Compendial, physical, chemical and microbiological testing for raw materials, drug substances and finished products.
USP, Ph. Eur., JP, BP, ACS and FCC tests, chosen from the monograph for your material.
See the testsDensity, viscosity, optical rotation, melting range, osmolality and thermodynamic properties.
See the testsElemental impurities and trace metals, iron and residue on ignition.
See the testsSolvents left from synthesis, purification or manufacturing.
See the testsTesting of pharmaceutical water to Ph. Eur., USP and JP requirements.
See the testsHarmonized microbial enumeration and tests for specified organisms.
See the testsTraditional compendial sterility testing, and rapid sterility testing with Celsis.
See the testsAcetic acid in peptides, identity options and peptide mapping.
See the testsCompendial work follows the monograph or specification for your material. Tell us which pharmacopeia and edition apply and we set the tests to match.
| Test | Reference |
|---|---|
| Identity, assay and impurities | |
| Appearance | Per product or monograph |
| Raw material identification | Per product or monograph |
| Raw material assay | Per product or monograph |
| Raw material organic and inorganic impurities | Per product or monograph |
| Physical and physicochemical | |
| pH | Per product or monograph |
| Density | Per product or monograph |
| Specific gravity | Per product or monograph |
| Melting range or temperature | USP <741> |
| Optical rotation | USP <781> |
| Osmolality and osmolarity | USP <785> |
| Viscosity, capillary | USP <911> |
| Viscosity, rotational | USP <912> |
| Completeness of solution | Per product or monograph |
| Sedimentation | Per product or monograph |
| Weight loss | Per product or monograph |
| Water and volatiles | |
| Loss on drying | USP <731> |
| Water determination | USP <921> |
| Water conductivity | USP <645> |
| Elements and residue | |
| Elemental impurities (with validation) | USP <233> |
| Iron | USP <241> Procedure 1 |
| Residue on ignition | USP <281> |
| Dosage forms and containers | |
| Uniformity of dosage units | USP <905> |
| Dissolution | Per product or monograph |
| Uniformity in containers | Per product or monograph |
| Container content | Per product or monograph |
| Peptides | |
| Acetic acid in peptides | USP <503> |
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.
Harmonized microbial enumeration and tests for specified organisms for non-sterile products, and sterility testing for sterile products. 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.
Quoted per project. Established turnaround for routine peptide testing and traditional sterility is listed on the peptide testing page.
Routine peptide purity and identity use HPLC retention time and UV against a reference. LC-MS identity and peptide mapping are separate tests. Acetic acid content in peptides is measured to USP <503>.
Questions about a sample or a method, call 360-967-7010 or email [email protected].
