What We Do · Analytical Development
Analytical Development Lab (ADL)
What We Do · Analytical Development
Analytical Development Lab (ADL)
Our Analytical Development Lab provides robust method development, validation and stability testing services that support pharmaceutical product development from early research through commercial release.
All work is aligned with ICH Q2(R1) and current regulatory expectations, ensuring data is submission-ready for global authorities.
Core Capabilities
Integrated services delivered with scientific rigor
01
Method Development & Validation
- Development of assay, impurity and dissolution methods
- Stability-indicating method development
- Analytical method validation as per ICH Q2(R1)
- Method transfer and verification
02
Routine & Release Testing
- Raw material, in-process and finished product testing
- Comparative dissolution profiling (f2)
- In-vitro release testing
- Discriminatory dissolution method development
03
Impurity & Stability
- Impurity profiling and degradation studies
- Forced degradation studies
- Accelerated and long-term stability studies (ICH conditions)
- Stability-indicating chromatographic methods
04
Equipment & Capabilities
- HPLC (UV/PDA), GC and UV–Visible spectrophotometers
- Dissolution test apparatus (USP I/II)
- Karl Fischer titrator
- ICH-compliant stability chambers
Typical Timeline
How a typical engagement unfolds
01
Method development
3–6 weeks
02
Method validation
2–4 weeks
03
Method transfer / verification
1–3 weeks
04
Stability (initial)
6–12 weeks
Timelines are indicative and depend on dosage form, matrix complexity and number of analytes.
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