fa bitp//apps.usp.org/app/USPNFipviCalculation Tool/pvtPrintPage.. Performance Verification Test Calculation Tool Laboratory Information (optional) Date performed: | 09/1972018 Operator: | Art rana ‘Assembly ID: | Qc/ois-002 Note book: | USP Notes: | USP APPARATUS TYPE 2 Apparatus 2 ~ 1-stage test for equipment with 14 positions ff ‘Acceptance criteria for USP Prednisone Tablets RS, RO72MO 1 GeoMean, lower] 25 GooMean,uppor| 41 ‘seyupper| 67 vessel 10 Vessel Vessel 12 Vesso1 13 Verselt4 ‘Test Results Combined GeoMean 38 Moots Combined %2¢V 13 Moots Signatures qu PVT Cateulation Toot V2.0 opr 9 201 Th ted Sate Pharmac ope Camanon tof 9/25/2018, 10:34 AMDISSOLUTION CALIBR Product Name: Prednisone tablet PrednisoneUSP:- tomg [STD PREPARATION PROCEDURE: Weigh about 10 mg Prednisone.. SM esse sevens OMI With water |SPL PREPARATION PROCEDURE: 10mg Prednisone .....ecceou:.nn500mI with water Splabs x Std Wt.x 5 x 500 x purity x 100 IStd_ abs x50 x 50x Sol ciaim x 100 wavelength:-242 38 fae fae ae fae fae [30 fae [ae [ae fe fo fae LHSample Measurement Report Page 1/4 PrintDate: 09/19/2018 04:57:10 PM Dataset: September_2018 - 1-205-1 - PREDNISONE TABLET.unk ‘sample Graph Software Information 1.001 Software Name: UVProbe Version 2.80, Mode: LabSolutions Data Information Filename: Seplomber_2018 - 1.206-1 PREDNISONE TABLET unk Tite Rov2Mo Analyst ARTIRANA, soo Date/Time: 09/19/2018 04:57:09 PM é Comments: DISSOLUTION CALIBRATION < APPARATUS etueneene Instrument information Instrument Name: UV_PC Instrument Type: UV1800 Series Model (SIN). UV 1800 (A11454802450 CD) 0.000} -a.0ee! 1 10 15 ea ‘Sequence No, mole Table Sample Type Ex | wizazo Comments, T__ [BLANK Taknow 0.000 z= [sto Unknown 0.310 = [pt Urknowin 0.325 | OG/DIS-002 fa [or Gnknown 0386) [os Tnknovi 0332, oe Tain oa al 7__ [05 Unknow 0325) ops. Unknow 0.382 3 [or Unknow 0535) 73 [8 Unknow 0337 Tt [oe Unknow 033 [p10 Unknow 0382 73 [on Unknow os27 4 [ow Trknowin 0324 a Union 0.386) ie [oie Unknow 0.328 7 [ow Unknow (0.324 [OCIDIS-00t Te [016 Unknow 0396 ia [ow Unknow 0.383) De Unknow 0326 Di. Unknown 0380 20, Cnkovin 0334 a [bat Unknow 0828) el pes \a-eal®Page2/4 Sample Measurement Report PrintDate: 09/19/2018 0457-10 PM Dataset September_2018 - 1-205-1 - PREDNISONE TABLET.unk sample Graph Software Information 1.001 Software Name: UVProbe Version: 260 Mode: LabSolutions Data Information Filoname: ‘Septamber_2018 -1-205-t - PREDNISONE TABLET.unk Tite: RO72MO Analyst ‘ARTIRANA Date/Time: 09/19/2018 04:57:09 PA g 9500 Comments: DISSOLUTION CALIBRATION a APPARATUS. Instrument Information Instrument Name: UV_PC Inetument Type: UV-1800 Series Model (SIN); UV 1800 (A1 1454602450 CD) 0.000} 002! + 8 10 16 aoe Sequence No. sample Table ‘Samplei | Type | ex | wi2i20 ‘comments we [oz Taknown 227 EJ yee (BYOy-Sample Measurement Report Print Date: 09/1972018 Page 3/4 04:57:10 PM Dataset’ September_2018 - 1-205-1 - PREDNISONE TABLET.unk Wavelengths} ‘Wavelength Name: wi242.0 ‘Wavelength: 242,00 nm [calibration Curve) Cal, Curve Type: Raw Data [Measurement Parameters(Standard)) [Measurement Parameters(Samoe} Data Acquired by. Instrument Delay sample read Disabled Repeat Dissbod {Equations} iPass Fal] (ted Surman te DateTime oortaro1e 04:43:13 PM Comments: Sample Preparations: {instrument Properties] Instument Type y-1000 Series Measuring Mode: Rosorbance Sika ‘am iigntSource Change Wavelength: 340.0.0m ‘SIR Exchange Normal {attachment Properties) ‘Rtachmont None @ OePage 4/4 Sample Measurement Report Print Date: 09/19/2018 04:57:10 PM Dataset — September_2018 - 1-205-1 - PREDNISONE TABLET.unk History Description Dawertine User Sample ~ Added W222 0 Column De7ia72018 06:45:37 PM ART RANA ‘Samplo - Added Raw Data Parameters (06/16/2018 04:48:31 PW- ARTI RANA, ‘Sample = Added BLANK ROW. ‘05/18/2018 04:45:04 PM. TART! RANA ‘Sariple Added STD Row (06/18/2016 08:45:08 PM ARTI RANA ‘Sample - Added D1 Row. (09/18/2018 04:45:12 PM ARTI RANA ‘Seinple = Added D2 ROW. (0671972018 08:45:13 PM ARTI RANA, ‘Sample - Added D3 Row. ‘08/19/2018 04:45:15 PML ‘ARTI RANA Sample - Added D4 Row "08/10/2018 62-45.16 PUL ‘ARTI RANA, ‘Sample - Added 05 Row, ‘09/18/2018 04:45:17 PUL ‘ARTRANA, Sample - Added D6 Row (09/16/2016 04:45:10 PU. 'ARTIRANA, ‘Sample = Added D7 Row. (0/16/2018 04:45:20 PU 'ARTIRANA, Sample - Added D8 Row. ‘971072016 08:45:71 PUL "ARTTRANA, ‘Sample - Added 08 Row. ‘DarI972018 08:45:23 PUL “ARTTRANA. Sample = Added D10 Row (09/16/2076 04:45:26 PUL ARTI RANA ‘Sample - Added Dit Row (08/16/2016 08:45 28 PM ARTI RANA ‘Sample - Added O12 Row (0971672076 06:45°51 PM ARTI RANA ‘Sample - Added 013 Row. (0971072076 08:45:34 PML "ARTERANA. ample = Added D14 Row (0971872016 08:45'57 PME ‘ARTI RANA Tample Added D15 Row (0971072016 08:45:40 PM ‘ARTI RANA ‘Sainple= Added 016 Row (0671972018 08:45:43 PUL ‘ARTI RANA, ‘Sample - Added D17 Row (08/19/2018 64:45:57 PML ‘ARTTRANA, ‘Sample - Added D18 Row ‘06/10/2018 04:45:59 PUL ‘ARTI RANA ‘Sample- Added D19 Row (Dorier2016 64:46:03 PU "ARTI RANA, ‘Sample = Added D20 Row (971672018 04:26:07 PM "ARTIRANA, ‘Sample ~ Added D21 Row (0971672018 08:25:10 PM. ‘ARTTRANA, [Sample - Added 022 Row (09/18/2018 08:46:13 PM ARTI RANA [Fic Seated September 2018-12061 PREONISONE TABLET unk (0871072018 04:57:09 PME ARTI RANAlof Performance Verification Test Calculation Tool ‘htp:/fapps.usp.org/app/UISPNF/pvtCaleulationTool/pvtPrintPage... Laboratory Information (optional) camara eaieats peo |p Rane Teno: oD an2 mcrae le Tots | UoP APPARATUS HET See ee eee eee enn creer ie econ er] seu] i ae 7 7 aa 7 a aa am aa aa oe oeace aon marae me " ees ee ee aenat Cento 218 The ted Suto Pharmacol Conenon PVT Caleulation Too! V2.0 9125/2018, 10: SAMPINNACLE LIFE SCIENCE PVT.LTD. Village Manpura, Tehsil Baddi, Distt. Solan (H.P.) 174104 Product Name: Prednisone tablet 30-06-2019 [B.No.:RO72M0 Dssolution 1D:-_ QC/DIS-002_(BASK! Composition PrednisoneUSP:- 10mg }STD PREPARATION PROCEDURE: Weigh about 10mg Predinisone, Sm... .-50mi with water |SPL PREPARATION PROCEDURE: 10mg Prednisone 500ml with water (Calculation: [Spl abs x Std Wt.x 5 x 600 x purity X 100 LIMIT:-58% to 87% wavelength:-242 $.NO.. ABS _| % of drug rele: TAB 1 634 | 72.12 | % TAB 2 o641 | 7292 [| % TABS osat | 72.92 | % TAB oss | 7212 | % TABS o639 | 72.69 | % TAB 6 oes [73.26 | % TABT o636_| 72.35 | % TABS: 0634 | 7242 | % TAB 9 638 | 7258 | % TAB 10 o639 | 72.69 | % TABI 638 | 72.58 | %. TAB 42 9634 | 72.12 | % TABI3 osat | 7292 | % TAB 14 % Checked By: ‘Sid wt print attached with QC/DIS-002 Apparatus Paddle data sheetPoge 1/4 Sample Measurement Report PrintDate: 091192018 06:26:33 PM Dataset September_2018 - 1-209-1 - PREDNISONE.unk ‘Sample Graph ‘Software Information 1.008 Software Name: UVProbo Version 260, Mode: LabSotuions Data Information Filename: ‘September 2018 - 1-208 - PREDNISONE unk Tite Rov2M0 Analyst ARTI RANA, ae Date/Time: 09/19/2018 05:25:31 PML 3s Comments: DISSOLUTION APPARATUS BASKET Instrument Information Instument Name: UV_PC Instrument Type: UV"1800 Series Model (SIN): UV 1800 (A1 1484002450 CD) 0.000} -0.081 1 5 10 15 224 ‘Sequence No, snole Table Sample Type | ex | wi2azo ‘Comments 7 _[BLANK Taknow 0.000) 2 [sto Tnknow oid sam o1 Taknotin 0.634 [ACTOS 002 4 [oz Unknow o6at 5 [0s. Unknow O64t &__[be Unknow 0.634 7 [05 Unknown 0.539) ce Unknout 0644 s__[pr Trknowin 0.836 ie _[oe Unknow 0834 a Unknown 0.888) [00 Unknow 0.638 a Unknow 0.838 va [Diz Unknown 0.684 [Ds Trknown O6at a Unknow eae 7 [ow Waknow 0.634 | GCDIS-00F ie fore Trion 0857, io [ov Unknown 0838) [be WaKnown 0642, Hi [ore Unknown Oat 2 [p20 Unknown 0837 (leat nko 0.688 jwokessy OrPage 2/4 Sample Measurement Report Print Date: 0971972018 06:26:33 PM Dataset: September_2018 - 1-209-1 - PREDNISONE.unk Sample Graph ‘Software Information Software Name: UVProbe Version 2.80, Mode: LabSotutions Data Information Filename: ‘Septamber_2018 -1-209+41 - PREDNISONE unk Tie: RO72MO Analyst ARTI RANA Date/Time; 06/19/2048 06:26:91 Pa 3 Comments: DISSOLUTION APPARATUS BASKET Instrument Information Instrument Name: UV_PC Instrument Type: UV=1800 Series Model(SiN}; UV 1800.(A11454602450 CD) ee 10 18 2 ‘Sequence No. ‘Sample Table ‘SampleiD [Type | ex | wi2az0 ‘Comments [22 aknow 0.638 3Page 3/4 Sample Measurement Report PrintDate: 09/192018 052693 PM Dataset: -September_2018 - 1-209-1 - PREDNISONE.unk {Wevelengths} Wavelength Name: wi2a2.0 ‘Wavelenat 242.00 nm . [Calibration Curve} al. Curve Type: Row Data {Measurement Parameters(Standerd)] {Measurement Parameters(Sample)] Data Acguired by: Instrument Delay sample read: Disabled Repeat Disabled {Equations} [Pass Fall [Method Summary] Tite DateTime e/19/2018 06:10:13 PM ‘Comments: Samp Preparations [Instrument Properties) Instrument Type: Uv-1800 Series Measuring Mode: Absorbance: Sit Width: 10am Light Source Change Wavelength: 340.0 nm ‘SiR Exchange! Normal {Attachment Properties} ‘tachment None pei | OgSample Measurement Report Page 4/4 PrintDate: 09/19/2018 06:26:33 PM Dataset: September_2018 - 1-209-1 - PREDNISONE.unk tistory> Description Dateitime User Sariplo- Added WBZ Column DerTo2016 08:11:05 TART RANA ‘Sample - Added Raw Data Parameters ‘071672016 06:11:00 PW ‘ARTIRANA. ‘Sample Added BLANK Row (09772016 06:12:53 Phi ‘ARTIRANA, ‘Sample - Added STD Row (erte2016 06-12:55 PU 'ARTIRANA, ‘Semple - Added D1 Row (071872018 06:12:59 PU ‘ARTIRANA, ‘Sample - Added 2 Row ‘96/19/3018 08:13:07 PML ‘ARTI RANA — ‘Sample - Added D3 Row ‘06/18/2018 08:13:02 PME 'ARTIRANA ‘Sample - Added D4 Row. ‘08/19/2016 06:13:03 PW ‘ARTIRANA, ‘Sample = Added DS Row (0871673018 08:13:05 PAL ARTI RANA ‘Sample - Added 06 Row. (08719/3018 08:13:08 PM "ARTI RANA, ‘Sample - Added D7 ROW. ‘05716/2018 06:73:10 PME ARTIRANA, ‘Sample - Added D& Row. ‘06716/2018 06:13:12 PAE TART! RANA ‘Sample = Added D8 Row. ‘9718/2018 06:13:14 Pi 'ARTIRANA ‘Sample - Added D10 Row ‘6718/2078 06:13:16 PM ARTI RANA ‘Sample ~ Added D11 Row ‘9671672078 06:13:18 PH ARTI RANA ‘Sample - Added D12 Row ‘96/18/2076 06:13:21 PM "ARTVRANA. ‘Sample - Added D13 Row ‘09/18/2018 06:13:26 PM ARTI RANA ‘Sample - Added D14 Row ‘09/16/2078 06:13.20 PME “ARTERANA. ‘Sample - Added DIS Row ‘09/16/2018 06:13:35 PM. ARTI RANA ‘Sample - Added D16 Row (06/16/2018 06:13'52 PM. ARTI RANA, ‘Sample - Added D17 Row ‘09/18/2016 06:19:58 PM. ARTI RANA ‘Sample Added D18 Row ‘ar1s/20%8 06:14:17 PM [ARTI RANA ‘Sample - Added D19 Row ‘ar1e/20%8 06:14:19 PM. TARTIRANA, ‘Sample = Added D20 Row ‘06/16/2016 06:14:22 PU "ARTIRANA. ‘Sample - Added 021 Row (06/16/2016 06:14:23 PU. “ARTIRANA. ‘Sample - Added 022 Row (0671672018 06:14:25 PM "ARTIRANA. [Fie created September_20781-200-1 - PREDNISONE unk (09/16/2018 06:26:31 PM "ARTIRANA Noy OMe ae