In-House Chemical Testing
List Updated: May 11th, 2021
| Test | Method/Details | Sample Size Min |
|---|---|---|
| Weight Variation | Tablets, Capsules, Softgels, Pouches USP<2091> |
20 units |
| Physical Variation Hardness Thickness/Dimensions Particle Size Bulk/Tapped Density |
Hardness Tester Caliper Sieve (US No. 20—200); USP<786> USP<616> |
3 units 3 units 10 g 30 g |
| Disintegration and Dissolution | Tablets, Capsules, Softgels USP<2040> |
12 units |
| Water Determination/ Loss on Drying |
Specify KF, LOD, Moisture Balance USP<921> (Titrimetric) or USP<731> |
5 g |
| Residue | Ignition/Ash; USP<281>/USP<561> | 5 g |
| Melting Point/Range | USP<741> | 2 g |
| Identification (1) Chemical Tests FTIR HPTLC UV/Vis HPLC (2) GC (2) |
USP<191>, USP Monograph USP<197>, USP<854> USP<203>, USP<621>, USP<1064> USP<197>, USP<857> USP<621>, USP Monograph USP<621>, USP Monograph |
10 g 2 g 10 g 10 g 10 g 10 g |
| Assay, Impurities, Other Tests (1) Chemical Tests (2) UV/Vis (2) HPLC (2) GC (2) |
USP Monograph USP<857>, USP Monograph USP<621>, USP Monograph USP<621>, USP Monograph |
10 g 10 g 10 g 10 g |
(1) Capability for test depends upon lab inventory. Tests cannot be performed without required analytical standard, reagents, or solvents for specified test. Inquire prior to sample submission.
(2) If not USP method or other referenced pharmacopeia, only AHF approved or verified testing methods may be performed.
NOTE: Residual Solvents (USP<467>) currently not being tested as sampling instrumentation has not been qualified as of date of this compiled list.