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Chemical Discipline
FDCA Form 37 Approved21 CFR Part 11 Compliant
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Chemical Analysis

Comprehensive wet chemistry and physico-chemical testing for pharmaceuticals, water, food, and industrial samples.

Wet ChemistryPhysico-ChemicalTitrimetry
Turnaround Time3–7 working days
Sample TypesPharma, Food, Water, Industrial
StandardsUSP, IP, EP, ASTM, ISO
Report FormatCoA / Test Report
● Lab Capacity ActiveForm 37 Certified

Study Protocol Support

Direct access to analytical specialists for study design, method validation, and turnaround timelines.

Submit Sample MatrixDownload Service Spec Sheet
Direct Technical Desk:+91 76240 54108
Service Scope & Regulatory Framework

Rigorous Scientific Execution Built for Global Regulatory Dossiers

Our chemical analysis services cover a broad range of physico-chemical and wet chemistry tests for pharmaceutical, food, water, and industrial samples. From basic pH and moisture determination to advanced titrimetric and spectroscopic analyses, our laboratory provides accurate and reliable results following pharmacopoeial and international standards.

Compendial Standards & Regulatory Alignment:
✓ USP✓ IP✓ EP✓ ASTM✓ ISO
Dual-Analyst Review

100% 4-eye verification of all chromatograms, integrations, and calculations before CoA generation.

ALCOA+ Data Integrity

Direct electronic data capture with immutable audit trails, restricted rights, and disaster backups.

Technical SpecificationscGLP Compliant

Turnaround Time3–7 working days
Sample TypesPharma, Food, Water, Industrial
StandardsUSP, IP, EP, ASTM, ISO
Report FormatCoA / Test Report
Quality Credentials
FDCA Gujarat Form 37ICH Compliant (Q1–Q14)21 CFR Part 11
Key Analytical Capabilities

What's Covered in the Testing Scope

Comprehensive assay, stability, and characterization endpoints validated to global pharmacopoeial standards.

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pH, conductivity, and osmolalityExecuted with validated SOPs and full raw data audit trails.
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Water content by Karl Fischer titrationExecuted with validated SOPs and full raw data audit trails.
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Loss on drying and ignitionExecuted with validated SOPs and full raw data audit trails.
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Optical rotation and specific gravityExecuted with validated SOPs and full raw data audit trails.
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Viscosity and rheologyExecuted with validated SOPs and full raw data audit trails.
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Acid value, saponification valueExecuted with validated SOPs and full raw data audit trails.
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Titration (acid-base, redox, complexometric)Executed with validated SOPs and full raw data audit trails.
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Melting point and boiling pointExecuted with validated SOPs and full raw data audit trails.
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Refractive indexExecuted with validated SOPs and full raw data audit trails.
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Particle size distributionExecuted with validated SOPs and full raw data audit trails.
Qualified Laboratory Infrastructure

Validated Instrumentation & Data Systems

All instruments operate with full IQ/OQ/PQ qualification, automated audit trails, and 21 CFR Part 11 software packages.

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Karl Fischer Titrator

Water content determination

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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Polarimeter

Optical rotation measurement

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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Viscometer (Brookfield)

Viscosity determination

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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pH Meter / Ion Analyzer

pH, conductivity, ion analysis

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
Study Execution Lifecycle

How We Execute Your Study

Standardized 4-stage laboratory workflow ensuring traceability from sample intake to CoA release.

01
Stage 01

Test Plan Preparation

Test parameters identified based on sample type and regulatory requirements.

02
Stage 02

Sample Preparation

Appropriate sample preparation performed per pharmacopoeial method.

03
Stage 03

Analysis

Tests performed in triplicate with calibrated instruments and certified standards.

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Stage 04

Report Issuance

Results compiled with acceptance criteria comparison; CoA or test report issued.

Scientific Questions & Answers

Technical FAQs

Standard testing is delivered in 3–7 working days. Expedited priority slots are available upon request with dedicated instrument reservations and expedited QC review.
Ready for Sample Testing?

Initiate Your Chemical Analysis Study

Submit your sample matrix or request a pre-study analytical protocol discussion with our senior scientists today.

Schedule Scientific Consultation
Cross-Discipline Solutions

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ICH Q3D-compliant testing of elemental impurities in APIs, drug products, and raw materials using ICP-OES and ICP-MS.

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Residual Solvent Testing

Headspace GC and direct injection GC methods for Class 1, 2, and 3 residual solvents in APIs and drug products.

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Pharmaceutical Testing

Complete testing of APIs, formulations, excipients & finished products as per USP, EP, BP, IP, and ICH guidelines.

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