HPLC and UPLC Pharmaceutical Testing Services | NABL Accredited | Auriga Research
High Performance Liquid Chromatography (HPLC) and Ultra Performance Liquid Chromatography (UPLC) are the cornerstone analytical techniques in pharmaceutical quality control and development. Auriga Research operates the largest HPLC fleet across any NABL-accredited pharmaceutical CRO in India — 110+ HPLC and UPLC systems across all 5 labs, with UPLC platforms deployed at Baddi and Manesar (USFDA Inspected). The fleet supports reverse-phase, normal-phase, ion-exchange, size-exclusion, and chiral separations with UV-Vis, PDA, RI, and fluorescence detection across the full pharmaceutical analytical workflow.
605 chromatography columns are kept in active stock across the lab network — eliminating sourcing delays during method development and enabling rapid column-screening iteration. Routine pharmacopoeial testing — assay, related substances, dissolution per USP 711, content uniformity per USP 905 — runs in parallel with specialised applications including chiral separation, size-exclusion chromatography (SEC), forced degradation, and cleaning validation. Each analysis follows validated, stability-indicating methods with full system-suitability verification per USP 621.
For clients requiring new analytical methods, the team provides end-to-end method development and validation per ICH Q2(R2) (Validation of Analytical Procedures, March 2024) and ICH Q14 (Analytical Procedure Development, 2023) — the current active framework. Method development and validation is anchored at Manesar (Plot 136, Sector 5, IMT Manesar), the USFDA Inspected facility, with method transfer to Delhi, Bangalore, Baddi, or Bahadurgarh as required for production-scale routine testing. NABL-accredited (ISO/IEC 17025:2017) reports are accepted by CDSCO, USFDA, EMA, and PMDA submissions without re-testing.
110+ HPLC Systems · 605 Columns in Stock · UPLC at Baddi & Manesar
The largest HPLC fleet across any NABL-accredited pharmaceutical CRO in India. 110+ HPLC and UPLC systems distributed across all 5 labs — Delhi, Manesar (USFDA Inspected), Bahadurgarh, Baddi, and Bangalore (USFDA Inspected). UPLC at Baddi and Manesar for sub-2-micron high-resolution work. 605 chromatography columns in active stock — no sourcing delays for method development.
Six HPLC and UPLC Testing Services
Each card maps the service to the analytical method, the governing regulatory or pharmacopoeial reference, and the Auriga lab where it is performed.
Assay and Related Substances by HPLC
Quantitative assay and related substances / impurity profiling for APIs and finished products per USP, IP, BP, and EP monographs and ICH Q3A / Q3B thresholds. Routine testing at all 5 labs.
Method Development and Validation
HPLC and UPLC method development and ICH Q2(R2) validation, with Q14 lifecycle framing. 605 columns in stock for rapid iteration. Anchored at Manesar (USFDA Inspected).
Dissolution Testing by HPLC
Dissolution sample quantification by HPLC across all dosage forms — immediate, modified, and extended release — per USP 711 dissolution and the relevant pharmacopoeial monograph.
Chiral Separation & Enantiomeric Purity
Chiral HPLC for enantiomeric purity determination and chiral impurity quantification using polysaccharide-based and protein-based chiral stationary phases.
Size-Exclusion Chromatography (SEC)
SEC for molecular-weight distribution of biologics, peptides, proteins, and synthetic polymers. UV, RI, and light-scattering detection options.
Cleaning Validation Residue Analysis
Swab and rinse sample analysis by HPLC for cleaning validation across shared-equipment manufacturing. Sub-ppm LOQ for residue carry-over studies.
Project Timelines
Indicative TAT from sample receipt. Confirm exact timeline with your SPOC at quote stage based on lab, method status, and sample queue. *Express testing on established methods available subject to confirmation.
| Service Type | Turnaround Time |
|---|---|
| Standard HPLC Testing (assay, RS, dissolution, CU) | 5 to 7 business days |
| Rush HPLC Testing | 2 to 3 business days |
| Express Testing (established methods) | 2 to 3 working days* (confirm at quote) |
| Method Development (HPLC / UPLC) | 3 to 4 weeks |
| Method Validation per ICH Q2(R2) | 4 to 6 weeks |
| Full Method Development + Validation Package | 4 to 6 weeks (Manesar) |
How It Works
Get a Quote
Share your analyte, matrix, pharmacopoeial specification, and regulatory purpose. Your SPOC confirms the appropriate lab, instrument variant (HPLC or UPLC), and TAT including express options.
Collect and Send Your Sample
Prepare sample per SPOC instructions at quote stage. Each sample is bar coded and registered in YLIMS on receipt.
Testing and QA Review
Your sample is tested under NABL-accredited conditions. Results pass through formal QA review including instrument log check, reference standard verification, and analyst sign-off.
Receive Your NABL Report
Your NABL-accredited report is delivered digitally within the committed TAT, formatted for CDSCO, USFDA, and regulatory submission. Track status via YLIMS.
Who Needs HPLC and UPLC Testing
- Pharma QC teams conducting routine release testing of APIs and finished products against pharmacopoeial monographs.
- Generic developers requiring method development and validation for ANDA or CDSCO dossier submission.
- Stability teams requiring HPLC as the core method in ICH Q1A(R2) accelerated and long-term stability studies.
- CDMO clients needing HPLC method transfer as part of formulation handover and scale-up.
- Biopharma teams requiring SEC for molecular-weight distribution of biologics, peptides, and synthetic polymers.
- Regulatory affairs teams compiling Module 3 analytical method dossier sections per ICH Q2(R2) and Q14.
- API manufacturers requiring chiral HPLC for enantiomeric purity in single-enantiomer molecule programmes.
- QC and validation teams running cleaning validation residue analysis across shared-equipment manufacturing lines.
Why Auriga for HPLC and UPLC Testing
110+ HPLC and UPLC Systems Across All 5 Labs
The largest HPLC fleet across any NABL-accredited pharmaceutical CRO in India. No queue delay even for high-volume routine release testing and stability programmes. UPLC at Baddi and Manesar (USFDA Inspected).
605 Chromatography Columns in Stock
Active column inventory across the lab network eliminates sourcing delays during method development — rapid column-screening iteration and method transfer without procurement bottlenecks.
USFDA Inspected at Manesar and Bangalore
HPLC and UPLC data generated at Manesar and Bangalore — both USFDA Inspected facilities — accepted in USFDA dossier submissions without re-testing.
ICH Q2(R2) + Q14 Method Development & Validation
Current-framework method development and validation per ICH Q2(R2) (March 2024) and ICH Q14 (2023). Method documentation built for direct Module 3 inclusion.
Chiral, SEC, Cleaning Validation All In-House
Beyond routine assay and RS: chiral separation, SEC for biologics, and cleaning validation residue analysis — all under one accredited NABL scope. One vendor, one consolidated report.
Express Testing in 2 to 3 Working Days
Express HPLC testing on established methods available in 2 to 3 working days for time-critical batch release. Confirm scope and TAT with your SPOC at quote stage.
110+
HPLC & UPLC Systems
5 Cities
Delhi · Manesar · Bahadurgarh · Baddi · Bangalore
12,000+
Clients Served
1985
Arbro Group · Auriga Research
Regulatory References
- • ICH Q2(R2) — Validation of Analytical Procedures (March 2024). Current active framework.
- • ICH Q14 — Analytical Procedure Development (2023). Companion to Q2(R2).
- • ICH Q3A / Q3B — Impurity thresholds for new drug substances and new drug products.
- • USP <711> — Dissolution.
- • USP <905> — Uniformity of Dosage Units.
- • USP <621> — Chromatography (general chapter).
- • IP, BP, EP, JP — Pharmacopoeial monographs for assay, related substances, and identification.