Testing to United States Pharmacopeia (USP) general chapters and monographs for raw materials, drug substances and finished products.
Compendial work follows the monograph or specification for your material. Tell us which pharmacopeia and edition apply and we set the tests to match.
| Chapter | Test | Details |
|---|---|---|
| USP <51> | Antimicrobial effectiveness testing | Microbial challenge studies |
| USP <61> | Microbial enumeration (bioburden) | USP bioburden testing |
| USP <62> | Tests for specified microorganisms | USP bioburden testing |
| USP <71> | Sterility | Sterility testing |
| USP <72> | Rapid sterility testing (respiration-based method) | Sterility testing |
| USP <85> | Bacterial endotoxins | Endotoxin testing |
| USP <233> | Elemental impurities (with validation) | Elements and residue |
| USP <241> | Iron, Procedure 1 | Elements and residue |
| USP <281> | Residue on ignition | Elements and residue |
| USP <467> | Residual solvents by headspace GC-MS | Residual solvents |
| USP <503> | Acetic acid in peptides | Peptide-specific tests |
| USP <643> | Total organic carbon | Request a quote |
| USP <645> | Water conductivity | Water and volatiles |
| USP <731> | Loss on drying | Water and volatiles |
| USP <741> | Melting range or temperature | Physical and physicochemical |
| USP <781> | Optical rotation | Physical and physicochemical |
| USP <785> | Osmolality and osmolarity | Physical and physicochemical |
| USP <788> | Particulate matter | Particulate matter |
| USP <791> | pH | Physical and physicochemical |
| USP <841> | Specific gravity (pycnometer or digital density meter) | Physical and physicochemical |
| USP <905> | Uniformity of dosage units | Dosage units and dissolution |
| USP <911> | Viscosity, capillary | Physical and physicochemical |
| USP <912> | Viscosity, rotational | Physical and physicochemical |
| USP <921> | Water determination | Water and volatiles |
| USP <1113> | Microbial characterization, identification and strain typing | Microbiological screening |
| USP <1223> | Validation of alternative microbiological methods | Sterility testing |
Appearance, identification, assay, organic and inorganic impurities, pH, density, specific gravity and dissolution are run per the product or monograph. See raw material identity, assay and impurities and dosage units, dissolution and containers.
Sterility testing is available by traditional compendial methods and as rapid sterility testing with Celsis. Which method fits depends on the product, and we confirm suitability for your product before reporting.
The material or product, the monograph or specification, the tests you need and the number of lots. We confirm the method, sample amount and price before you ship.
Quoted per project. Established turnaround for routine peptide testing and traditional sterility is listed on the peptide testing page.
Questions about a sample or a method, call 360-967-7010 or email [email protected].
