TEENABIOLABS
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Drugs and Pharma Services

We undertake all type of complete analysis and Individual test analysis as per Pharmacopoeial standards and Customer Testing Procedure.

  • Active Pharma Ingredients (Bulk Drugs)
  • Injectables, Syrups, Ointments
  • Formulation Tablets, Capsules
  • Excipients
  • Raw Materials and Packaging Material
  • Intermediates and In-process Samples
  • Herbal products
  • Cosmetics

ANALYTICAL METHOD DEVELOPMENT & VALIDATION

Analytical method development and Validation of analytical methods must be completed to determine performance characteristics for the intended analytical application. Depending on performance characteristics, validation parameters may change. In general, we follow ICH, FDA,USP guidelines for methods validation.

Teena Biolabs has a department of senior level technical team that is dedicated to performing method development and ICH method validation services. Our technical team has years of experience working on stability indicating methods, residual solvent methods, dissolution methods and specific and non-specific cleaning validation methods. We have our own protocols that comply with ICH and FDA guidelines or we can follow client-supplied protocols. Our analytical development services include pharmaceutical method development services and also offer USP method validation services. Teena Bio Labs offers Method Development and validation services using a wide range of technologies including PSD, ICP, HPLC, UV and GC. We have extensive experience in HPLC method development, HPLC validation, GC method development and GC validation. We use these analytical techniques to develop and validate methods for API’s, intermediates, raw materials and finished products. We provide a detailed report at the conclusion of each project. The analytical method which is written in a step-by-step format is included in the report. Our project report includes the following parameters:

  • Precision
  • Intermediate Precision and Ruggedness
  • Linearity
  • Accuracy
  • Range
  • Specificity
  • Forced Degradation Studies
  • Limit of Detection/Limit of Quantization
  • Stability of Standard and Sample Solutions
  • Photo stability study
  • Robustness

TBPL gained years of experience performing all types of Analytical tests on many drug substances, drug products and medical devices. We assure our clients with highest level of quality and attention that their analytical method development and validation projects are successfully executed. Our experience covers the spectrum of pharmaceutical development phase I, II and III.

STABILITY/PHOTO STABILITY STUDIES

  • TBPL has experienced team capable to lead the process from protocol design to storage, monitoring, analytical testing and documentation.
  • A complete range of storage conditions in multiple climatic chambers.
  • The stability units have operational back-ups and are fully controlled with 24x7 monitoring and alert systems.
  • Customer-specific conditions can also be accommodated.
  • Long term and Stress conditions (accelerated). Drug products, drug substance intermediates hold time study.
  • Photo stability studies.

EXTRACTABLE & LEACHABLE STUDIES:

Extractables & Leachables are organic or inorganic impurities originating from primary packaging material or process equipment .

We have scientists with rich experience in performing Extractable & Leachable Studies as per Good manufacturing practices, PQRI recommendations, and FDA guidelines on primary or secondary closure system.

  • Drug delivery systems
  • Medical devices
  • Parenterals
  • Raw materials

    • Techniques We use:

  • LC/MS
  • GC/MS
  • ICP-MS

PHYSICAL CHARECTERIZATION (XRD /DSC /TGA)

  • XRD - X-ray diffraction provides valuable information on polymorphism, degree of crystallinity and amorphous character of solid formulations.
  • TGA - Thermal analysis is a technique in which a physical property of a substance and/or its reaction products is measured as a function of temperature. Thermal analysis can measure weight loss on heating, melting points, heat and energy transitions and change in the substance form.
  • DSC - Differential Scanning Calorimetry is primarily used to determine the energetics of phase transitions and conformational changes and allows quantification of their temperature dependence

TRACE METAL ANALYSIS (ICP-MS/ICP-OES)

  • Trace metal impurities in pharmaceutical products are determined to prevent their harmful effects on patients.
  • We offer elemental analysis using ICP-MS for trace metal analysis.
  • ICP- MS is used to assay trace and ultra-trace elements at part per billion (ppb) levels.

RESIDUAL GENOTOXIC IMPURITY STUDIES (GC-MS / LC-MS)

  • Genotoxins are a challenging class of impurities that have proven to be harmful even at low concentrations and as a result regulatory bodies have specifically defined their limits in drug substances and products.
  • We offer services to detect genotoxic impurities using ICP-MS/LC-MS.