran correctlyProceed
Slumped to one sideShipped before fully dry, or vibrationUsually usable; note it
Glassy translucent filmCollapse above glass transitionTest before use
Melt-back ring at stopperThermal excursion in transitTest before use
No visible cake at allVery low fill, or nothing thereWeigh it; query the supplier

Dead space quantified: a fixed-needle insulin syringe holds roughly 3 to 5 µL in the hub and needle after the plunger bottoms out. A luer-lock syringe with a detachable needle holds 35 to 100 µL depending on the hub design. At 5 mg/mL that is 15 to 25 µg lost per draw on the insulin syringe and 175 to 500 µg on the luer-lock — which over ten draws is the difference between losing a rounding error and losing half a milligram.

The Arrhenius relationship for drawing kinetics means that cold solution takes noticeably longer to draw than room-temperature solution.

Write the arithmetic on the vial label. It costs nothing and removes the step where you reconstruct it from memory.

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DH
answered · acceptedDr_Wren_Halliday40k383 Dec 2024
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64

Two people working through the same arithmetic independently should get the same answer, and if they do not, someone has made a unit error.

Air bubbles at these volumes are a measurement problem rather than a safety one. A 2 mm bubble in a 0.3 mL syringe is roughly 4 µL, which at 10 units drawn is a four per cent error.

On filtration: a 0.22 µm syringe filter will remove particulates and organisms, and it will also adsorb a fraction of your peptide onto the membrane — with a low-binding PVDF or PES membrane the loss is typically a few per cent.

Worth noting: the concentration after reconstitution is not the same as the label claim, and most people do not account for the difference.

If in doubt, use more diluent and accept the shorter usable window.

edited 29 Dec 2024 by vialroom — added the placebo-arm figures

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VI
answeredvialroom87k14815 Dec 2024
4Related: the same reasoning applies to the counter-ion question. – Dr_Nadia_Farsi 10 months ago
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31

Write the units at every step, because units errors are the failure mode that catches everyone eventually.

Worked example, because the general form is easier to trust once you have seen it once. Take a 10 mg vial and add 2 mL of diluent: the concentration is 10 ÷ 2 = 5 mg/mL. A 0.5 mg dose is 0.5 ÷ 5 = 0.1 mL. On a U-100 syringe, where 1 unit = 0.01 mL, that is 0.1 ÷ 0.01 = 10 units. Change the diluent to 1 mL and the same dose becomes 5 units — same dose, half the resolution.

Stated carefully, do not use the same needle to pierce the stopper and to administer. The tip is blunted by the stopper, and the hub now contains a dose you are about to lose to dead space anyway.

The content assay results from major testing services show that nominal vial claim and measured content differ by one to ten per cent, making content a driver of dose error.

Do the arithmetic twice, ideally with someone else doing it independently.

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KS
answeredk_szabo45k3822 Nov 2024
26

The single most useful thing to do is write the arithmetic on the vial label, because you will reconstruct it from memory at an inconvenient moment if you do not.

Number of stopper piercings matters less than the gauge doing the piercing. A 30G or 31G needle through a butyl stopper leaves a track that reseals; a 21G or 18G drawing needle punches a core and can drop it into the solution.

I would flag the obvious failure mode: people get the concentration right, get the volume right, and then read the syringe against the wrong scale.

Write the arithmetic on the vial label. It costs nothing and removes the step where you reconstruct it from memory.

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TM
answeredtwo_two_micron15k1711 Nov 2024
24

Dose arithmetic has three parts: concentration from vial content and diluent, volume from dose and concentration, and units from volume and syringe scale.

Rotation of injection site is a tolerability measure, not a pharmacokinetic one, but if you are going to do it you might as well do it right.

The caveat is that this assumes the vial contains what the label says, and if the content assay has not been done, the arithmetic is precise about an unknown quantity.

If in doubt, use more diluent and accept the shorter usable window.

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NO
answerednkem_obiora46k3831 Oct 2024
7Useful. I have added the accept threshold suggestion to my own notes. – RP_C18 7 months ago
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