Quality Assurance

Checklist for sample preparation

Checklist for sample preparation

Checklist for Do’s

  • Use a heating mantel or burner with glass beads to avoid bumping.
  • Specific gravity – check the temperature during the analysis
  • Weight/ml – avoid air bubbles in the tube.
  • Polarimeter – Avoid air bubbles in the cell.
  • For melting point, powder the substance to fine particles & fill in the capillary which is closed at one end, and make a compact bed by tapping in the capillary, to avoid air gaps in the capillary.
  • For tap density: Use a dry cylinder.
  • For LOD, sulphated ash, etc. keep cooling time constant.
  • In the case of solid IR mix the substance with previously dried KBr & in proportion.
  • In the case of liquid IR, avoid contact with an aqueous medium.

Checklist for Do’s and Don’ts

  • Don’t heat the solution without a glass bead.
  • Don’t use cold & hot material directly for analysis of specific gravity.
  • Don’t take a reading if an air bubble is observed
  • Don’t take a reading if an air bubble is observed
  • Don’t use capillary if a gap is observed for melting points
  • Don’t use a we cylinder for tap density analysis.
  • Don’t keep the LOD bottle & Crucible for cooling more than 30 minutes.
  • Don’t use KBR as such for the preparation of pellets
  • Don’t use liquid cells having scratches for analysis

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube