New USP-NF name for Capryol® monographs
We did not change our excipients, it’s just their USP names that have changed!
Capryol® is Gattefossé tradename for Propylene glycol monocaprylates. As for December 1st 2021, USP names for propylene glycol monocaprylates have changed. Find in the following table the names you can use in the transition period and the names to be used from December 1st 2026 on.
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USP names |
Level of propylene glycol monocaprylate |
Gattefossé excipient tradename |
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|
before 2021/12/01 |
from 2021/12/01 |
from 2026/12/01 |
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|
Propylene glycol monocaprylate (Type II) |
Propylene glycol monocaprylate or Propylene glycol monocaprylate (Type II) |
Propylene glycol monocaprylate |
> 90% |
Capryol® 90 |
|
Propylene glycol monocaprylate (Type I) |
Propylene glycol mono and dicaprylate or Propylene glycol monocaprylate (Type I) |
Propylene glycol mono and dicaprylate |
55-80% |
Capryol® PGMC |
Also new for Capryol® 90 is the Inactive Ingredient Database listing including the Maximum Daily Exposure of 24 mg in oral tablets.
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|
FDA Inactive ingredient database (http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm) |
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EXCIPIENT NAME |
Inactive ingredient |
UNII number |
Route |
Dosage form |
Maximum Potency per unit dose |
Maximum Daily Exposure (MDE) |
|
CAPRYOL® 90 |
PROPYLENE GLYCOL MONOCAPRYLATE |
RT9P9S09QI |
Oral |
TABLET, FILM COATED |
|
24 mg |
Note that the level listed in the FDA IID for the maximum potency and maximum daily exposure are referring to a specific product on the market. These levels do not constitute a regulatory max use level. And indeed, in another market reference a higher level of use (299 mg/capsule) is claimed in the Patient Information Leaflet.
Contact us if you need more information on the history of use of our excipient!
