ABOUT LABORATORY
The IPRF Public Testing Laboratory (PTL) is a state-of-the-art pharmaceutical testing facility designed to deliver accurate, reliable, and regulatory-compliant analytical services. Equipped with advanced analytical instruments, 21 CFR Part 11-compliant systems, and a Laboratory Information Management System (LIMS), the laboratory ensures precision, traceability, and data integrity in every test performed. It provides comprehensive pharmaceutical testing, including chemical analysis, microbiological testing, instrumentation analysis, and stability studies. The laboratory follows stringent quality standards and validated testing procedures to ensure consistent and dependable results. With a strong focus on scientific excellence, regulatory compliance, and customer confidence, IPRF PTL supports pharmaceutical manufacturers, researchers, and healthcare organizations with trusted analytical solutions. The laboratory follows stringent quality standards and validated testing procedures to ensure consistent and dependable results. With a strong focus on scientific excellence and regulatory compliance, IPRF PTL delivers trusted analytical solutions.

NABL ACCREDIATION
The IPRF Public Testing Laboratory (PTL) is a state-of-the-art pharmaceutical testing facility designed to deliver accurate, reliable, and regulatory-compliant analytical services. Equipped with advanced analytical instruments, 21 CFR Part 11-compliant systems, and a Laboratory Information Management System (LIMS), the laboratory ensures precision, traceability, and data integrity in every test performed.
TESTING SERVICES

Chemical Testing
Ensuring purity, potency, identity, and quality through precise chemical analysis.

Microbiological Testing
Ensuring microbial safety, purity, and quality through reliable microbiological analysis.

Water Testing
Ensuring water purity, safety, and compliance through accurate quality testing.

Raw Material Testing
Ensuring identity, purity, potency, and quality of pharmaceutical raw materials.

Finished Product Testing
Ensuring quality, safety, potency, and compliance of finished pharmaceutical products.

Stability Testing
Assessing product stability, shelf life, and quality under defined storage conditions.
LABORATORY EQUIPMENTS

Liquid Chromatography - Mass Spectrometry
LC-MS (Agilent) offers detection, isolation and purification of drug metabolites, characterization of components, Glycan analysis, Water analysis.

Inductively coupled plasma mass spectroscopy
ICP-MS (Agilent) is used to detect metals and several non-metals at concentrations as low as parts per trillion on non-interfered low-background. In the pharmaceutical industry.

High-performance liquid chromatography
IPRF employs a various H.P.L.C. System with autosampler, DAD and VWD detector to evaluate the quality of formulated products, impurity profile and active pharmaceutical ingredients.

Gas Chromatography
GC used to estimate the purity or content of the substance, which have properties of vaporization at higher temperature. Residual solvents of all classes are tested as per their limit by head space analyzer.

Fourier Transform Infrared Spectroscopy
FTIR is mainly used for identification of Functional Group. The most common use is in the identification of unknown materials and confirmation of production materials (incoming or outgoing).

Digital Polarimeter
ATAGO's Polarimeter measures the optical rotation of optically active substances such as saccharide, ascorbic acid, sodium glutamate and others. It is also used for measuring specific rotation, concentration & international sugar scale of optically active substances.

Dissolution Test
Dissolution tester is designed to determine compliance with the dissolution requirements for solid dosage forms administered orally. The test is intended for tablets and capsules.

Dissolution Test
The V-730 UV-visible spectrophotometer is designed to be simple to use with precise results with 1nm spectral bandwidth for high resolution and a linear dynamic range to over 3AU across the entire spectrum.

Lablink Xtra Pure Water System
Lablink XtraPure Water System provides reliable and compact system which produces UltraPure Water System. Xtra Pure System is equipped with reverse osmosis (RO) and additional filtration system to produce deionized water.

SHIMADZU TOC
Shimadzu is one of the world's leading manufacturers of total organic carbon (TOC) analysers. TOC analysers boast a high level of detection sensitivity, making it suitable for a variety of applications for the pharmaceutical testing.

Potentiometer/KF Apparatus
Potentiometric titrator is used to determine the purity of a substance as per standard method. It is useful in clinical chemistry fo the analysis of metals, cyamide, ammonia etc. in water or waste water. It determines water contents in difficult substances.

Disintegration Test Apparatus
Disintegration tester is mainly used for tablet and capsules, the first important step that capsules /tablets breaks into smaller particles or granules that disintegration within described time when placed in a liquid.

Laminar Air Flow
Provides a controlled aseptic environment for Microbial Limit and Microbiological Assay testing, helping minimize contamination.

Biosafety Cabinet
Provides a protected, contamination-controlled environment for Sterility Testing, ensuring safe and accurate microbiological analysis.

Incubator
Maintains controlled temperature conditions required for microbial growth, supporting accurate Bioburden and microbiological testing.

LAL Testing System
Enables sensitive detection and quantification of bacterial endotoxins in pharmaceutical products for reliable endotoxin analysis.

Stability Chamber
IPRF provides dedicated 3000 L capacity stability chambers designed for comprehensive stability studies of drug substances and drug products in accordance with ICH guidelines. These facilities support systematic evaluation of product quality and stability under controlled environmental conditions throughout the defined study period. The stability chambers are equipped to maintain precise temperature and relative humidity conditions required for different stability protocols, including long-term, intermediate, and accelerated studies. The controlled conditions help evaluate changes in product quality, potency, physical characteristics, and other critical parameters over time. The chambers feature advanced control and monitoring systems for consistent environmental conditions and continuous data recording. With dedicated infrastructure, automated monitoring, and controlled storage conditions, IPRF supports the generation of accurate, reliable, and traceable stability data for pharmaceutical products.
TESTING PROCESS
Frequently Asked Questions
What types of pharmaceutical samples does PTL test?
We test raw materials, finished products, packaging materials, water, and other all types of pharmaceutical samples. Yes, PTL is NABL accredited for its approved scope of testing.
Is PTL NABL accredited?
Yes, PTL is NABL accredited for its approved scope of testing.
What testing services does PTL offer?
We offer chemical, instrumental, microbiological, sterility, stability, and other pharmaceu cal tes ng services.
How can I submit my sample for testing?
You can send your samples to either of our loca tions:
Corporate Office: 803, Kumar Surbhi, Pune-Satara Road, Swargate, Pune – 411009.
Factory: G-32, MIDC, Jejuri, Dist. Pune – 412303. You may send the sample to whichever loca on is more convenient for you.
What documents are required for sample submission?
The required documents may include the Sample Intimation Form, Standard Operating Procedure (SOP), Method of Analysis, applicable Pharmacopoeial Standard (IP/BP/USP), Specifications, and other relevant testing documents, as applicable.
What is the turnaround time for testing?
The standard turnaround me is 3 to 5 working days, depending on the type of test and sample requirements.
Can PTL provide a Certificate of Analysis (COA)?
Yes, COA/test reports can be provided as applicable.
Does PTL provide microbiological and sterility testing?
Yes, we provide microbiological and sterility tes ng facili es.
How can I request a quotation for my testing requirements?
Share your sample and testing requirements with us to receive a quotation.
How can I contact PTL for any testing-related query?
You can contact our team through the Contact Us sec on on our website or email us at am.qc@iiprf.com or qchead@iiprf.com