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Chinese Proprietary Medicine

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Chinese Proprietary Medicine (CPM)

Chinese Proprietary Medicine (CPM) refer to medicinal products, used according to the traditional Chinese medicine (TCM) system of therapeutics, that have been manufactured into finished dosage forms (for example, tablets, capsules, pills). More Stringent Regulations on Chinese Proprietary Medicines in Singapore, due to the rise of health related problems in the past as a result of CPM consumption, the Ministry is tightening its control of the marketing and testing of Chinese traditional medicines. The new regulations will include additional labeling requirements for CPMs as well as more comprehensive test reports issued by accredited laboratories.

Accredited Laboratories 认证实验室

As an accredited laboratory under SAC-SINGLAS, in Eurofins Mechem, we provide the analytical service for CPM testing as required, including: 

  • Toxic heavy metals
  • Microbial contamination
  • Other substances as may be required by HSA

Parameters to be Tested and Their Limits 检测要求的项目及检测结果的限定范围

Toxic heavy metal limits for CPM are as follows (有毒重金属的限量标准):

HEAVY METAL
重金属
PERMISSIBLE LIMITS
限量
REVISED LIMITS
FROM 1 SEP 2019#
修订后的限量
(2019年9月1日起)#

Arsenic  砷

5 ppm

5 ppm

Cadmium 镉

-

0.3 ppm

Copper  铜

150 ppm

-

Lead  铅

20 ppm

10 ppm

Mercury  汞

0.5 ppm

0.5 ppm

Microbial limits for CPM are as follows (微生物的限量标准):

FOR ORAL CPM
中成药(口服)
MICROBIAL LIMITS 
限量

Total aerobic microbial count

需氧微生物的总数

Not more than 105 CFU per g or ml

每一克或一毫升不超过 10CFU

Yeast and mould count

酵母及霉菌

Not more than 5 X 102 CFU per g or ml

每一克或一毫升不超过 5 X 102 CFU

Escherichia coli 大肠埃希氏杆菌
Salmonellae 沙门氏菌族
Staphyloccocus aureus 金黄色葡萄球菌

Absent in 1g or ml

每一克或一毫升的药品不能含有

FOR TOPICAL CPM
中成药(外用)
MICROBIAL LIMITS 
限量

Total aerobic microbial count

需氧微生物的总数

Not more than 104 CFU per g or ml

每一克或一毫升不超过 10CFU

Yeast and mould count

酵母及霉菌

Not more than 5 X 10CFU per g or ml

每一克或一毫升不超过 5 X 102 CFU

Pseudomonas aeruginosa 绿脓假单胞菌
Staphyloccocus aureus 金黄色葡萄球菌

Absent in 1g or ml

每一克或一毫升的药品不能含有

Contact

For more detailed information on vitamin testing please contact your local Eurofins laboratory.