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Pharma Discipline
FDCA Form 37 Approved21 CFR Part 11 Compliant
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Pharmaceutical Testing

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

USPICHAPI TestingFormulations
Turnaround Time5–10 working days
Sample QuantityAs per pharmacopoeia
Report FormatCoA / Full Test Report
Regulatory AcceptanceUSFDA, EU, India submissions
● 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

Jarvogen provides comprehensive pharmaceutical testing services for Active Pharmaceutical Ingredients (APIs), drug formulations, excipients, and finished products. Our state-of-the-art laboratory is equipped with advanced analytical instruments and operated by experienced scientists following cGLP practices. We support pharmaceutical companies through all stages of drug development and regulatory submissions.

Compendial Standards & Regulatory Alignment:
✓ ICH Q2(R1)✓ USP✓ EP✓ BP✓ IP✓ FDA Guidelines
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 Time5–10 working days
Sample QuantityAs per pharmacopoeia
Report FormatCoA / Full Test Report
Regulatory AcceptanceUSFDA, EU, India submissions
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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API identification and characterizationExecuted with validated SOPs and full raw data audit trails.
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Assay and related substances by HPLCExecuted with validated SOPs and full raw data audit trails.
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Dissolution and disintegration testingExecuted with validated SOPs and full raw data audit trails.
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Residual solvent analysis (Class 1, 2, 3)Executed with validated SOPs and full raw data audit trails.
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Heavy metals and elemental impuritiesExecuted with validated SOPs and full raw data audit trails.
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Microbial limit testingExecuted with validated SOPs and full raw data audit trails.
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Physicochemical characterizationExecuted with validated SOPs and full raw data audit trails.
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Finished product release testingExecuted with validated SOPs and full raw data audit trails.
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Stability-indicating method developmentExecuted with validated SOPs and full raw data audit trails.
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Genotoxic impurity testingExecuted 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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HPLC (UV/PDA/FLD)

Assay, related substances, dissolution testing

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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GC-FID / GC-MS

Residual solvents, volatile impurities

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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UV-Vis Spectrophotometer

Identification, assay, dissolution

IQ/OQ/PQ QualifiedALCOA+ Audit Trail
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LCMS/MS

Trace impurity profiling, genotoxic impurities

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.

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Stage 01

Sample Receipt & Login

Samples logged into LIMS with unique ID, condition assessed, and storage assigned.

02
Stage 02

Method Assignment

Validated pharmacopoeial or in-house method assigned by senior scientist.

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Stage 03

Analysis & QC Review

Testing performed in duplicate; results reviewed by QC for accuracy and compliance.

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Stage 04

Report & Dispatch

Comprehensive CoA/test report issued within agreed TAT with raw data backup.

Scientific Questions & Answers

Technical FAQs

Standard testing is delivered in 5–10 working days. Expedited priority slots are available upon request with dedicated instrument reservations and expedited QC review.
Ready for Sample Testing?

Initiate Your Pharmaceutical Testing Study

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

Schedule Scientific Consultation
Cross-Discipline Solutions

Related Analytical Services

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Analytical Method Development & Validation

Stability-indicating, residual solvent, dissolution, and cleaning validation methods per ICH/FDA/USP guidelines.

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Stability Studies

ICH-compliant long-term, accelerated, and stressed stability studies with 24/7 monitored climatic chambers.

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Cleaning Method Validation

Validation that equipment is free from API residues and detergents between production batches, as per FDA cGMP guidelines.

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