The Patient Information Leaflets for some Cyanocobalamin injection products, typically in the USA, have references to containing aluminium. Something like this:
This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.
Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a66eb3c4-3e1d-4d49-b963-4fa2334cc9b6
They might then have another statement like:
not more than 57 mcg/l.
This value (or something close) is often regarded as the toxicity limit for aluminium in medicines, food and drink and the statement simply means "This product does not contain a toxic level of aluminium." It does NOT mean that the product contains anything like that much aluminium.
Indeed, all we can really assume is that the company cannot prove there is no detectable aluminium in the product. No responsible company would open themselves up to litigation due to a handful of aluminium atoms being detected in a product. And that warning is required for anything produced for injection that cannot prove it does not contain even a single atom of aluminium.
What if we imagine that the cyanocobalamin ampoule does contain 57 micrograms of aluminium per litre ?
A typical dose of cyanocobalamin is one millilitre. Which is one-thousandth of a litre. If the cyanocobalamin product contained 57 micrograms per litre, that would work out as 0.057 microgram of aluminium per dose. That is, a lesser amount than a tenth of a microgram. In total.
Yet the warning for impaired kidney function is for more than 4 to 5 micrograms of aluminium per kilogram of body weight per day.
To reach that from injections alone, then for each kilogram of your bodyweight you would need around 70 standard cyanocobalamin injections per day. If you weigh 100 kilograms, that would be 7,000 injections per day.
Yet the cyanocobalamin simply will not contain anything like that much aluminium in the first place.
The USP doesn't even have a limit for aluminium as an element in parenteral medicines.
ELEMENTAL IMPURITIES—LIMITS
It's also interesting to consider where any aluminium content comes from. It seems feasible that at least some is introduced by the packaging process which applies an aluminium foil cap over the rubber bung used in multi-dose bottles. (Which might imply that all-glass single dose ampoules really do have no detectable aluminium.)
Apologies for switching between UK and USA spellings! I've used original spellings in quoted text and UK for the rest.
[i][b]helvella - Aluminium in Cyanocobalamin Injections[/b]
An explanation of why the mentioning of aluminium in cyanocobalamin injections products does not imply that the product contains aluminium.
Last updated 13/02/2025[/i]
https://helvella.blogspot.com/p/helvella-aluminium-in-cyanocobalamin.html
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