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Validation and Experience

We Uphold the Trust Given to Us

Rifampicin

Salbutamol

Our tet and/or calibrations has accredited by the National Accreditation Committee of Indonesia (KAN) in ISO/IEC 17025 aspect

Validation and Analytical method development We have conducted method validation and development in a widerange of therapeutic areas. We are still developing our methods into more varied and advanced methods as we continously strive to lean and to develop our capabilities.

Validations

No. Compound Matrix Method LLOQ (ng/mL) Status
1 Rifampicin TSS 600 mg Plasma UHPLC UV Vis 200 Accredited
2 Salbutamol Table 4 mg Plasma LC MS/MS 0.2 Accredited
3 Esomeprazole Tablet 40 mg Plasma LC MS/MS 50 Validated
4 Favipiravir TSS 200 mg Plasma LC MS/MS 50 Validated
5 Lansoprazole Kapsul SR 30 mg Plasma LC MS/MS 10 Validated
6 Metformin Tablet 500 mg Plasma LC MS/MS 20 Validated
7 Ciprofloxacin TSS 500 mg Plasma UHPLC UV Vis 50 Validated
8 Meloxicam Tablet 15 mg Plasma LC MS/MS 10 Validated
9 Atorvastatin Tablet 20 mg Plasma LC MS/MS 0.1 Validated
10 Efavirenz TSS 600 mg dan Kapsul 200 mg Plasma UHPLC UV Vis 50 Validated
11 Tenofovir Tablet 300 mg Plasma LCMS/MS 1 Validated
12 Piroxicam Tablet 20 mg Plasma UHPLC UV Vis 75 Validated
13 Pioglitazone Tablet 30 mg Plasma LCMS/MS 25 Validated
14 Ketoconazole Tablet 200 mg Plasma UHPLC Fluoresence 100 Validated
15 Linezolid Tablet 600 mg Plasma LC MS/MS 300 Validated
16 Omeprazole Kapsul 200 mg Plasma LC MS/MS 5 Validated
17 Amlodipine Tablet 10 mg Plasma LC MS/MS 0,1 Partial Validation
18 Pantoprazole Tablet 40 mg Plasma LC MS/MS 50 Validated
19 Celecoxib Kapsul 200 mg Plasma LC MS/MS 10 Validated
20 Bilastine Tablet 50 mg Plasma LC MS/MS 5 Validated
21 Moxifloxacine TSS 400 mg Plasma UHPLC UV Vis 50 Partial Validation
22 Glimepirid 4 mg Plasma LC MS/MS 2 On Validation
23 Glibenclamide Plasma LC MS/MS - Trial Planned
24 Glicazide Tablet MR 60 mg Plasma UHPLC UV Vis - Validated
25 Zidovudine Kapsul 100 mg Plasma LC MS/MS - Validated
26 Azithromycin TSS 500 mg Plasma LC MS/MS 5 Validated
27 Valsartan TSS 80 mg dan 160 mg Plasma UHPLC - Fluoresence 5 Validated
28 Lamivudine TSS 300 mg Efavirenz TSS 400 mg dan 600 mg Plasma LC MS/MS 25 Validated
29 Etoricoxib Tablet 120 mg Plasma UHPLC UV Vis 10 Validated
30 Irbesartan Tablet 300 mg Plasma UHPLC - Fluoresence 30 Validated
31 Teofilin Tablet 300 mg Plasma UHPLC UV Vis 100 Validated
32 Simvastatin Tablet 20 mg Plasma LCMSMS 0,1 Validated
33 Molnupiravir 200 mg Tab Plasma LCMSMS 10 Validated
34 Rifampicin 300 mg+Isoniazid 150 Tab Plasma LCMSMS 50 On Progress
35 Candesartan 16 mg Tab Plasma LCMSMS 0,5 Validated
36 Bisoprolol 5 mg Tab Plasma LC MS/MS 0,5 Validated
37 Clopidogrel Tablet 75 mg Plasma LC MS/MS 0,005 On Progress
38 Telmisartan TSS 80 mg Plasma UHPLC - Fluoresence 3 On Progress
39 Tamsulosine Tablet 0,4 mg Plasma LC MS/MS 0,1 On Progress
40 Diltiazem HCl Tablet 30 mg Plasma LC MS/MS 5 Validated
41 Risperidone Tablet 2 mg Plasma LC MS/MS 0,1 On Progress
42 Isoniazid 300 mg Plasma LC MS/MS 20 Validated

Experience

No. Product Design Status
1 Uji BE Salbutamol 4 mg Tab 24 subyek, 2-way crossover, fasting, LCMSMS Done
2 Uji BE Rifampicin 600 mg Tab 21 subyek, 2-way crossover, fasting, UHPLC Ongoing
3 Uji BE Tenofovir 300 mg TSS 24 subyek, 2-way crossover, fasting, LCMSMS Done
4 Uji BE Meloxicam 15 mg Tab 16 subyek, 2-way crossover, fasting, LCMSMS Done
5 Uji BE Pioglitazone HCl 30 mg 30 subyek, 2-way crossover, fasting, LCMSMS Done
6 Uji BE Glimepirid 4 mg Tab 24 subyek, 2-way crossover, fasting, LCMSMS Done
7 Uji BE Favipiravir 200 mg TSS 30 subyek, 2-way crossover, fasting, LCMSMS Done
8 Uji BE Omeprazole 20 mg Kapsul 30 subyek, 2-way crossover, fasting, LCMSMS Ongoing
9 Uji BE Zidovudin 100 mg 32 subyek, 2-way crossover, fasting, UHPLC/LCMS Ongoing
10 Uji BE Efavirenz 200 mg TSS 28 subyek, 2-way crossover, fasting, UHPLC Done
11 Uji BE Azythromycin 500 mg TSS 32 subyek, 3-way partial replicate, fasting, LCMSMS Ongoing
12 Uji BE Sildenafil 100 mg TSS 30 subyek, 2-way crossover, fasting, LCMSMS Done
13 Uji BE Lanzoperazole 30 mg Kapsul 32 subyek, 2-way crossover, fasting, LCMSMS Done
14 Uji BE Simvastatin 20 mg Tab Subjek 28+2, Crossover, fasting, LCMSMS Ongoing
15 Uji BE Zidovudin 100 mg (Pilot) 7 subyek, 2-way crossover, fasting, UHPLC/LCMS Done
16 Uji Aplikasi TLE 334 dan 336 (2 subyek) 2 subyek, 2 way crossover, fasting, 2 bioanalisi LCMSMS Done
17 Uji BE Etoricoxib 80 mg Tablet Subjek 18+2, Crossover, fasting, UHPLC Ongoing
18 Uji BE Loprezol 30 mg kapsul Subjek 34+2, Crossover, fasting, LCMSMS Ongoing
19 Uji BE FDC 2 Subjek 22+2, Crossover, fasting, LCMSMS Ongoing
20 Uji BE TLE 336 Tablet (Skema 1) Subjek 28+2, Crossover, fasting, LCMSMS Ongoing
21 Uji BE Ethambutol Tab 500 mg Subjek 24+2, Crossover, fasting, LCMSMS Ongoing
22 Uji BE Isoniazid Tab 300 mg Subjek 22+2, Crossover, fasting, LCMSMS Ongoing
23 Uji BE Diltiazem Tablet 30 mg Subjek 16+2, Crossover, fasting, LCMSMS Ongoing
24 Uji BE Simvastatin 20 mg Tab (Plain) Subjek 31+2, Crossover, fasting, LCMSMS Ongoing
25 Uji BE TLE 336 Tablet (Skema 2) Subjek 28+2, Crossover, fasting, UHPLC Ongoing
26 Uji FDC 2 Anak Tablet Subjek 24+2, Crossover, fasting, LCMSMS Ongoing
27 Uji BE Ethambutol Tab 500 mg Subjek 24+2, Crossover, fasting, LCMSMS Ongoing
28 Uji BE Rifampicin 600 mg TSS Subjek 22+2, Crossover, fasting, UHPLC Ongoing
29 Uji BE Amlodipine 10 mg Tablet Subjek 16+2, Crossover, fasting, LCMSMS Ongoing

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