An Update on Quality Control of Traditional Medicines

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An Update on Quality Control of Traditional Medicines

Ministry of Health Malaysia

National Pharmaceutical Control Bureau

Yogeswary Markandoo,

Deputy Director, Centre for Quality Control.

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OBJECTIVE

SafetyQuality

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Tests for Safety and Quality

Limit tests for Heavy Metals

Microbial limit tests

Disintegration test – tablets, capsules and pills

Uniformity of weight – tablets and capsules

Absence of scheduled medicines, banned alkaloids, synthetic chemicals.

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Limit tests for Heavy Metals

Lead ≤ 10.0ppm Arsenic ≤ 5.0ppm

Mercury ≤ 0.5ppm

Cadmium ≤ 0.3ppm (from 1 January 2005)

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Ministry ofHealth Malaysia


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Microbial Limit Test

Total viable aerobic count : Bacteria and Fungus

Enterobacteria and certain other Gm negative bacteria

Free from Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa and Salmonella

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Disintegration Test (for tablets, capsules and pills)

Uncoated Tablets

Film coated Tablets

Sugar coated Tablets

Enteric coated Tablets

Capsules

Pills

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Uniformity of Weight (tablets and capsules only)

≤ 2 tablets/ capsules > 10% of the average and none > 20% of the average weight

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http://www.bpfk.gov.my

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Absence of :- Adulterants - scheduled

medicines (Poisons Act 1953)

Banned plants/alkaloids

Synthetic chemicals

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Statistics (2003 and 2004)Traditional medicines Year Number of

traditional samples

tested

Number of traditional samples failed

lab tests

% failed

2003 2615 298 11.4

2004 3404 429 12.6

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Future Tests

Limit test for pesticide residues

Limit test for residual solvents

Limit test for moisture content

Presence of aflatoxins

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Documents

An Update on Quality Control of Traditional Medicines