Advanced, cGMP-Compliant Analytical Services for Pharmaceutical, Nutraceutical, and Biopharmaceutical Products

Taj Pharma’s Analytical Solutions Division supports the entire lifecycle of pharmaceutical product development—from R&D to commercial manufacturing—through comprehensive testing, validation, characterization, and regulatory-compliant data generation. With a state-of-the-art cGMP analytical facility and a highly skilled scientific team, Taj Pharma ensures that all analytical operations meet the strictest global regulatory requirements, including WHO-GMP, PIC/S, MHRA, USFDA, EMA, and ICH guidelines.

Our analytical infrastructure serves as a cornerstone for formulation development, quality assurance, regulatory filings, and global batch release, ensuring precision, reproducibility, and safety of all products manufactured under the Taj Pharma umbrella.

1. Comprehensive Analytical Service Capabilities

1.1 Extractables & Leachables (E&L) Studies

E&L studies are critical for ensuring the compatibility of pharmaceutical products with primary packaging systems, dosage delivery devices, and container-closure components.

Taj Pharma performs:

  • Controlled extraction studies using multi-solvent conditions
  • Simulated and accelerated leachable studies under ICH stability
  • Identification and quantification using HRMS (Orbitrap), GC-MS/MS, LC-MS/MS
  • Toxicological risk assessment and safety qualification
  • Container–closure integrity & material chemistry evaluation

Applications include:

  • Prefilled syringes
  • Injectables & ophthalmics
  • Blister packs, HDPE containers
  • IV sets, infusion bags
  • Elastomeric closures

Our robust E&L program supports:
cGMP, ICH Q3E, ISO 10993, PQRI, and USP <1663>/<1664> compliance

1.2 Nitrosamine & NDSRI Impurity Analysis

Taj Pharma is equipped with sophisticated analytical platforms for monitoring Nitrosamines and Nitrosamine Drug Substance-Related Impurities (NDSRIs) across drug substances and finished products.

Capabilities include:

  • Ultra-sensitive quantification up to ppt–ppb levels
  • Screening of all known nitrosamines including NDMA, NDEA, NMBA, NDIPA, NEIPA, NDBA
  • Detection of emerging NDSRIs using HRMS-Orbitrap, LC-MS/MS, and GC-MS/MS
  • Root-cause investigation & degradation pathway mapping
  • Nitrosamine risk assessment per ICH M7, EMA/169921/2019, USFDA guidance
  • Verification of mitigation strategies during process validation

This ensures regulatory compliance with the latest global nitrosamine limits.

1.3 Method Development, Validation & Technology Transfer

Taj Pharma’s analytical scientists develop robust methods for:

  • Assay & purity
  • Related substances
  • Dissolution
  • Stability-indicating methods
  • Genotoxic impurity analysis
  • Chiral impurity profiling
  • Residual solvent analysis
  • Particle size & crystallinity evaluation

Method Validation follows ICH Q2(R2):

  • Specificity
  • Accuracy
  • Linearity
  • Precision (repeatability & intermediate precision)
  • Robustness
  • Detection & quantification limits (LOD/LOQ)

Technology Transfer ensures seamless migration of analytical methods to production QA/QC labs with:

  • Comparative method performance assessment
  • System suitability criteria alignment
  • Transfer protocols and training
  • Pre-approval readiness for regulatory audits

1.4 Stability and Release Testing

Taj Pharma’s cGMP stability program supports:

  • Accelerated and long-term studies under ICH Q1A
  • Zone II, IVa, and IVb conditions
  • Real-time data tracking via 21 CFR Part 11-compliant systems
  • Photostability studies as per ICH Q1B
  • Stress degradation studies for impurity qualification

Stability data is integrated into CTD Modules 3.2.P.8 and 3.2.S.7, supporting global submissions.

Release testing covers:

  • Assay
  • Related impurities
  • Dissolution
  • Content uniformity
  • Physical parameters
  • Microbiological analysis (where needed)

1.5 QC Testing for Batch Release

Quality Control laboratories at Taj Pharma operate under strict cGMP, GLP, and ISO 9001:2018 frameworks.

QC testing includes:

  • Raw material testing (API, excipients)
  • Packaging material testing
  • In-process quality checks
  • Finished product testing
  • Water system monitoring (PW, WFI, Pure Steam)

We maintain:

  • Validated analytical methods
  • Real-time data integrity controls
  • Trend analysis & deviation management
  • Out-of-specification (OOS) investigations per regulatory standards

Batch release is executed only after QA review and compliance certification.

1.6 Genotoxic Impurity, Degradation, Dissolution & NG Tube Studies

Genotoxic Impurity Analysis

  • ICH M7-compliant GTI screening
  • Ultra-trace detection using LC-MS/MS and Orbitrap
  • Structural identification and fate studies

Degradation Pathway Analysis

  • Stress testing (acid/base, oxidation, thermal, photolytic)
  • Mass balance studies
  • Impurity qualification & toxicological risk evaluation

Dissolution Studies

  • Method development for IR, ER, DR formulations
  • Apparatus I & II USP
  • Biorelevant media (FaSSIF/FeSSIF)
  • IVIVC strategy alignment

NG Tube & Compatibility Studies

  • Product recovery & compatibility for nasogastric (NG) administration
  • Evaluation of crushing, dispersion & tube passability
  • Impact on assay, impurity profile, and dissolution

These services are essential for pediatric, geriatric, and hospital-use formulations.

2. Advanced Analytical Instrumentation at Taj Pharma

Our laboratory employs a complete suite of high-end instrumentation to ensure precision and reproducibility:

Mass Spectrometry Platforms

  • HRMS (Orbitrap): For structural elucidation, unknown impurity identification, and ultra-trace detection
  • LC-MS/MS: For nitrosamines, genotoxic impurities, and stability degradation analysis
  • GC-MS/MS: For volatile impurities, residual solvents, and extractables

Elemental Analysis

  • ICP-MS: ppm–ppb level detection of elemental impurities (as per ICH Q3D)
  • AAS: For metals analysis with high sensitivity

Chromatography Systems

  • HPLC (PDA/UV/RID/FLD detectors): Routine and advanced testing
  • Ion Chromatography (IC): For anions, cations & counter-ions
  • GC: Residual solvents and volatile component analysis

Physical Characterization

  • Particle Size Analyzer (PSD): Laser diffraction for blend & dispersion control
  • PXRD: Polymorph identification and crystal structure characterization
  • Dissolution Testers: USP I and II for dissolution profiling
  • Karl Fischer Titrators: Moisture content determination (coulometric & volumetric)

Stability Infrastructure

  • ICH-compliant stability chambers
  • Data integrity secured via 21 CFR Part 11-compliant digital systems

These instruments ensure Taj Pharma delivers high-resolution, regulatory-compliant analytical data across all formulations.

3. Data Integrity, Compliance & Documentation Excellence

Taj Pharma’s analytical operations follow robust systems ensuring integrity, traceability, and audit readiness.

Key controls include:

  • ALCOA+ principles for all data (Attributable, Legible, Contemporaneous, Original, Accurate)
  • Electronic data capture and audit trails
  • SOP-driven operations
  • Periodic instrument qualification (IQ/OQ/PQ)
  • Comprehensive documentation for CTD, eCTD, and ANDA submissions

Our analytical reports are fully suited for:

  • MOH regulatory filings
  • International dossier submissions
  • Partner audits
  • Market authorization support
  • Tech-transfer packages

4. Why Taj Pharma’s Analytical Solutions Stand Out

  • Extensive portfolio of complex impurity testing capabilities, including nitrosamines and genotoxic impurities
  • Fully equipped for stability, release, and E&L studies
  • Strong expertise in supporting formulations for regulated markets
  • End-to-end analytical lifecycle support from R&D to commercial QA/QC
  • Commitment to data integrity and regulatory compliance
  • High throughput with advanced automation and global-standard instrumentation

Taj Pharma’s Analytical Solutions division plays a pivotal role in ensuring product safety, efficacy, and global regulatory compliance. With world-class instrumentation, expert scientists, and robust cGMP systems, the analytical facility delivers precise, validated, and trustworthy data essential for formulation development, batch release, regulatory submissions, and market authorization across the world.