Analytical & Advisory Services Division

Pharmaceutical Chemistry Section

About the Section

This Section examines pharmaceutical items for compliance with national pharmacopoeial standards, such as the British Pharmacopoeia and the United States Pharmacopeia and support to the market surveillance programme for monitoring the quality of the local registered pharmaceutical products.

Pharmaceutical Samples

Pharmaceutical Samples

Responsibilities

This Section conducts analyses for enforcement of the following Ordinances:

  • The Pharmacy and Poisons Ordinance
  • The Antibiotics Ordinance

In addition, the Section analyses pharmaceutical products, which are submitted by the Department of Health and the Hospital Authority, to check on the compliance with specifications.

Quality Assurance

About 20% of the tests conducted in the Section are for QC purpose.

Key Instruments

The following instruments are used routinely by the Section:

  • Liquid Chromatograph with High Resolution Mass Spectrometer (LC-HRMS)
  • Liquid Chromatograph with Tandem Mass Spectrometer (LC-MS/MS)
  • Matrix-Assisted Laser Desorption Ionization Time-of-Flight Mass Spectrometer (MALDI-TOF MS)
  • High Performance Liquid Chromatograph with various detectors
  • Gas Chromatograph with various detectors
  • Inductively Coupled Plasma Mass Spectrometer (ICP-MS)
  • Fourier Transform Infrared Spectrometer
  • UV Spectrophotometer
  • Fluorescence Spectrophotometer
  • Capillary Electrophoresis System
  • Disintegration Tester
  • Dissolution Tester
  • Density Meter
  • Flow Injection Analyzer
MALDI-TOF MS

MALDI-TOF MS

Targets and Key Indicators

Key Performance Measures Relating to the Statutory Testing of Pharmaceuticals

Targets #
Targets 2019 (Actual) 2020 (Actual) 2021 (Plan)
95 100 100 95

Targets 2019 (Actual) 2020 (Actual) 2021 (Plan)
95 99 98 95

# For targets where reporting time is mentioned, different samples require different analytical procedures, hence different reporting time. The quoted number of working days required represents an average of reporting time for the different types of samples and test requests within the category, while the target (in percentage) is the total compliance rate of the concerned samples and test requests within a particular category against their respective targets.

Key Indicators
Tests Performed on Pharmaceuticals 2019 (Actual) 2020 (Actual) 2021 (Estimate)
Urgent samples relating to
pharmaceutical incidents
6 156 N.A.
Other pharmaceutical samples 51,562 51,467 51,000

¶ As the testing requirements for urgent samples relating to food, pharmaceuticals and Chinese medicine incidents fluctuated in previous years, it is difficult to estimate either the occurrence of these type of incidents or the number of tests required.