Shiva Analyticals Powers Q1/Q2 Reverse Engineering

At Shiva Analyticals, we provide end-to-end scientific and analytical support to help clients successfully execute Q1/Q2-based formulation strategies. Our involvement goes beyond testing—our team delivers interpretation, insights, and regulatory-aligned data that help clients move faster and with greater confidence. 

Shiva Analyticals Support Framework 

1. Comprehensive Excipient Profiling 

We identify all formulation components in the Reference Listed Drug (RLD), including: 

• Active and inactive ingredients 
• Buffers, surfactants, stabilizers 
• Functional excipients 
• Preservatives 
• Viscosity & suspension control agents 

2. Accurate Quantitative Estimation (Q2) 

Using a combination of analytical techniques, we estimate the relative composition and concentration of excipients to help align your formulation with the RLD. 

3. Complete Physical & Functional Characterization 

We evaluate key product attributes, such as: 

• Particle size and morphology 
• Viscosity, rheology & flow 
• Moisture and thermal behaviour 
• Osmolarity, surface tension 
• Polymorphism & crystallinity 

This strengthens the understanding of how material properties influence performance. 

4. Advanced Instrumentation Infrastructure 

Our multi-technique laboratory supports deep analytical investigation using: 

• HPLC/UHPLC 
• LC–MS / GC–MS 
• DSC, TGA, XRD 
• FTIR, Raman 
• Particle size analyzers, BET 
• Karl Fischer and more 

5. Technical Interpretation & Advisory 

Our experienced scientists provide:

• Data interpretation
• Insight into formulation strategy 
• Troubleshooting recommendations 
• Scientific justification for ANDA filing 
• Guidance on next development steps 

6. Faster Development & Reduced Risk 

Our Q1/Q2 studies help formulators: 

• Shorten development timelines 
• Avoid experimental guesswork 
• Reduce formulation failures 
• Improve alignment with the RLD 
• Strengthen scientific defensibility for submissions 

📩 Connect with us today to learn how we can support your Q1/Q2 reverse engineering needs: www.shivaanalyticals.com/en/contact   

About Cotecna

For over 50 years, we have been supporting agriculture, food and pharma, minerals and metals, and consumer products supply chains all over the world. We provide testing, inspection, and certification services to help our clients navigate evolving regulations, ensure product compliance, and support their sustainability journey.

About Shiva Analyticals

Shiva Analyticals is a leading testing laboratory in India, offering precise analytical services across industries such as pharmaceuticals, food, agriculture, and petroleum. Specializing in regulatory compliance and safety, Shiva uses state-of-the-art facilities and cGMP-compliant practices to deliver reliable, tailored solutions that help businesses ensure product quality and meet industry standards.