Chemical Analysis

The chemical laboratory at Viva performs tests in accordance with monographs from USP and AOAC.  Various in-house methods have been developed and validated to test hard-to-extract active ingredients.  The tests are performed by a laboratory that meets all relevant cGMP / GMP requirements:

 i)        Raw Materials

  • Identification – to make sure the active ingredients exist in the materials
  • Physical – loss on drying, Karl Fischer, particle size and pH
  • Quantification – to make sure the amount of active ingredients meet the specification
  • Impurity – to make sure that impurities (such as Pb, Cd, Hg, As, volatile substances, PCB, and pesticides), are within allowable limits
  • Physicochemical Characterization – peroxide value, acid value, anisidine value and TOTOX

ii)      Products

  • Physical – weight variation, filling weight, disintegration, rupture test, friability, tablet size, hardness and shell moisture
  • Chemical – to guarantee the amount of active ingredients meet the specification
  • Stability – to determine appropriate storage conditions and expiration dates of products
  • where applicable, additional tests will be conducted on finished products (e.g. dissolution, uniformity of dosage units, and impurity tests)

iii)    Equipment

  • Gas Chromatography (with flame ionization detector and headspace)

Model: Thermo Scientific Trace 1310 & Triplus

  • Gas Chromatography Mass Spectrometer

Model: Trace GC ULTRA/TRIPLUS/ISQ Mass Spectrometer

  • High Performance Liquid Chromatography (with UV, PDA, and ELSD detectors) Thermo Scientific

Model: Waters 2695/2487/996/2420

  • Ultra Performance Liquid Chromatography

Model: Waters Acquity UPLC

  • Ultraviolet / Visible Absorption Spectrometer

Model: Shimadzu UV-1601

  • Infrared Absorption Spectrometer (FTIR)

Model: Thermo Scientific Nicolet 6700/Smart iTR

  • Inductively Coupled Plasma – Optical Emission Spectrometer (ICP-OES)

Model: Thermo Fisher Scientific iCAP 6000 series

  • Tablet Hardness Tester

Model: Pharma Test

  • Dissolution Tester

Model: Logan Instrument VTC-200 D-800 & Shin Kwang Machinery DT-8

  • Karl Fischer titration

Model: Metrohm 870 KF Titrino Plus

  • Disintegrator

Model: Hanson Research QC-21

  • Friability Tester

Model: Shin Kwang Machinery SK-32020

  • Polarimeter

Model: Anton Paar MCP 100

  • Refractometer

Model: Anton Paar Abbemat 350

  • Centrifuge

Model: Beckman Coulter Allegra 25R Centrifuge

  • Rotary Evaporator

Model: Buchi B-480

  • Melting Range Meter

Model: Electrothermal Engineering LTD

  • Texture Analyzer

Model: CNS FARNELL

  • Microwave Digester

Model: CEM Discover SPD/ Explorer 24/48

  • Total Organic Carbon Analyzer

Model: Shimadzu TOC-Vws

  • Liquid Chromatography Mass Spectrometer

Model: Thermo Scientific Fennigan LCQ Advantage Max/Surveyor PDA plus Detector 

 

Heavy Metals

The Inductively Coupled Plasma – Optical Emission Spectrometer technology is well established, versatile in terms of sample matrixes, and has high throughputs which is advantageous for maintaining the economics of scale when processing samples.  Specific elements that are typically assayed include lead, mercury, bismuth, arsenic, antimony, tin, cadmium, silver, copper, and molybdenum.

                         

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