IRCLASS Systems and Solutions Pvt Ltd (ISSPL) Lab is NABL accredited laboratory provides testing for a wide range of pharmaceutical products starting from raw materials, excipients, Active Pharmaceutical Ingredients (APIs), bulk drug, intermediates, parenteral preparations, medical devices & surgical items as per Indian and International Pharmacopeia Standards (IP, EP, BP, USP, JP etc.). Quality control is one of the pre-requisites to regulatory compliances for pharmaceutical products. We have 21 CFR part 11 compliance software for data integrity. Laboratory is well equipped with best technologies like HPLC, AAS, GC, ICP-MS, GC-MS, FTIR, UV Spectrophotometer, LC-MS/MS and IC etc

Our comprehensive range of services under testing for drugs & pharmaceutical products include

  • Identification
  • Physicochemical Testing
  • Assay
  • Uniformity of Content
  • Method Validation
  • Particulate Matter
  • Microbiological Analysis
  • Sterility
  • BET
  • Extractable Leachable Analysis

Stability Testing

Stability testing for drugs provides real-time response data of a drug substance or product in the given period under the influence of various environmental factors, such as temperature, humidity and light for long term / intermediate / accelerated storage condition. This data helps to determine & validate the shelf life of pharmaceutical products with respect to its labelled specifications and recommended storage conditions. The drug testing laboratory of ISSPL Lab is well-equipped to conduct stability testing, both real- time and accelerated, as per standards in a wide range of pharmaceutical products. We are performing stability studies as per ICH guidelines (Q1A(R2)) for new drug substances and products.

Extractable and Leachable Studies

Extractable are any element or compounds that can be removed from a packaging compounds or devices, or manufacturing process contact material, into solvents under controlled laboratory conditions. Leachable is an extractable that migrate into a drug product under storage condition. ISSPL can provide customized protocol driven extricable and leachable testing services to ensure that product meets regulatory requirements and compliances

Method Development

We have extensive experience in developing analytical methods using our sophisticated facility for pharmaceutical industries. Some of the applications are

  • Quality control of APIs, starting material, intermediates, finished products, impurities, and degradation products
  • Stability testing
  • Identification and characterization of substances, impurities and degradation products
  • Microbiological contaminants determination

Method Validation

Validation of analytical protocols used in the pharmaceutical industry is critical to ensure that they are suitable, reproducible and ideal for the analysis being carried out. ISSPL Lab’s drug testing laboratory has excelled in performing chemical and microbiological method validations across many industry techniques and product types. We are equipped to assist through the entire process comprising planning, preparation of the protocol, and analytical testing leading to the final project report. The vital areas in which we have expertise include

  • Dissolution profile studies
  • Product formulation Methodologies
  • Stability Testing as per ICH guidelines

Microbiological Studies

Microbial contamination is a significant risk within the pharmaceutical industry, having a potential impact on product integrity and patient safety. Through its well equipped drug testing laboratory, We offers a comprehensive range of microbiological testing services compliant with GMP (Good Manufacturing Practices) requirements for pharmaceutical products, which include

  1. Sterility Tests
  2. Bacterial Endotoxin Tests (BET)
  3. Efficacy Tests
  4. Microbiological Assays in Antibiotics

Physicochemical Testing

Physicochemical testing is vital for verifying the quality of manufactured pharmaceutical products before a lot releases into the market. Under physical & chemical parameters, a drug should comply with the specifications mentioned in the latest pharmacopoeia determining its stability, solubility and in-vivo delivery. ISSPL Lab drug testing laboratory is continuously delivering its best analytical services to meet manufacturing and quality standards. Some of the tests we perform under physicochemical testing are

  • Appearance
  • pH
  • Moisture
  • Content
  • Osmolality
  • Viscosity
  • Optical activity
  • Spectral analysis

Related Substance/ Impurity Testing

The identification of pharmaceutical-related substance or impurity is an essential analytical activity in the drug development process. Pharmaceutical impurities can arise from different sources and significantly damage the purity, stability and safety of drug substances or finished drug products. These impurities/ related substances are generally present at very low levels. Consequently, sensitive and specific assay methods are required to quantify them and collate relevant information and facilitate efficient drug manufacturing processes. ISSPL drug testing laboratory proposes strategies for identifying such impurities/ related substances using sophisticated instruments such as:

  • LC-MS
  • GC-MS
  • HPLC
  • AAS
  • ICP-MS

We test all product categories, including API & raw materials, and finished products.

  1. Tablets
  2. Capsules
  3. Injections- Large Volume Parental & Small Volume Parental
  4. Syrup
  5. Suspension
  6. Eye Drops
  7. Ear Drops
  8. Ointment

Surgical Items

  1. Catheters
  2. Urine Bag
  3. Gloves
  4. Masks
  5. Bandage/Gauge
  6. Needle
  7. Sutures
  8. Adhesive Tape
  9. Sanitary Napkin
  10. IV Set
  11. Cannula
  12. BT (Blood Transfusion) Set