September 2016 SPDS Book

SMPR Key Points

Applicability • Must quantitate multiple forms of vitamin B 12 individually in a variety of dosage forms. • Must distinguish active vitamin B 12 corrinoids from inactive forms.

Definition For this SMPR, active as the following: • Methylcobalamin • Cyanocobalamin Adenosylcobalamin • • Hydroxocobalamin vitamin B 12 is defined

Matrices for Vitamin B 12

Supplements

• Tablets • Capsules • Liquids

• Powders • Extracts • Microbial products • Gummies • Softgels • Sublingual forms • Chewables