Analytical Research

Impurity Profile:
Impurities of Drug products, API and intermediates can be studied. Impurities and degradation of products can be studied and unknown impurities can be identified by means of LC-MS and LC-MS-MS analysis. Also, a specified impurity contained within the sample can be isolated, purified and identified using spectral techniques such as NMR, Mass, FTIR, etc.

Reference and Working Standard Qualifications
Reference standards / working standards of impurities and products can be qualified and characterized with the complete report for regulatory submission.

We help in in-house impurity standard generation by means of Degradation and isolation or synthesis and complete characterization by means of potency assignment and structure elucidation.

Genotoxic Evaluation
Genotoxicity of the impurity can be evaluated based on FDA approved software.

Forced Degradation Studies
The Performance of stress studies with the drug substance early in drug development is encouraged, as these studies provide information crucial to the selection of stability-indicating analytical procedures for real time studies.

We provide stress studies by means of hydrolysis, oxidation, photolysis, thermolysis in solution and solid state.

We also provide services for development of stability indicating methods.

Extractable and Leachables
• Extractable and Leachables (both organic and inorganic) study in drug product.
• Development and validation of analytical methods
• Genotoxic and Potential extractable and leachables studies
• Establishment of Specification and acceptance criteria
• Study stability sample for establishment of leachables maximum level
• Qualification of Extractable and Leachables
• Risk Assessment

Other studies performed during stress studies
Stereochemical stability
Chemical and physical stability of polymorphs
Structure elucidation based on LC/MS and chemistry

Compatibility Studies
The drug - excipient compatibility can be studied by subjecting the binary mixtures of drug with different excipients to the differential scanning calorimetric analysis.

Other studies performed during compatibility studies
Stereochemical stability
Chemical and physical stability of polymorphs
Structure elucidation based on LC/MS and chemistry

Chromatographic Method Development and Validation
We have extensive experience in chromatographic method development and validation including reverse phase, normal phase and Chiral HPLC methods and Head space GC methods.

We have expertise in spectroscopic, titrimetric and particle size analysis methods development and method validations.

We also develop and validate analytical methods for cleaning validation. Method validation will be performed using procedures according to current guidelines or customer's specification. We also offer on-site method transfers into our customer's lab by well trained lab stuff.

Polymorphism Studies
Following is the list of studies that can be performed at our laboratory for polymorphism:
• Morphology.
• Identification of polymorph.
• Evaluation of Polymorph for Patent.
• Quantification of Polymorph.
• Indexing and Unit Cell Determination.
• Percentage Crystallinity.
• Equilibrium Solubility.
• Intrinsic Dissolution Profile of the Polymorph.

Lyophilization Studies
Lyophilization studies can be performed to establish isolation procedures of thermally unstable drugs, lipid, enzymes etc. We offer these services up to laboratory scales.

Trace Analysis and Carry over Studies
Trace analysis of impurities like organic, inorganic and residual solvents and their carry over in the finished product can be performed as per regulatory requirements. The report with suitability of the method along with the limits of detection and quantification are provided as per regulatory requirements.

Our strength also lies in reports generation as per Regulatory requirements.