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SMPR Key Points

Applicability

• Must quantitate

Definition

For this SMPR, active

multiple forms of

vitamin B

12

individually in a

variety of dosage

forms.

vitamin B

12

is defined

as the following:

• Methylcobalamin

• Cyanocobalamin

Adenosylcobalamin

• Must distinguish

active vitamin B

12

corrinoids from

inactive forms.

• Hydroxocobalamin

Matrices for Vitamin B

12

Supplements

• Tablets

• Capsules

• Liquids

• Powders

• Extracts

• Microbial products

• Gummies

• Softgels

• Sublingual forms

• Chewables