Analytical Services

Precision, Accuracy, and Compliance at Every Step

At Amoli CDMO, analytical excellence forms the backbone of our development and manufacturing processes. Our Analytical Services Division ensures that every compound, intermediate, and API we produce meets the highest global standards for quality, purity, and consistency.

By integrating state-of-the-art instrumentation, data integrity systems, and a science-driven approach, we provide our partners with reliable and reproducible results — enabling faster approvals, reduced risks, and enhanced confidence in every batch.

Comprehensive Analytical Capabilities

Our analytical laboratories are equipped with modern infrastructure to support the complete lifecycle of product development — from method development through routine release testing and stability studies.

Core Analytical Capabilities include:

• Method Development, Optimization, and Validation (ICH Q2(R2) compliant)
• Identification and Quantification of Impurities (organic, inorganic, residual solvents)
• Assay and Content Uniformity
• Dissolution and Stability Testing (Accelerated and Long-Term)
• Physicochemical Characterization (pH, DSC, XRPD, PSD, Hygroscopicity)
• Residual Solvent Analysis (GC and Headspace GC)
• Chiral Purity Analysis
• Trace Metal Analysis (ICP-MS)
• Microbiological Testing Support
• Forced Degradation and Stress Studies
• Cleaning Validation Analytical Support

Our laboratories employ advanced instrumentation such as HPLC, UHPLC, GC, LC–MS/MS, UV–Vis, IR, KF titration, and NMR, operated by a team of experienced analytical chemists trained in regulatory and compliance standards.

Analytical Method Development and Validation

Amoli follows a structured, risk-based approach to Analytical Method Development and Validation in line with ICH Q2(R2), FDA, and EMA expectations.

Our analytical scientists collaborate closely with process development and formulation teams to establish robust, phase-appropriate methods that are specific, precise, accurate, linear, and reproducible.

Our Method Validation Protocol covers:

1. Specificity and Selectivity – Ensuring the method accurately measures the target analyte without interference.
2. Linearity and Range – Demonstrating proportional response over the intended concentration range.
3. Accuracy and Precision – Confirming consistency across multiple analysts, days, and instruments.
4. Limit of Detection (LOD) & Limit of Quantitation (LOQ) – Defining sensitivity parameters for trace impurity quantification.
5. Robustness and Ruggedness – Assessing the method’s reliability under varied experimental conditions.
6. System Suitability & Data Integrity Checks – Verifying compliance before each run using validated electronic systems.

Our validation process is documented through comprehensive protocols and summary reports, ensuring complete traceability for regulatory audits and submissions.

Regulatory and Data Integrity Compliance

All analytical operations at Amoli are performed under cGMP, with full adherence to 21 CFR Part 11 and ALCOA+ data integrity principles.

We maintain electronic data management systems, audit trails, and secure archival practices to support global regulatory submissions.

Amoli’s analytical documentation is audit-ready and structured to meet the expectations of agencies such as USFDA, EMA, MHRA, PMDA, and WHO.

Stability and Release Testing

Amoli offers stability studies under ICH Q1A(R2) conditions to support drug substance and drug product shelf-life determination.

We conduct real-time, accelerated, and intermediate stability programs using validated methods and controlled environmental chambers.

In addition, our Quality Control (QC) laboratories perform in-process and release testing of intermediates, APIs, and finished products in compliance with GMP requirements — ensuring consistency and reliability throughout the manufacturing lifecycle.