September 2016 SPDS Book

Existing Methods (General)

AOAC has 2 Official methods ▪ AOAC SMPR 2014.001 ▪ AOAC SMPR 2012.006

USP has the following methods: ▪ USP 38-NF33 Vitamin K2 MK7 ▪ HPLC methods for pure preparation tablets capsules , , , ▪ USP 29-NF24 Vitamin K1(Phytonadione) ▪ HPLC method for pure, injectable emulsion, tablets

Regulatory Guidance Intake recommendations for Vitamin K are provided in the Dietary Reference Intakes (DRIs) developed by the Food and Nutrition Board (FNB) at the Institute of Medicine of the National Academies.

Adequate intake for Vitamin K

Age

Male

Female 2.0 mcg 2.5 mcg 30 mcg 55 mcg 60 mcg 75 mcg 90 mcg

Pregnancy

Lactation

Birth to 6 months

2.0 mcg 2.5 mcg 30 mcg 55 mcg 60 mcg 75 mcg 120 mcg

7–12 months 1–3 years 4–8 years 9–13 years 14–18 years

75 mcg 90 mcg

75 mcg 90 mcg

19+ years