Certificate of Analysis
No 28 1/P PP/SMM SIGRevisi 3
Result of Analysis
No: SIG.LHP.X2017.66366
No. 1, Parameter Bau, Unit - , Result Normal, Limit of Detection - Method SNI 01-2891-1992 butir 1.2
No. 2, Parameter Resa, Unit - , Result Pajit, Limit of Detection - Method SNI 01-2891-1992 butir 1.2
No. 3, Parameter Warna, Unit - , Result Kapsul : tidak bewarna, isi: coklat, Limit of Detection - Method SNI 01-2891-1992 butir 1.2
No. 4, Parameter Bentuk, Unit - , Result Kapsul isi serbuk, Limit of Detection - Method SNI 01-2891-1992 butir 1.2
No. 5, Parameter Pb, Unit ppm , Result 1.83, Limit of Detection - Method 18-13-8/MU/SMM-SIG, ICP-OES
No. 6, Parameter Cd, Unit ppm , Result 0.16, Limit of Detection - Method 18-13-8/MU/SMM-SIG, ICP-OES
No. 7, Parameter Hg, Unit ppm , Result not detected, Limit of Detection 0.004 Method 18-13-8/MU/SMM-SIG, ICP-OES
No. 8, Parameter As, Unit ppm , Result not detected, Limit of Detection 0.008 Method 18-13-8/MU/SMM-SIG, ICP-OES
No. 9, Parameter ALT, Unit colony/g, Result 2.0x10 , Limit of Detection - Method 18-7 6/MU/SMM-SIG
No. 10, Parameter Kapang Khamir, Unit colony/g, Result <10 , Limit of Detection - Method 18-7 6/MU/SMM-SIG
No. 11, Parameter Escherichia coli, Unit / g, Result Negative, Limit of Detection - Method 18-7 6/MU/SMM-SIG
No. 12, Parameter Salmonella sp, Unit / g, Result Negative, Limit of Detection - Method 18-7 6/MU/SMM-SIG
No. 13, Parameter Staphylococcus aureus, Unit / g, Result Negative, Limit of Detection - Method 18-7 6/MU/SMM-SIG
No. 14, Parameter Pseudomonas auruginosa, Unit / g, Result Negative, Limit of Detection - Method 18-7 6/MU/SMM-SIG
No. 15, Parameter Shigella sp, Unit / g, Result Negative, Limit of Detection - Method ISO 21567 : 2004
No. 16, Parameter Kadar air, Unit %, Result 4.8, Limit of Detection - Method SNI 01-2891-1992 butir 5.1
No. 17, Parameter Waktu hancur, Unit -, Result 2 menit, 15 detik, Limit of Detection - Method Farmakope Indonesia
No. 18, Parameter Keseragaman, Unit gram, Result 0.2889, Limit of Detection - Method Farmakope Indonesia
No. 19, Parameter Narkotika & Psikotoprika
Parameter Opium, Unlt - Result Negative, Limit of Detection - Method 18-12-8/MU/SMM/-SIG, LC MSMS
Parameter Kodeln Fosfat, Unlt - Result Negative, Limit of Detection - Method 18-12-8/MU/SMM/-SIG, LC MSMS
Parameter Morpin HCL, Unlt - Result Negative, Limit of Detection - Method 18-12-8/MU/SMM/-SIG, LC MSMS
Parameter Mariyuana, Unlt - Result Negative, Limit of Detection - Method 18-12-8/MU/SMM/-SIG, LC MSMS
Parameter Luminal, Unlt - Result Negative, Limit of Detection - Method 18-12-8/MU/SMM/-SIG, LC MSMS
Parameter Diazepam, Unlt - Result Negative, Limit of Detection - Method 18-12-8/MU/SMM/-SIG, LC MSMS
Parameter Amfetamin Sulfat, Unlt - Result Negative, Limit of Detection - Method 18-12-8/MU/SMM/-SIG, LC MSMS
Parameter Benzoadiazepin, Unlt - Result Negative, Limit of Detection - Method 18-12-8/MU/SMM/-SIG, LC MSMS
No. 20, Parameter Sildenafil Sitrat, Unit gram, Result Negative, Limit of Detection - Method 18-12-8/MU/SMM/-SIG, LC MSMS
No. 21, Parameter Tadalafil, Unit gram, Result Negative, Limit of Detection - Method 18-12-8/MU/SMM/-SIG, LC MSMS
No. 22, Parameter Vardenafil HCL, Unit gram, Result Negative, Limit of Detection - Method 18-12-8/MU/SMM/-SIG, LC MSMS
Bogor, October 26, 2017
PT Saraswanti Indo Genetech
DWI Yulianto Laksono. S.Si
Manager, Laboratorium
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