12 Dedicated Analytical Testing Verticals • cGLP Aligned

Comprehensive Testing.
Engineered for Regulatory Clearance.

Explore our full spectrum of specialized laboratory testing services with dedicated analytical protocols, 21 CFR Part 11 compliant computerized data integrity, and qualified instrumentation.

12 Individual Service Protocols
Standard 3–5 Days Turnaround
21 CFR Part 11 Audit Integrity
IP, BP, USP, EP & JP Pharmacopoeias
Showing 12 of 12 Analytical VerticalsNeed custom protocol? Speak with QA Director
ICH Q2(R1) & FDA Aligned

Method Validation & Lifecycle

Satvam Research provides comprehensive analytical method development, validation, verification, and transfer for pharmaceuticals, APIs, and ...

Custom method design and chromatographic parameter optimization
Full validation parameter matrix conforming to ICH Q2(R1)
Method verification of compendial pharmacopeial monographs (USP, EP, BP, IP)
ICH Q2(R1) Validation of Analytical ProceduresFull Method Specs
ICH Q3D & USP <232>/<233>

Elemental Impurities (ICH Q3D)

Satvam Research provides trace elemental impurities screening conforming to ICH Q3D, USP <232>/<233>, and FDA guidelines. Utilizing our Lab ...

Screening and quantitative determination of Class 1 elements: As, Cd, Pb, Hg
Quantitation of Class 2A elements: Co, Ni, V
Quantitation of Class 2B elements: Tl, Au, Pd, Ir, Os, Rh, Ru, Se, Ag, Pt
ICH Q3D Guideline for Elemental ImpuritiesFull Method Specs
ICH Q1A(R2) & Q1B Photostability

Stability & Shelf-Life Studies

Satvam Research provides accelerated, intermediate, and real-time stability testing for pharmaceutical formulations, APIs, cosmetics, and bo...

Accelerated conditions: 40°C ± 2°C / 75% RH ± 5% RH
Intermediate conditions: 30°C ± 2°C / 65% RH ± 5% RH
Real-time conditions: 25°C ± 2°C / 60% RH ± 5% RH (Zone II) and 30°C ± 2°C / 75% RH (Zone IVb)
ICH Q1A(R2) Stability Testing of New Drug Substances and ProductsFull Method Specs
ICH Q3C & USP <467>

Residual Solvent Analysis (GC/GCHS)

Satvam Research performs high-sensitivity residual solvent profiling and volatile organic analysis complying with ICH Q3C and USP <467>. Uti...

Class 1 Solvents: Benzene, Carbon tetrachloride, 1,2-Dichloroethane, 1,1-Dichloroethene
Class 2 Solvents: Acetonitrile, Chlorobenzene, Chloroform, Hexane, Methanol, Pyridine, Toluene
Class 3 Solvents: Acetone, Ethanol, Ethyl acetate, IPA, MEK
ICH Q3C(R8) Impurities: Guideline for Residual SolventsFull Method Specs
ICH Q3A/B & Compendial

Related Substances & Assay (HPLC)

Satvam Research provides high-resolution chromatographic assay and related substances determination for Active Pharmaceutical Ingredients (A...

Finished dosage form assay (tablets, capsules, syrups, topicals, injectables)
Related substances and chromatographic purity profiling
Impurity peak identification via PDA spectral library matching
ICH Q3A(R2) Impurities in New Drug SubstancesFull Method Specs
IP, BP, USP, EP, JP

Compendial Monograph Testing

Satvam Research conducts complete compendial monograph evaluation as per Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United State...

Identification tests: FTIR fingerprinting, UV absorption, colorimetric reactions
Physical constants: Melting point, boiling range, optical rotation, refractive index
Assay and potency: Potentiometric titration, HPLC, GC, non-aqueous titration
Indian Pharmacopoeia (IP) Current EditionFull Method Specs
HEPA-Filtered Cleanroom

Cleanroom Microbiology (MLT)

Satvam Research operates an environmentally controlled, HEPA-filtered cleanroom microbiology vertical dedicated to Microbial Limit Testing (...

Total Aerobic Microbial Count (TAMC) and Total Combined Yeasts and Molds Count (TYMC)
Absence testing for Escherichia coli, Salmonella species, Pseudomonas aeruginosa, Staphylococcus aureus
Bile-tolerant gram-negative bacteria enumeration and testing
USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration TestsFull Method Specs
IS 10500 : 2012 Standalone Department

Water Testing (IS: 10500)

Satvam Research operates a dedicated standalone water testing department executing physical, chemical, and microbiological water analysis st...

Complete physical parameters: pH, Turbidity, Total Dissolved Solids (TDS), Electrical Conductivity
Chemical parameters: Total Hardness, Alkalinity, Chlorides, Sulfates, Nitrates, Fluorides
Demand & Oxygen parameters: Biological Oxygen Demand (BOD), Chemical Oxygen Demand (COD), Dissolved Oxygen
IS 10500:2012 Drinking Water Specification (Second Revision)Full Method Specs
USP Apparatus 1 & 2

Dissolution & Oral Dosage Testing

Satvam Research provides in-vitro dissolution profiling and tablet/capsule physical characterization adhering to USP, BP, and IP standards. ...

Single-point batch release dissolution testing as per compendial monograph
Multi-point dissolution profiling (10, 15, 20, 30, 45, 60 minutes) in diverse buffers
Calculation of Difference Factor (f1) and Similarity Factor (f2) for biowaivers
USP <711> DissolutionFull Method Specs
Malvern Mastersizer 3000+ Ultra

Particle Size Analysis (PSD)

Satvam Research provides particle size distribution (PSD) metrics utilizing the world-standard Malvern Mastersizer 3000+ Ultra laser diffrac...

Dry powder dispersion analysis for free-flowing solids and granulations
Wet liquid dispersion analysis in aqueous and non-aqueous dispersants with sonication
Automated determination of D10, D50, D90, Span, and Sauter Mean Diameter (D[3,2])
USP <429> Light Diffraction Measurement of Particle SizeFull Method Specs
Mettler Toledo & Lab India

Physicochemical & Wet Chemistry

Satvam Research provides comprehensive physicochemical characterization and classical wet chemistry testing. Using Mettler Toledo and Lab In...

Karl Fischer (KF) moisture titration for hygroscopic powders and non-aqueous liquids
Specific optical rotation [α] determination for chiral and optically active compounds
Digital refractive index (nD) at controlled 20°C / 25°C temperatures
USP <921> Water DeterminationFull Method Specs
ISO 10993 & Medical Devices

Medical Device Safety Testing

Satvam Research provides residual ethylene oxide (ETO) testing and biocompatibility chemical characterization for sterilized medical devices...

Exhaustive extraction and simulated-use extraction of sterilized medical devices
Quantitation of Residual Ethylene Oxide (ETO)
Quantitation of Ethylene Chlorohydrin (ECH)
ISO 10993-7 Biological Evaluation of Medical Devices – Ethylene Oxide Sterilization ResidualsFull Method Specs
21 CFR Part 11 Qualified Hardware

Advanced Analytical Instrumentation

Governed from installation to performance through strictly validated IQ/OQ/PQ qualifications

Particle Size Analyzer - Mastersizer 3000+ Ultra
Physical Characterization
Malvern Panalytical

Particle Size Analyzer

Model: Mastersizer 3000+ Ultra

Laser diffraction-driven particle size distribution (PSD) metrics with wet and dry dispersion modules for sub-micron to millimeter particle characterization.

Sub-micron to 3500 µm range
High-speed laser diffraction
Wet & dry dispersion
HPLC Systems - Prominence LC-2080C
Chromatography
Shimadzu

HPLC Systems

Model: Prominence LC-2080C

Equipped with UV, PDA, and Refractive Index (RID) detectors for chromatographic purity, related substances, organic impurities, and assay of raw materials and finished goods.

UV, PDA & RID detectors
21 CFR Part 11 software
Ultra-low carryover
GC & Headspace (GCHS) - Nexis GC-2050 & GC-2014C
Chromatography
Shimadzu

GC & Headspace (GCHS)

Model: Nexis GC-2050 & GC-2014C

High-sensitivity FID and TCD detection for volatile organic analysis, residual solvent profiling (including Residual ETO, Ethylene Glycol), and gas purity determination.

FID & TCD detectors
Automated Headspace Sampler
Trace volatile detection
ICP-OES - ICP 5000DV
Elemental Analysis
Lab India

ICP-OES

Model: ICP 5000DV

Comprehensive elemental analysis and dual-view plasma spectroscopy for trace heavy metal monitoring and elemental impurities evolution satisfying ICH Q3D & FDA guidelines.

Dual-view plasma
Sub-ppb trace detection
Full ICH Q3D element panel
Microwave Digestion System - MARS 6
Sample Preparation
CEM Corporation

Microwave Digestion System

Model: MARS 6

Closed-vessel high-pressure microwave sample preparation supporting total recovery, precise sample breakdown, and complex matrix digestion for downstream ICP-OES profiling.

High-throughput closed vessels
Precise temperature & pressure control
Zero trace loss
FTIR Spectrophotometer - IRSpirit-X
Spectroscopy
Shimadzu

FTIR Spectrophotometer

Model: IRSpirit-X

High-resolution Fourier-transform infrared spectroscopy for structural identification, raw material fingerprinting, and polymer/compound verification.

High S/N ratio
ATR & transmission modes
Compendial compliance
UV-Vis Spectrophotometer - UV-1900i PLUS
Spectroscopy
Shimadzu

UV-Vis Spectrophotometer

Model: UV-1900i PLUS

Double-beam spectrophotometer with ultra-fast spectral scanning for quantitative photometric assay, dissolution kinetics, and structural identification.

Double-beam optical system
Ultra-fast wavelength scan
Full regulatory compliance
Automated Dissolution Tester - DS 14000
Oral Dosage Testing
Lab India

Automated Dissolution Tester

Model: DS 14000

Multi-stage automated dissolution profiling for solid oral dosage forms, evaluating active drug release characteristics over time compliant with USP, BP, and IP monographs.

Multi-vessel automated sampling
Precise temperature management
USP Apparatus 1 & 2 compliant
Tablet Disintegration Tester - DT 2000S
Oral Dosage Testing
Lab India

Tablet Disintegration Tester

Model: DT 2000S

High-precision evaluation of tablet and capsule break-down profiles under tightly controlled thermal monitoring, supported by hardness and friability instrumentation.

Simultaneous basket operation
Real-time temperature display
Compendial adherence
Stability & Photostability Chambers - Climate-Controlled Environmental Chambers
Stability Studies
Mack Pharma Tech

Stability & Photostability Chambers

Model: Climate-Controlled Environmental Chambers

Specialized climate-controlled chambers for real-time, accelerated, and photostability profiling across all ICH climate zones with 24/7 continuous data logging.

ICH Climatic Zones I-IVb
Integrated Photostability UV/VIS
Automated alarm & backup
Polarimeter, Refractometer & Auto-Titrator - Precision Lab Suite
Wet Chemistry & Physicochemical
Lab India / Mettler Toledo

Polarimeter, Refractometer & Auto-Titrator

Model: Precision Lab Suite

Digital polarimeter for optical rotation, digital refractometer, melting point apparatus, and Karl Fischer & auto-titrator for accurate moisture and purity determination.

Karl Fischer moisture analysis
Digital optical rotation
Automated potentiometric titration
Microbiological Cleanroom Suite - Environmentally Controlled Cleanroom
Microbiology
SRPL Engineered

Microbiological Cleanroom Suite

Model: Environmentally Controlled Cleanroom

HEPA-filtered cleanroom infrastructure dedicated to Microbial Limit Tests (MLT), TAMC, TYMC, pathogen absence verification, and environmental bioburden monitoring.

HEPA air filtration
Biosafety laminar hoods
Zero cross-contamination design
Rapid Turnaround Testing

Need a Custom Protocol or Batch Release Testing?

Contact our scientific team in Vapi today to discuss onboarding timelines, standard method compliance, or to coordinate courier sample pickup.

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