Particle Count as Per FDA Guideline in Injectable & Eye Drop

Particulate matter consists of mobile, randomly sourced, extraneous substances, other than gas bubbles, that cannot be quantitated by chemical analysis because of the small amount of material they represent and because of their heterogeneous composition. Certain pharmaceutical products must be sterile such as injections, ophthalmic preparations, irrigations solutions, haemodialysis solutions.
Ophthalmic solutions & Injectibles should be essentially free from Particulate Matter due to their indispensible role in health care industry.

Spectro services for Testing & Evaluation of Ophthalmic Solutions Involves:-

  • Light obscuration particle count test
  • Microscopic particle count test

XRD Studies for Crystallization Data:-

X-ray diffraction (XRD) is a key technique to characterize the composition of Drugs & cosmetics. X-ray powder diffraction finds its application in detection & quantification of crystallographic changes, structural characteristics, polymorphic contamination in order to control & improve the quality of Active Pharma Ingredients, raw materials and finished products, excipients. XRD is used for solid-state drug analysis, the result of which provides the analyst with useful information related to drug development, process control, testing and production. Spectro provides a range of testing services for Pharmaceutical & Cosmetics testing using XRD

SEM for Powder:-

Scanning Electron Microscopy finds application in the qualitative & quantitative analysis of Drugs in order to obtain information on the shape and surface structure of the material, an essential prerequisite to develop and maintain the industrial GMP requirements. In addition to this SEM is an important tool for characterization of nanoscale & sub-micron particles in addition to evaluating the Flow, compaction, dissolution properties, drug bioavailability, surface characterization, Shelf life analysis of the manufactured drug. The initial validation during process development and interpretation of results often require the high-resolution imaging and analysis capabilities of an electron microscope along with acting as an absolute reference standard to support the development of QC particle size distribution techniques. Scanning Electron Microscopy also plays a vital role in drug excipient homogeneity analysis to study the raw materials used in the formulation & their composition, and to analyze the distribution of the active ingredients within the excipient matrix in the final product. Several powdered cosmetic products are also evaluated using SEM for the analysis of shape, morphology, shelf life, surface characterization & many other elemental information of the product.

Spectro Instrumentation Facility for Testing of Cosmetics & Pharmaceuticals
  • HPLC
  • GC -FID
  • FT-IR
  • XRF
  • XRD
  • GC MS
  • LC-MS
  • SEM
  • ICP-MS
  • Salmonella
  • Total Organic Carbon (TOC) analyzer
  • Atomic Absorption Spectrophotometer)
  • UV/VIS Spectrophotometer
  • Clean Room Instruments
  • Compressed Air Monitoring Kits