Compare APIs to nutraceutical grades

Choose the right ingredient for your patient’s needs

Active pharmaceutical ingredient (API)
Premium supplement grade
Product Name

XXXXXXX, USP

Product Name

XXXXXXX, USP (Premium supplement grade)

System Tagging

CH-API

System Tagging

NU-Premium

GMP

Drug manufacturer under cGMP including FDA Drug listing

GMP

Drug manufacturer under cGMP including FDA Drug listing

Certificate of Analysis

Yes

Certificate of Analysis

Yes

Elemental Impurities

Yes

Elemental Impurities

Yes

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

By Manufacturer

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 and elemental impurities are tested once every two years using validated methods

Regulatory Requirements

Yes - Medisca FDA Drug listing will be available

Regulatory Requirements
Yes - Medisca FDA Drug Listing will be available

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

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