Precision Analytical Testing for Regulated Industries
HPLC · UHPLC · LC-MS/MS · GC-MS · Impurity Analysis · Stability Testing. Audit-ready reports, validated methods, and fast turnaround for pharmaceutical, biotech, food, and research organisations worldwide.
Why Analytical Testing Projects Stall
Technical procurement and R&D teams across pharma, biotech and food manufacturing face the same critical blockers. HIPSOUL is built to eliminate them.
Regulatory Risk from Unvalidated Methods
Non-validated or poorly documented analytical methods create submission failures, audit findings, and costly batch rejections in regulated submissions.
Unacceptable Lab Turnaround Times
Overloaded contract labs push timelines to 4–6 weeks, stalling formulation programmes, regulatory submissions, and product launches.
Inconsistent Data You Cannot Defend
Variability between analysts, instruments, and lab sites produces results that fail reproducibility checks and cannot withstand regulatory scrutiny.
Managing Too Many Fragmented Vendors
Separate vendors for HPLC, mass spec, stability, and impurities creates coordination overhead, data handoff errors, and accountability gaps.
Confidentiality Gaps with CROs
Novel formulations, proprietary APIs, and unreleased drug candidates require rigorous confidentiality controls many contract labs fail to provide.
No Validated Method for Your Compound
Novel molecules, complex matrices, or low-level impurity detection often require custom method development — a capability many testing-only labs lack.
Analytical Techniques & Methods
From routine HPLC assay to complex LC-MS/MS impurity profiling, our capabilities span the full analytical spectrum — all under one validated quality system.
HPLC Analysis
Reversed-phase, normal-phase, and ion-exchange HPLC for assay, purity, and related substances with UV/DAD/RI/fluorescence detection.
UHPLC Analysis
Sub-2-micron particle columns with high-throughput gradients for faster run times, higher resolution separation, and reduced solvent consumption.
LC-MS/MS Analysis
Triple-quadrupole and high-resolution mass spectrometry for trace-level quantification, structure elucidation, and genotoxic impurity profiling at ppm/ppb levels.
GC-MS Analysis
Gas chromatography-mass spectrometry for residual solvent analysis (ICH Q3C), volatile impurities, flavour profiling, and extractables/leachables screening.
Impurity Analysis
Comprehensive impurity profiling for APIs and finished products — related substances, degradation products, genotoxic impurities, and elemental impurities per ICH Q3A/B/D.
Stability Testing
ICH Q1A-compliant long-term, accelerated, and stress stability studies with stability-indicating methods, scheduled timepoints, and complete data packages.
From First Contact to Final Report
A transparent, defined process eliminates ambiguity and gives you complete visibility at every stage of your analytical project.
Project Consultation
We discuss your compound, matrix, regulatory context, and testing requirements. NDA signed before any technical disclosure.
Scope & Quotation
Detailed technical scope, method selection, timeline, and fixed-price quotation provided within 24–48 hours of initial consultation.
Sample Receipt & Intake
Samples logged, inspected, and assigned a unique project ID on arrival. Chain-of-custody documentation maintained throughout.
Analysis & QC Review
Testing performed against validated or agreed methods. Independent QC review of all raw data and calculations before any result is finalised.
Report Delivery
Signed analytical report with full raw data, chromatograms, calculations, and method references delivered securely via encrypted transfer.
Instruments Built for Regulatory-Grade Work
Our analytical laboratory is equipped with a modern fleet of chromatography and mass spectrometry instruments operating under full IQ/OQ/PQ qualification with scheduled maintenance and calibration.
- Waters ACQUITY UPLC & Agilent 1260/1290 HPLC Systems
- Triple Quadrupole LC-MS/MS (ESI/APCI) for Trace Analysis
- GC-MS/FID for Residual Solvents & Volatile Impurities
- Validated Stability Chambers (ICH Zones I–IV)
- Fully Qualified IQ/OQ/PQ Instrument Fleet
- 21 CFR Part 11-Compliant Data Management (Empower / OpenLAB)
Industries We Serve
Analytical testing expertise tailored to the regulatory requirements and technical challenges of each sector.
Analytical Testing in Action
Real projects, measurable outcomes. Our clients' results speak to the quality and reliability of HIPSOUL's analytical programme.
Pharmaceutical
Nitrosamine Impurity Quantification for NDA Submission
A US-based pharma company required nitrosamine testing across 6 drug products for FDA submission under the accelerated safety review programme. LC-MS/MS method developed and validated within 3 weeks.
Food & Beverage
Mycotoxin Profiling in Multi-Grain Food Matrix
A European food manufacturer required simultaneous mycotoxin quantification across 8 analytes in a complex grain matrix. LC-MS/MS multi-residue method achieved detection at 0.5 ppb with full EU regulation compliance.
Biotechnology
12-Month Accelerated Stability Study for Novel Peptide API
A biotech start-up needed ICH Q1A stability data to support IND filing. HIPSOUL developed stability-indicating UHPLC method, established ICH chambers, and delivered 6-month real-time and accelerated data packages on schedule.
Frequently Asked Questions
Answers to the questions technical buyers ask most before starting a HIPSOUL analytical testing project.
What analytical testing techniques does HIPSOUL support?
HIPSOUL provides HPLC, UHPLC, LC-MS/MS, GC-MS, quantitative and qualitative analysis, impurity profiling, residual solvent testing, and stability testing. We support both pharmacopoeial and custom methods across all major chromatography platforms.
Are your analytical testing services GMP compliant?
Yes. Our analytical testing laboratory operates under GMP-aligned quality standards with full traceability, validated methods, and audit-ready documentation for regulated industries including pharmaceutical and biotech. All instruments are qualified and all data is managed in compliance with 21 CFR Part 11 principles.
What sample types and volumes do you accept?
We accept APIs, formulated products, raw materials, excipients, food matrices, nutraceuticals, and cosmetic samples. Typical submissions range from 50mg to multi-gram quantities. Exact requirements are confirmed at project scoping; we can advise on minimum sample amounts for your testing scope.
What is your typical turnaround time for analytical testing?
Standard turnaround is 5–10 working days from sample receipt and project confirmation. Expedited 2–3 day turnaround is available for urgent regulatory or quality-release projects. Final timelines are confirmed in your project quotation based on scope and current laboratory capacity.
Do you sign NDAs and protect confidential formulations?
Yes. We routinely sign mutual NDAs before any project discussion or technical disclosure. All sample data, formulations, analytical results, and project details are held in strict confidence and never shared with third parties under any circumstances.
Do you accept samples from outside India and ship internationally?
Yes. We accept samples from the USA, Europe, Australia, the Middle East, and globally. We provide guidance on import/export documentation requirements for APIs, controlled substances, and regulated materials, and work with established logistics partners for safe international shipment.
Can you develop a new analytical method if we do not have one?
Yes. Method development and validation are core HIPSOUL capabilities. We can develop, optimise, and validate stability-indicating or application-specific methods before commencing routine testing. This is a single-source engagement — no separate vendor required for methods and analysis.
Still have questions about your specific project?
Talk to an ExpertRequest a Quote for Your Analytical Testing Project
No-obligation quote delivered within 24–48 hours. NDA signed before any technical discussion. Serving pharmaceutical, biotech, food, and research clients in the USA, Europe, India, Australia, and the Middle East.
Strict confidentiality & NDA on all projects · GMP-aligned documentation · Quote within 24–48 hours
