Scientech Laboratories has experience with and validated methods for working with a broad portfolio of product forms, active ingredients, excipients, and other product additives. Scientech has an extensive list of validated methods and qualified equipment to operate in a cGMP compliant environment. Representative examples of product forms, actives, other ingredients, methods, and instrumentation are provided in the following listings.
Instrumentation & Analytical Techniques
USP <191> — Identification Tests—General
USP <197> — Spectroscopic Identification Tests
USP <271> — Readily Carbonizable Substances Test
USP <281> — Residue on Ignition / Sulfated Ash
USP <621> — Chromatography (HPLC, GC adjustments, system suitability)
USP <786> — Particle Size Distribution Estimation by Analytical Sieving
USP <851> — Spectrophotometry and Light-Scattering
USP <857> — Ultraviolet–Visible Spectroscopy
Physical / Chemical Tests
USP <201> — Thin-Layer Chromatographic Identification Test
USP <401> — Acid Value (Free Fatty Acids), Ester Value, Hydroxyl Value, Iodine Value, Peroxide Value, Saponification Value
USP <611> — Alcohol Determination
USP <616> — Bulk & Tapped Density of Powders
USP <645> — Water Conductivity
USP <651> — Congealing Range or Temperature
USP <659> — Packaging and Storage
USP <731> — Loss on Drying
USP <741> — Melting Range or Temperature
USP <781> — Optical Rotation
USP <791> — pH
USP <841> — Specific Gravity
USP <905> — Uniformity of Dosage Units
USP <911> & <912> — Viscosity
USP <921> — Water Determination (Karl Fischer)
Impurities
USP <232> & <233> — Elemental Impurities — Limits
USP <281> — Sulfated Ash / ROE (often used for metals screening)
USP <467> — Residual Solvents
USP <1469> — Nitrosamine Impurities
Performance Tests
USP <701> — Disintegration
USP <711> — Dissolution
USP <2040> — Disintegration / Dissolution for Dietary Supplements
Microbiology (Analytical Labs that Test Microbial Limits)
USP <51> — Antimicrobial Effectiveness Testing (Preservative Challenge Test)
USP <60> — Microbiological Examination of Nonsterile Products: Burkholderia cepacia Complex
USP <61> — Microbial Enumeration Tests (TAMC/TYMC)
USP <62> — Tests for Specified Microorganisms
USP <85> — Bacterial Endotoxins Test
USP <1112> — Application of Water Activity Determination
USP <2021> — Microbial Enumeration for Dietary Supplements
USP <2022> — Absence of Specified Microorganisms — Dietary Supplements
Packaging & Extractables/Leachables
USP <661.1> — Plastic Materials of Construction
USP <661.2> — Plastic Packaging Systems for Pharmaceutical Use
USP <665> — Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products
USP <1663> — Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
USP <1664> — Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems
USP <1665> — Characterization and Qualification of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products
Method Validation/Verification
USP <1224> — Transfer of Analytical Procedures
USP <1225> — Validation of Compendial Procedures
USP <1226> — Verification of Compendial Procedures