Retinol palmitate 632 views0 applications

Australian approved name (AAN): Retinol palmitate

Common names and synonyms: Retinyl palmitate; Vitamin A palmitate; Vitamin A

Superseded AAN: Retinyl palmitate

Molecular formula: C36H60O2

Molecular weight: 524.86

Conversions (% retinol): 54.58

Conversions for each unit:
1mg = 546µgRE
1mg = 1818.18IU
1IU = 0.55µg
1µgRE = 1.832µg

RDI as retinol equivalents per NHMRC:
Infants – 0-6 months – 250µg/day retinol (as retinyl esters) (AI)
Infants – 7-12 months – 430µg/day RE (AI)
Children – 1-3 years – 300µg/day
Children – 4-8 years – 400µg/day
Children – 9-13 years – 600µg/day
Boys – 14-18 years – 900µg/day
Girls – 14-18 years – 700µg/day
Men – 900µg/day
Women – 700µg/day
Pregnancy – 14-18 years – 700µg/day
Pregnancy – 19-50 years – 800µg/day
Lactation – 1100µg/day

Mandatory component: Vitamin A

Maximum daily dose: When for internal use the MRDD must be no more than 3000µg RE of Vitamin A. When for topical use the concentration of Vitamin A in the medicine must be no more than 1%.

Warnings and restrictions: When divided preparations for internal use in adults contain more than 33µg of Retinol Equivalents per dosage unit the medicine requires the following warnings on the label:

VITA2 – WARNING: If you are pregnant – or considering becoming pregnant – do not take vitamin A supplements without consulting your doctor or pharmacist [or words to that effect]. NOTE: Position this warning at the beginning of the directions for use.

VITA4 – WARNING: When taken in excess of 3000micrograms retinol equivalents – vitamin A can cause birth defects. NOTE: Position this warning at the beginning of the directions for use.

VITA3 – The recommended daily amount of vitamin A from all sources is 700micrograms retinol equivalents for women and 900micrograms retinol equivalents for men.

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:
VIT – Vitamins can only be of assistance if the dietary vitamin intake is inadequate. or Vitamin supplements should not replace a balanced diet.

Allowable purpose of the ingredient: Active. Excipient

TGA reference: International Non-Proprietary Name (modified)

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