Consulting on Elemental Impurities

In January 2018, new guidelines for identifying elemental impurities in drug substances, excipients, and drug products came into effect.

Ensuring Compliance with Expert Elemental Impurities Consulting.

Scientech consults with its partners and clients on the requirement of types of Elemental Impurity analysis.

USP <232> and ICH Q3D sets forth specifications for drug products which involves the determination of metallic impurities in APIs and excipients.

cGMP

cGMP compliant

FDA registered

DEA licensed

Documentation