This Certificate of Analysis was issued by PT Saraswanti Indo Genetech (Bogor, Indonesia) for Sumatra Pasak Bumi's Tongkat Ali capsules (Pasak Bumi Kapsul 300 mg). The COA covers a comprehensive range of tests including heavy metals, microbiology, narcotics and psychotropic substances, and PDE5 inhibitor screening.
I. Sample Information
Certificate of Analysis issued by PT Saraswanti Indo Genetech — Page 1 (click to enlarge)
Report number
SIG.LHP.X.2017.66366
Client
PT Sumatera Pasak Bumi
Address
Jl. Cempaka IV, Dusun IV, Desa Tuntungan I, Kec. Pancur Batu, Kab. Deli Serdang, Sumatera Utara
Sample name
Pasak Bumi Kapsul 300 mg (Tongkat Ali capsules)
II. Organoleptic & Physical Properties
Certificate of Analysis issued by PT Saraswanti Indo Genetech — Page 2 (click to enlarge)
Parameter
Result
Method
Odour
Normal
SNI 01-2891-1992
Taste
Bitter
SNI 01-2891-1992
Colour
Capsule: colourless; contents: brown
SNI 01-2891-1992
Form
Powder-filled capsule
SNI 01-2891-1992
III. Heavy Metals (ICP-OES Method)
✓ Mercury and arsenic not detected. Lead and cadmium detected at trace levels typical of plant-derived materials and well within accepted limits.
Metal
Result
Units
Detection limit
Method
Lead (Pb)
1.83
ppm
—
ICP-OES
Cadmium (Cd)
0.16
ppm
—
ICP-OES
Mercury (Hg)
Not detected
ppm
0.004
ICP-OES
Arsenic (As)
Not detected
ppm
0.008
ICP-OES
IV. Microbiology
✓ All pathogens negative. Total plate count and yeast/mold count within normal range.
Parameter
Result
Units
Method
Total plate count (ALT)
2.0 × 10
colony/g
SIG method
Yeast and mold
< 10
colony/g
SIG method
Escherichia coli
Negative
/g
SIG method
Salmonella sp.
Negative
/g
SIG method
Staphylococcus aureus
Negative
/g
SIG method
Pseudomonas aeruginosa
Negative
/g
SIG method
Shigella sp.
Negative
/g
ISO 21567:2004
V. Narcotics & Psychotropic Substances Screening (LC-MS/MS)
About this screening
This test confirms that the product contains no controlled narcotics or psychotropic substances. All results are negative, independently verified by an accredited third-party laboratory.
Substance
Result
Method
Opium
Negative
LC-MS/MS
Codeine phosphate
Negative
LC-MS/MS
Morphine HCl
Negative
LC-MS/MS
Marijuana
Negative
LC-MS/MS
Phenobarbital (Luminal)
Negative
LC-MS/MS
Diazepam
Negative
LC-MS/MS
Amphetamine sulphate
Negative
LC-MS/MS
Benzodiazepine
Negative
LC-MS/MS
VI. Undeclared PDE5 Inhibitor Screening (LC-MS/MS)
Why this test matters
Sildenafil, tadalafil, and vardenafil are pharmaceutical compounds that are occasionally found illegally added to men's health supplements. This independent screening confirms that Sumatra Pasak Bumi's Tongkat Ali contains none of these substances.
Substance
Result
Method
Sildenafil citrate
Negative
LC-MS/MS
Tadalafil
Negative
LC-MS/MS
Vardenafil HCl
Negative
LC-MS/MS
VII. Additional Quality Parameters
Parameter
Result
Units
Method
Moisture content
4.8
%
SNI 01-2891-1992
Disintegration time
2 min 15 sec
—
Indonesian Pharmacopeia
Capsule weight uniformity
0.2889
g
Indonesian Pharmacopeia
Approved by
Dwi Yulianto Laksono S.Si
Title
Laboratory Manager, PT Saraswanti Indo Genetech
Laboratory address
Graha SIG, Jl. Rasamala No.20, Taman Yasmin, Bogor 16113, Indonesia
