cGLP • 21 CFR Part 11 Compliant

Pharmaceutical & Formulation Testing

Comprehensive Defensible Analytical Testing for APIs, Excipients & Finished Formulations

In the tightly regulated pharmaceutical sector, analytical data must endure rigorous regulatory scrutiny from global health authorities including US FDA, EDQM, MHRA, WHO, CDSCO, and state FDAs. Satvam Research operates fully qualified Shimadzu HPLC Prominence-i (with PDA), Brevis GC-2050 (Headspace HS-20 NX), LabIndia ICP-5000DV Dual-View ICP-OES, and Malvern Mastersizer 3000 particle size analyzer to deliver uncompromised analytical precision.

Standard Turnaround
5 to 7 Business Days
Testing Facility
8,500 sq. ft. cGLP Lab, Vapi
Data Integrity
21 CFR Part 11 Compliant
Regulatory Overview & Key Technical Definition

About Pharmaceutical Testing

Satvam Research delivers cGLP and 21 CFR Part 11 compliant analytical testing for pharmaceutical manufacturers across Gujarat, Maharashtra, and pan-India. Operating an 8,500 sq. ft. laboratory on NH-48 in Vapi, our pharmaceutical testing covers Active Pharmaceutical Ingredients (APIs), excipients, pellets, tablets, capsules, injectables, and medical devices strictly per IP, BP, USP, EP, JP, and ICH guidelines.

Full Analytical Scope

Testing Parameters & Methodologies

Conducted in strict compliance with official national and international monographs

Assay, Purity & Related Substances

Chromatographic quantification of active ingredients, known impurities, and degradation products.

HPLC Assay with Photo Diode Array (PDA) detection
Related substances & degradation products quantification
Chiral chromatography for enantiomeric purity
Potency determination against USP/EP reference standards
Uniformity of dosage units (Content Uniformity)

Residual Solvents & Volatile Impurities

Static Headspace Gas Chromatography per ICH Q3C / USP <467>.

Class 1 carcinogenic solvents (Benzene, Carbon tetrachloride, 1,2-Dichloroethane)
Class 2 limited solvents (Methanol, Acetonitrile, Toluene, Hexane, DMF, DMSO)
Class 3 low-toxicity solvents (Acetone, Ethanol, Ethyl Acetate, IPA)
Custom headspace temperature and equilibration profiling

Trace Elemental Impurities (ICH Q3D)

Closed-vessel microwave digestion and Dual-View plasma spectroscopy.

Class 1 toxic heavy metals: Lead (Pb), Cadmium (Cd), Arsenic (As), Mercury (Hg)
Class 2A elements: Cobalt (Co), Nickel (Ni), Vanadium (V)
Class 2B & 3 elements: Thallium, Gold, Palladium, Iridium, Osmium, Rhodium, Ruthenium, Selenium, Silver
Screening against established Permitted Daily Exposures (PDE)

In-Vitro Dissolution & Physical Release

Dosage form dissolution kinetics and compendial physical testing.

Multi-point dissolution profiling (USP Apparatus 1 Basket & Apparatus 2 Paddle)
f1 (Difference) & f2 (Similarity) factor mathematical comparison
Disintegration testing (USP <701>) with automated end-point sensing
Friability (USP <1216>), tablet hardness, thickness, and dimension profiling
Particle size distribution (PSD) by laser diffraction (Malvern Mastersizer 3000)

Stability & Shelf-Life Studies

Walk-in stability storage under continuous 24/7 digital monitoring.

Accelerated testing: 40°C ± 2°C / 75% RH ± 5% RH
Intermediate testing: 30°C ± 2°C / 65% RH ± 5% RH
Long-term climatic testing: Zone I, II, III, IVa, and IVb (30°C / 75% RH)
Photostability testing per ICH Q1B (Option 2 light source)
Analytical Hardware

Qualified Instrumentation Deployed

Governed under 21 CFR Part 11 computerized compliance and complete IQ/OQ/PQ records

High-Performance Liquid Chromatograph - Prominence-i LC-2080C 3D
Shimadzu Corporation, Japan
Model: Prominence-i LC-2080C 3D

High-Performance Liquid Chromatograph

Automated assay, related substances, and method validation with PDA detection and 21 CFR Part 11 software.

Gas Chromatograph with Headspace - Brevis GC-2050 + HS-20 NX
Shimadzu Corporation, Japan
Model: Brevis GC-2050 + HS-20 NX

Gas Chromatograph with Headspace

ICH Q3C Class 1, 2, and 3 residual solvents quantification with high thermal inertness.

Dual-View ICP-OES Spectrometer - ICP-5000DV
LabIndia Analytical
Model: ICP-5000DV

Dual-View ICP-OES Spectrometer

Multi-element simultaneous sub-ppb elemental impurities detection per ICH Q3D.

Laser Diffraction Particle Size Analyzer - Mastersizer 3000
Malvern Panalytical, UK
Model: Mastersizer 3000

Laser Diffraction Particle Size Analyzer

Wet and dry dispersion measurement from 10 nm to 3.5 mm for active powders and suspensions.

Compliance Architecture

Regulatory Standards & Compendia

Authorized procedures matching national and international testing guidelines

Indian Pharmacopoeia (IP)
United States Pharmacopeia (USP <621>, <232>, <467>, <711>)
British Pharmacopoeia (BP) & European Pharmacopoeia (EP)
Japanese Pharmacopoeia (JP)
ICH Q1A/B (Stability), Q2(R1) (Method Validation), Q3A/B/C/D (Impurities)
21 CFR Part 11 Data Integrity
Logistics & Protocols

Sample Submission Guidelines

Dispatch criteria ensuring analytical integrity upon receipt at Vapi lab

Minimum Sample Qty
Finished formulations: 60-100 dosage units; Raw materials/APIs: 25-50 g per test panel.
Container Type
Airtight pharmaceutical-grade amber glass vials or HDPE containers with tamper-evident seals.
Storage Condition
Controlled room temperature (20-25°C) or cold chain (2-8°C / -20°C) with data loggers.
Standard Turnaround
5 to 7 Business Days
Special Instruction: Attach MSDS, batch Certificate of Analysis (CoA), and specific testing monograph requirements.
Frequently Asked Questions

Technical & Regulatory Inquiries

Does Satvam Research comply with 21 CFR Part 11 for pharmaceutical testing?

Yes. All chromatographic workstations (HPLC, GC) utilize Shimadzu LabSolutions DB/CS with centralized multi-tiered privilege matrices, non-editable electronic audit trails, automated password expiration, and secure local server backup.

Can Satvam Research support US FDA and EU GMP regulatory audit data submissions?

Absolutely. Our standard operating procedures, documentation integrity, analytical method transfer protocols, and instrument qualifications (IQ/OQ/PQ) are structured to withstand rigorous scrutiny during regulatory audits.

What is the typical turnaround time for an API compendial release testing panel?

Standard turnaround time is 5 to 7 business days from receipt of samples and reference standards. Rush expedited service is available in 48 to 72 hours.

Initiate Your Pharmaceutical Testing

Contact our laboratory in Vapi to review testing protocol requirements, discuss sample collection, or request priority processing.

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