Compare API to Dietary Supplement Grade

Choose the right ingredient for your patient’s needs

Active pharmaceutical ingredient (API)
Dietary supplement grade
Product Name

XXXXXXX, USP

Product Name

XXXXXXXX, USP (Dietary supplement grade)

System Tagging

CH-API

System Tagging

NU-Dietary

GMP

Drug manufacturer under cGMP including FDA Drug listing

GMP

Manufacturer applicable standards (ISO, Food Registrations etc…)

Certificate of Analysis

Yes

Certificate of Analysis

Yes

Elemental Impurities

Yes

Elemental Impurities

By Manufacturer

Residual Solvents

Yes

Residual Solvents​

Yes

Safety Data Sheet

Yes

Safety Data Sheet

Yes

Testing Methods (If Non-Monograph)

Yes

Testing Methods (If Non-Monograph)

Yes

Stability Data

By Manufacturer and Medisca

Stability Data

N/A

Quality Agreement

Yes

Quality Agreement

N/A

Testing Requirements

Residual solvents and elemental impurities testing once every two years using validated methods

Testing Requirements

Residual solvents testing once every two years

 

 

Regulatory Requirements

Yes - Medisca FDA Drug listing will be available

Regulatory Requirements

N/A - Medisca Drug Listing will not be available

*Full testing on an annual basis and subsequent lots undergo ID testing. Applicable for all three classification.

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