Pharma
🧬

Pharmaceutical Testing

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

USPICHAPI TestingFormulations
Overview

About This Service

AnalytiLab 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.

ICH Q2(R1)USPEPBPIPFDA Guidelines

Key Information

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

Accredited by

NABLISO 17025USFDA
Scope of Work

What's Included

API identification and characterization
Assay and related substances by HPLC
Dissolution and disintegration testing
Residual solvent analysis (Class 1, 2, 3)
Heavy metals and elemental impurities
Microbial limit testing
Physicochemical characterization
Finished product release testing
Stability-indicating method development
Genotoxic impurity testing
Equipment

Instruments Used

HPLC (UV/PDA/FLD)

Assay, related substances, dissolution testing

GC-FID / GC-MS

Residual solvents, volatile impurities

UV-Vis Spectrophotometer

Identification, assay, dissolution

LCMS/MS

Trace impurity profiling, genotoxic impurities

Compliance

Regulatory Standards

ICH Q2(R1)
USP
EP
BP
IP
FDA Guidelines
Our Process

How We Work

01

Sample Receipt & Login

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

02

Method Assignment

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

03

Analysis & QC Review

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

04

Report & Dispatch

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

Get Started

Ready to Start Your Pharmaceutical Testing?

Our scientific team is ready to assist. Submit your sample or request a quote today.