Analytical/Stability

Analytical/Stability


Mascot offers analytical services for both small and large molecules for discovery and development processes across pharmaceuticals, fine chemicals, agro chemicals and other products using a variety of spectroscopic, chromatographic and physiochemical techniques.

All the services can be provided as per GMP/ GLP compliant studies as per clients’ requirements.

Mascot specializes in:
Developing high throughput analytical methods for mid and large scale combi-chem library molecules
Semi-preparatory and preparatory purification, impurity isolation, structural elucidation and characterization

In addition, we can also support method development, method transfer, method validation, characterization studies, in-process, lot release and stability analysis.

The work can be carried out in support of R&D or custom synthesis projects or as stand-alone services. There are separate labs for research-level analytical development/characterization and for fully-compliant GMP/GLP analytical work.

Analytical methods for product testing or stability testing can be developed and validated in house or transferred in from the client and validated in house. Validated methods can also be transferred in and verified through formal protocols.

Mascot has hands-on experience to develop and optimize methods at our cGMP compliant analytical facilities, equipped with an array of tools and techniques. Mascot can also support analytical method validation as per ICH guidelines (ICH Q2R1) and can cater to any client-specific needs.

Our capabilities include:

Analytical Method Development

Small Molecules
Purity analysis by HPLC, UPLC and GC
Reaction monitoring using UPLC-MS and GC-MS
Quantitative NMR analysis
Potency
Impurities - Residual solvents and organic impurities
Physical and chemical tests
Cleaning assessment
Chiral purity
Others as requested

Biologics (Biochemical and biological analysis and characterization)
Bioassays: Potency by in-vitro cell based and non-cell based assays
Analysis of impurities and variants
Related proteins by RP-HPLC
Charge heterogeneity and isoforms by IEX, cIEF
Slab gel electrophoresis & Capillary electrophoresis (CE) - CGE, CZE, IEF
Imaged Capillary Electrophoresis- IEF (iCE 280)
Aggregate quantitation by SEC, DLS
SDS-PAGE, Capillary gel electrophoresis
Process impurities
Host cell DNA
Host cell protein
Residual Protein-A
Residual process additives
Structural characterization
Identity of protein by Mass spectrometry
Glycoform analysis
PTM analysis
Glycosylation site determination
Peptide mass fingerprinting and amino acid sequencing
Secondary and higher order structure by CD, fluorescence
Analytical Method Validation
Chromatographic method validation
Non-chromatographic method validation
Immunological assays validation
Bioassay validation

Mascot supports structure elucidation of compounds by using various chromatographic techniques as well as spectrometric techniques like MS, MS/MS, 1D and 2D NMR.

Our structure elucidation service includes:
Initial rapid structure profiling using LC/MS and isolation or purification
Detailed structural studies using MS/MSn ion trap fragmentation techniques to further investigate the structure of the molecule
High sensitive NMR analyses to obtain full 1D and 2D homo and hetero nuclear NMR data for detailed structural information
Excellent data interpretation skills of experienced MS and NMR scientists
Customized analytical chemical testing & structure elucidation

Mascot prepares working reference standards by selecting the highest purity material from different batches of the same product against the official reference standards. If the official reference standards are not available, Mascot qualifies the material subjecting it to additional purification.

Mascot offers full spectrum support for characterizing the compounds as mentioned below:

Purity and Assay by HPLC/GC
Identification by FTIR/LCMS/UV
Water content
DSC
TGA
XRD
1H-NMR
13C-NMR
2D NMR
ROI
Heavy metals by ICP-OES/USP method
Elemental analysis

Mascot develops either a suitable method or adapts an existing method for impurity isolation and characterization. Isolation of the impurities can be executed with preparatory HPLC using various detectors such as UV/ELSD/MS or supercritical fluid preparatory chromatography followed by detailed structure elucidation using MS and NMR techniques.

The results from impurity characterization studies can be presented as a formal report suitable for regulatory submissions. In addition, Mascot can characterize and potentially identify impurities and degradation products present in API. Impurities above 0.10% are also isolated or purified using prep HPLC/ prep SFC techniques.

Mascot supports a broad and comprehensive range of preparative HPLC services. We offer isolation, purification and concentration of single components from crude samples or from complex mixtures. The compounds of interest can be purified up to multi gram level with ultrapure quality (≥99%).

We carry out high-throughput purification for small as well as large scale library molecules using mass based auto-purification. We also have the capability for separation of multi gram quantity of chiral compounds using preparative SFC.

Mascot supports Residual Solvent Analysis for manufacturing process to meet ICH limits. Mascot can develop a method for residual solvent analysis, either by GC (auto liquid injector) or GC- Head space sampler.

Mascot supports method verification or method transfer process. It transfers the validated methods between laboratories and sites to maintain their validated state to ensure the same reliable results in the receiving laboratory.

Our offerings include:
Transferring the validated methods from the originating labs to the receiving labs
Protocol preparation by originating lab scientist to carry out the experiment in presence of the receiving lab scientist and vice-versa
Method transfer activities which includes receiving lab set methods
Comparative testing
Co-validation between the two labs
Complete or partial method validation

Mascot's stability team conducts studies in accordance with ICH guidelines and client requirements. Material for stability testing can be provided by clients or produced/packaged at Mascot.

Our offerings include:
Full range of stability storage conditions for the four world climatic zones
Stability studies under accelerated / stress conditions using standard ICH conditions
Stability studies under controlled conditions from -20°C to + 40°C and a range of humidity conditions from 60% RH to 75 % RH
ICH photo stability
Expertise in Stability Studies of APIs, Biologics, and Formulations

Mascot has capabilities to perform the physical-chemical tests required as per regulatory requirements. We offer full services for 5batch testing of agrochemical active ingredients to meet world-wide regulatory compliance. Mascot can conduct more than 10 5Batch analysis and method validation annually according to different regulatory requirements.

Our offerings include:
Method development/Method transfer
Non GLP screening and impurity profiling by gradient HPLC or GC
Method validation
Quantification of active ingredients and impurities
Confirmation of identity

Mascot supports Residual Solvent Analysis for manufacturing process to meet ICH limits. Mascot can develop a method for residual solvent analysis, either by GC (auto liquid injector) or GC- Head space sampler.