ICH Q3A/B & Compendial

Chromatographic Purity, Assay & Related Substances by HPLC

Determining active potency and identifying organic impurities (process-related degradation products and synthetic intermediates) is foundational to pharmaceutical quality. Our laboratory evaluates chromatographic purity, peak symmetry, theoretical plates, tailing factors, and resolution conforming strictly to official pharmacopoeias (IP, BP, USP, EP, JP).

Standard Turnaround
3 - 5 business days
Testing Facility
8,500 sq. ft. cGLP Lab, Vapi
Data Integrity
21 CFR Part 11 Compliant
Regulatory Overview & Key Technical Definition

About Related Substances & Assay (HPLC)

Satvam Research provides high-resolution chromatographic assay and related substances determination for Active Pharmaceutical Ingredients (APIs), key starting materials, and finished formulations. Operating Shimadzu Prominence LC-2080C systems with UV-Vis, Photodiode Array (PDA), and Refractive Index (RID) detectors under 21 CFR Part 11 software control, we identify and quantify known and unknown organic impurities at trace levels.

Testing Scope

Key Capabilities & Parameters

Conducted strictly in accordance with official compendial monographs and validated study protocols

Finished dosage form assay (tablets, capsules, syrups, topicals, injectables)
Related substances and chromatographic purity profiling
Impurity peak identification via PDA spectral library matching
Chiral HPLC separations for optical isomers and enantiomeric purity
System suitability parameters: resolution, tailing, repeatability (%RSD < 1.0%)
Infrastructure

Qualified Instrumentation Deployed

21 CFR Part 11 compliant hardware configurations governed by full IQ/OQ/PQ qualifications

HPLC Systems with PDA/UV/RID - Prominence LC-2080C
Shimadzu Corporation
Model: Prominence LC-2080C

HPLC Systems with PDA/UV/RID

Multi-wavelength spectral identification, purity angle computation, and low-drift quantitation.

Compliance Architecture

Regulatory Framework & Standards

Testing protocols aligned with domestic and global health authority requirements

ICH Q3A(R2) Impurities in New Drug Substances
ICH Q3B(R2) Impurities in New Drug Products
USP <621> Chromatography
Ph. Eur. 2.2.46 Chromatographic Separation Techniques
Logistics

Sample Submission Guidelines

Dispatch specifications for guaranteed analytical integrity

Minimum Sample Qty
25 - 50 g of bulk active or 60 units of finished drug product.
Container Type
Amber glass bottles or moisture-proof blister packs.
Storage Condition
Stored according to labeled conditions (ambient, 2-8°C, or protected from light).
Standard TAT
3 - 5 business days
Special Instruction: Provide reference standards / working standards with CoA where applicable.
Frequently Asked Questions

Technical & Regulatory Inquiries

Can Satvam Research test with Refractive Index (RID) detection?

Yes. Our Shimadzu HPLC workstations include RID detectors specifically calibrated for compounds lacking chromophores, such as sugars, glycols, polymers, and excipients.

Initiate Your Related Substances & Assay (HPLC) Testing

Contact our analytical laboratory in Vapi to review your protocol requirements, discuss sample shipping, or schedule a facility audit.

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