Analys Lab

We at Analys truly appreciate the significance of Analytical Method Development & Validations. Backed by extensive experience, we are capable of offering individualised solutions to meet client requirements. The highlights of our endeavours in this domain include:

• Method development and validation services for Raw material, Intermediates, API's and Finished dosages
• Individualised method development & validations devised to meet client specific requirements
• Procedures aligned to meet cGMP standards and performed in compliance with ICH guidelines
• Method optimization and modification to ensure successful validations
• Method Transfers executed as per clients' requirements

Led by a dedicated team of vastly experienced scientists, quality control specialists and quality assurance experts, Analys offers a wide spectrum of regulatory compliant Analytical Testing Services. Also, by ensuring swift turnaround times we invariably are helping our clients to enjoy the early-to-market advantage. Our expertise in this domain spans across:

• Typical Drug Assays
• Related substances studies
• Stability Studies
• Limit Tests
• Residual solvents
• Physico-chemical characteristics
• Impurities identification - APIs/Finished Dosages

• IP, USP, BP, EP, JP & Ph. Int.
• Excipient analysis
• Elemental impurities screening including rare
• earth elements and catalyst residues

• FTIR, DSC and TGA etc
• State of the art XRPD technology for analyses of :
  a) Qualitative Analysis
  b) Polymorph Quantification with unmatched detection limits
  c) % Crystalline & % Amorphous Studies
  d) Foil Transmission measurements
  e) Capillary Transmission measurements
  f) Variable Temperature & Variable Humidity measurements
• Thermal Testing
  a) Differential Scanning Calorimetry (DSC), modulated DSC
  b) Thermogravimetric Analysis (TGA)
  

Powered by the most sophisticated equipment, Analys is fully geared to handle Trace Metal Analyses with precision. Through effective utilisation of Inductively Coupled Plasma – Mass Spectrometry (ICP-MS), we can track down the presence of trace elements at part per billion (ppb) levels. Our endeavours are further reinforced by IC (Ion Chromatography) and AAS (Atomic Absorption Spectroscopy) which facilitate qualitative determination of Ionic Species and Chemical Elements respectively.

The sphere of Extractable & Leachable (E&L) Studies assumes significance in the light of increasing scrutiny by regulatory bodies which take into account the overall impact of product's packaging material on product stability, safety and efficacy.

The team at Analys has demonstrable experience of developing and delivering E&L assessments tailored to meet the requirements of clients. We offer a wide range of E&L studies encompassing:

• Parenterals/Injectables
• Solid/Liquid Orals Containers
• Packing components
• Material Compatible Studies etc.

The techniques adopted by Analys for the E&L assessments include:

• GCMS/MS (volatiles/semi-volatiles)
• LCMS/MS (non-volatiles)
• ICP-MS (Elemental Impurities)

The Microbiology Lab, helmed by a distinct team of experts caters to an array of high-quality testing services. The laboratory - designed to be compliant with cGMP & cGLP norms - consists of class 100 laminar flow hoods, class 10,000 clean rooms for sterility testing and class 1,00,000 clean rooms for microbial testing.

The range of microbiology services includes:

• Indoor Air Quality Testing
• Clean room Environmental Monitoring
• Microbial limits test (MLT) validation and routine testing
• Bacterial endotoxin test (BET), validation and routine testing
• Water testing
• Disinfectant shelf life evaluation and efficacy tests
• Bacterial identification test by Vitek 2 compact system

A host of water quality tests are offered at Analys to fulfil regulatory requirements in addition to evaluating safety as per national and international standards. The services include:

• Physical Characteristics Studies
• Chemical & Microbiological Assessments
• Heavy metals and inorganic contaminant Investigations