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Pharmaceutical Analysis - Overview |
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We provide expert analytical solutions for all stages of pharmaceutical development and manufacturing support processes.
Our mass spectrometry services provide answers in structural analysis and the identification of unknowns using a range of accurate mass instrumentation coupled with preparative HPLC.
We develop methods for a range of analyses from high throughput chemistry using Fast HPLC to more complex stability indicating methods with Mass Spectral detection.
Our growing international reputation in the analysis of extractable components from container/closure systems is built on excellence in mass spectrometric analysis coupled with extensive knowledge of the chemistry involved.
Whilst we excel at technically challenging analyses we also provide analytical solutions for more routine analyses such as Residual Solvents Analysis.
Our laboratory practices and administration systems are MHRA accredited and we have hundreds of satisfied customers within blue
chip pharmaceutical companies.
Our measure of success - repeat business! |
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| Typical Services Available |
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| HPLC / GC Method Development |
Target Compound Identification / Profiling |
- Fast HPLC for Combinatorial analysis
- Target Compound Analysis (MS where required)
- Method Development (GLP)
- Full Method Validation (ICH Q2A, Q2B)
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- Identification & characterization of New Drug Substances (ICH Q6A)
- Metabolite ID
- Extractable Profiles from Container / Closure systems (ICH Q6A)
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| Stability Indicating Analysis |
Production / Process Support |
- Method Development
- Product / Process Related Impurity / Degradant isolation and characterisation (ICH Q3A, Q3B)
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- Residual Solvent Testing (ICH Q3C)
- Process Troubleshooting
- Production Investigation
- Cleaning Validation (Method Development) (CFR 21 Part 211.67)
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| Download the Analytical Services 2008-9 Brochure |
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'Crawford Scientific Analytical Services have provided vital answers to our team through their expertise in characterizing unknown components and their ability to isolate and identify a critical degradation product from our API'
Blue Chip Pharmaceutical Client
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