Pharmaceuticals Sector includes vast basket of products from generic to brand medications and medical devices. These industries discover, develop and produce various pharmaceutical drugs for use as medications to be administered to patients with the aim to cure them, vaccinate them.

Pharmaceutical products also known as medicines or drugs are essential for prevention & treatment of diseases and protection of Public health.

The use of ineffective, poor quality harmful medicines can lead to many cause and effect in the society at large. It may also undermine confidence in the health system, health professionals, pharmaceuticals manufacturers and distributors.

Ensuring regular access to good quality, safe and affordable medicines is still a challenge for many countries. The WHO Regional Office provides relevant expertise and technical assistance for the area of quality assurance, regulation and legislation for safety & efficacy of medicines.

Antibiotics, Vaccines, Human blood plasma fractions, Steroid hormones, Vitamins etc. are some of the examples of Pharmaceuticals products. Tablets, Capsules, Injections, Syrup, Drops and Ointments are some of the forms of widely used Pharmaceuticals products.

Need and Importance of Pharmaceuticals Product Testing

The quality control is the one of the most important part in the entire pharmaceutical production and control process.

We at Chromak Research have well-equipped and state of the art Laboratory which perform all the test needed to check the identification, quality, purity and safety of the product according to the various established standard protocols (USP, FCC, EN, BP, JP, OECD, ASTM etc.) as well as client demands.

These test includes

  • Testing of Raw Material, API, Excipients and Finished Products
  • Stability Testing
  • Suitability Testing
  • Water Testing
  • Sterility Test
  • Impurity testing (Heavy Metal, Residual Solvents, Contamination)
  • Total Organic Carbon (TOC)
  • Antimicrobial Effectiveness Test
  • Method Development
  • Method Validation and transfer

Our Analytical Instruments Lab includes

  • HPLC systems (with UV/Vis, Diode Array, IR, FTIR, Fluorescence & ELSD detectors)
  • ICPMS with Microwave digestion system
  • GC systems with FID & TCD detectors & Head Space injection
  • LC-MS/MS
  • GC-MS/MS with Head Space injection
  • Spectrophotometers
  • Dissolution systems

Our testing methods includes

  • USP 1663 &1664 Extractables & Leachables studies
  • Impurity Identification in complex formulation
  • USP 661.1, 661.2 & 671 testing for CCS
  • USP 232 & 233 Elemental Impurities by ICPMS
  • USP/NF Monograph testing for Pharmaceuticals Active & Inactive Raw materials.
  • 21 CFR 176 (Indirect Food Additives)
  • Amino acid analysis (Peak X detection in 5-Hydroxy-L-Tryptophen (5-HTP) as per FDA methodology)
  • Enzyme Activity Assay
  • Cleaning Validation