Our Services
API & Excipient Qualification
Typical Compendial Tests
We have decades of experience in successfully executing method verification, qualification, development and validation for different materials.
ID by FTIR
ID by UV-VIS
ID by GC Retention Time
ID by HPLC Retention Time
ID by FTIR
HPLC Assay
Chromatographic Purity
Specific (Optical) Rotation
Heavy Metals by ICP-OES or ICP-MS
Melting Range
Water Content by Karl Fischer
Titration (volumetric & coulometric)
Titrations (Assays and others)
Impurities and Related Compounds
Limit Tests
Loss on Drying
Loss on Ignition
Ash Content
Residue on Ignition
Conductivity
pH
Ash Content
Residual Solvents
Drug Product Qualification
We have a highly qualified team of analytical experts with decades of experience in both analytical R&D and writing proposals for all stages of analytical development. We have experts in small molecules methods development, methods validation, methods transfer, Stability studies, Author and Review of study Protocols.
Our experts can use your methods, perform full method development, including forced degradation and identification of impurities, and qualification of compendial methods.
Our experts offer strategic vision and develop novel solutions, guiding you through the process to meet your needs in extractables/leachables (E&L) and impurities.
Our experts are fully versed in Extractables and Leachables (E&L) studies on the recommendations of the Product Quality Research Institute’s Extractables and Leachables (E&L) Working Group to the FDA, USP <1663>, USP <1664>, the Bio-Process Systems Alliance Extractables and Leachables (E&L) Subcommittee, FDA container closure guidance, and ISO 10993 Part 18, Biological Evaluation of
Medical Devices.
Preparative Chromatography Services
Typical Method Development and Validation techniques
- Headspace GC
- GC-FID
- GC-FPD
- GC-ECD
- GC-MS
- GC-MS/MS
- GC-HPLC-FLD
- HPLC-UV/PDA
- LC-MS/MS
- UPLC/UV/PDA/MS
- ICP-MS
- ICP-AES
- Flame and graphite AA
- Dissolution
Our experts are well versed on the following Microbiology requirements:
- USP <51> Antimicrobial Effectiveness Testing
- USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
- USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
- USP <87> Biological Reactivity Tests, In Vitro
- USP <1231> Water for Pharmaceutical Purposes
Our experts have extensive experience in Stability Studies
We will help you in customized stability testing that includes developmental and packaging studies, stability protocol design, chromatographic analysis, wet chemistry and dissolution testing.
We have relationship with multiple CROs with qualified stability chambers available at standard ICH conditions below and can customize a chamber for your particular needs:
- -20 °C
- 5 °C
- 25 °C/60% RH
- 30 °C/65% RH
- 40 °C/75% RH
- -70 °C
- Photostability Studies
