Testing Service

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Testing Service

Evaluation of products, Comprehensive Testing and services for ensuring the highest quality and regulatory standards.
We wish to be part of the global pharmaceutical development community as we come together by providing the following services:

1- Pharmaceutical / Compendial Testing

We offer a full package chemical analysis service for the quality and safety of the pharmaceutical products like API, Drugs, Excipient, Raw Materials and Packaging as per GMP standards.

Materials testing is required by the regulatory bodies and must follow their respective pharmacopeia monographs or in-house validated methods. Pharmaceutical products and drug substances are analysed as per the latest pharmacopeia (USP, BP, EP, IP. JP) or customer specified procedures and specifications.

  • In- House method and compendial testing (as per IP/BP/USP)
  • Method verification and Method transfer USP <1224>,  USP <1226>
  • Stability Storage and Analysis as per ICH guidelines
  • Dissolution profile in different media (DPDM Profile)
  • Force Degradation Studies
  • Residual Solvent analysis as per USP <467>
  • Impurity Studies USP <233>
  • Formulation Product development studies.
  • Cleaning or residue Method Development and Validations

2- Reverse Engineering

Reverse engineering is the process of analysing and understanding the composition of a Competitor product through testing. Reverse Engineering studies are offered for:

  • Product development
  • Competitor product analysis
  • Confirmation of product identity
  • Analysis of products for specific chemicals
  • Patent infringement investigation

3- Analytical Method development and Validation

Development of analytical methods for new active pharmaceutical ingredients, drug products and excipients is an ongoing requirement for all pharmaceutical industries.

Analytical method development, validation, and transfer are ongoing requirement of any pharmaceutical development program and are important first step to determine that quality of product and for routine sample analysis.

Our team includes lead scientists who have over 20 years’ experience in method development and validation. Based on our extensive experience we can develop the most appropriate method for your product with expectations of regulatory agency.

We specialize in the development of methods for –

  • Stability indicating assay methods
  • Assay of single drugs and multi dose combinations
  • Impurity profiling methods
  • Residue or cleaning method for Single and multidrug
  • Dissolution methods with shorter run time
  • Methods for organic volatile impurities and residual solvents
  • Analytical methods for critical excipients like preservatives and stabilizers
  • Methods for multivitamin formulations

All methods developed by our lab will be validated as per the current requirements ICH guidelines Q2(R1).

4- STABILITY/PHOTO STABILITY/INUSED/DILUTION STUDIES

 We have experienced team to lead the process through stability protocols, coordination for time program, timely pull out and analysis of stability samples.


We provide stabilities studies like Dilution studies, in-used stability, photo stability, long term and stress condition storage and testing services to the pharmaceutical industry.


Our services cover both long and short-term (accelerated) stability programs, as well as stabilities studies like Dilution studies, in-used stability, photo stability studies for both R&D and commercial products. The stability chambers have operational back-ups and are fully controlled with 24×7 monitoring systems.


 Customer-specific conditions can also be accommodated.

5- Pharmaceutical equivalence study 

We having expertise in pharmaceutical equivalence studies for different dosage forms. This includes comparative studies as per product requirement. Comparative studies with marketed/Reference product for quality impacting test/ specifications like:

  • Drug content
  • Impurity profile 
  • Excipients quantification (Q1/Q2
  • Physical Properties like pH, particle size etc..)
  • Dissolution Profile in multi Media

6- Nitrosamine and Genotoxic Impurity Assessment:

We develop and validate the genotoxic impurities by achieving stringent LOQ requirements.

Our process involves the complete development, validation and analysis of genotoxic impurities, precisely assessing them against maximum daily exposure.

we develop methods for new nitrosamine impurities identified by the respective regulatory bodies and meet the latest standards and technology advancements in N-nitrosamine impurity analysis.

7- Elemental Impurity Studies

We provide analysis of the elemental impurities as per ICH Q3D in raw materials, drug substances, excipients, and drug products and helps to deliver with remarkable turnarounds in method development, method validations and batch analysis.

We develop and validate Elemental Impurity analysis as per USP General Chapter <232> and <233> Elemental Impurities- Procedures, ICH Q3D, EMA Guideline or based on customer requirements

8- Extractable and Leachable Studies

During the product development process, it is important to evaluate the potential for components to migrate from container closure systems, manufacturing components or packaging devices into pharmaceuticals solutions.

Regulatory bodies require extractables and leachables (E&L) testing for pharmaceutical drug products and medical devices:

We provide the assessment of extractable and leachable, we have relevant expertise to deliver extractable studies for range of components including:

  • Vials, Stoppers 
  • Gaskets 
  • Pre-filled syringes (PFS)
  • Components used during the manufacture of injectable products like O-Rings, Polymer tubing, LDPE / HDPE bags, Filters etc

We provide the assessment of extractable and leachable in bio/pharmaceutical products as an important step in drug product development and materials qualification procedures.