Estanadar Propranolol clorhidrato usp

lote: I1G348 99.90%

vencimento : viegente
Linealidad del Sistema

Nivel mg/mL Absorbancia FACTOR DE RESPUESTA

0.00500 0.2040 40.80
25 0.00500 0.2040 40.80
0.00500 0.2043 40.86
0.01000 0.3959 39.59
50 0.01000 0.3959 39.59
0.01000 0.3982 39.82
0.01500 0.5823 38.82
75 0.01500 0.5834 38.89
0.01500 0.5845 38.96
0.02000 0.7818 39.09
100 0.02000 0.7885 39.43
0.02000 0.7895 39.48
0.02500 0.9833 39.33
125 0.02500 0.9826 39.30
0.02500 0.9790 39.16
promedio 0.5905 39.5944

FILTRO
SIN FILTRADO
0.7854 0.8057
0.7845 0.8007
0.7828 0.8081
0.7855 0.8012
0.7847 0.8085
0.7844 0.8058
PROM 0.7846 0.8050 PROM
% 100.00 102.60 %
difer. Abs 2.60 difer. Abs

Resumen

Estadsticas de la regresin eror relativo

Coeficiente de cor 0.9998910696 0.7386334315
Coeficiente de de 0.9997821512
R^2 ajustado 0.9997653936
Error tpico 0.0043614088
Observaciones 15

ANLISIS DE VARIANZA
Grados de libertadSuma de cuadrados Promedio de los cuadrados
Regresin 1 1.1348724903 1.1348724903
Residuos 13 0.0002472845 1.90218869230768E-05
Total 14 1.1351197748

Coeficientes Error tpico Estadstico t

Intercepcin 0.006979 0.0026409642 2.6425954645
mg/mL 38.8994 0.159256133 244.2568412767

Anlisis de los residuales

Observacin Pronstico Absorbancia Residuos

1 0.201476 0.002524
2 0.201476 0.002524
3 0.201476 0.002824
4 0.395973 -0.000083
5 0.395973 -0.000073
6 0.395973 0.002217
7 0.59047 -0.0082
8 0.59047 -0.0071
9 0.59047 -0.006
10 0.784967 -0.003167
11 0.784967 0.003563
12 0.784967 0.004533
13 0.979464 0.003856
14 0.979464 0.003096
15 0.979464 -0.000514
 cv

1.75

estabilidad
inicio final
0.7854 0.7966
0.7845 0.7981
0.7828 0.7988
0.7855 0.7972
0.7847 0.7980
0.7844 0.7981
0.7846 0.7978
100.00 mg/mL
101.69Curva de regresin ajustada
1.691.5000
Absorbancia
Absorbancia

1.0000
f(x) = 38.8994x + 0.006979 Pronstico Absorbancia
0.5000 Linear (Pronstico
Absorbancia)
0.0000
0.00000 0.01000 0.02000 0.03000
mg/mL
 F Valor crtico de F
59661.404510465 3.425113196E-25

Probabilidad Inferior 95% Superior 95% Inferior 95.0% Superior 95.0%

0.0202955793 0.0012735437 0.0126844563 0.0012735437 0.0126844563
3.4251131963E-25 38.5553480419 39.2434519581 38.5553480419 39.243451958
PRODUCTO INDERAL 40 Mg
Lote: 448577
Fab : Jun-15
Vence: Jun-18

Linealidad del Metodo Dia 1 Linealidad del Metodo Dia 2

Nivel mg/mL Absorbancia Nivel mg/mL
0.00500 0.2132 0.00500
25 0.00500 0.2140 25 0.00500
0.00500 0.2143 0.00500
0.01000 0.4036 0.01000
50 0.01000 0.4072 50 0.01000
0.01000 0.4082 0.01000
0.01500 0.5923 0.01500
75 0.01500 0.5934 75 0.01500
0.01500 0.5945 0.01500
0.02000 0.7918 0.02000
100 0.02000 0.7985 100 0.02000
0.02000 0.7995 0.02000
0.02500 0.9933 0.02500
125 0.02500 0.9926 125 0.02500
0.02500 0.9990 0.02500

Perfil de disolucion Medicamento de referencia

Tiempo Min 10 15 20 25 30
No. Absorbancia Absorbancia Absorbancia Absorbancia Absorbancia
1 0.3544 0.46728 0.5388 0.6544 0.7899
2 0.3058 0.46526 0.5842 0.6399 0.7955
3 0.3244 0.45392 0.5377 0.6455 0.7953
4 0.3462 0.41353 0.5563 0.65 0.7845
5 0.3345 0.44875 0.5244 0.6453 0.7753
6 0.3452 0.43662 0.5312 0.6345 0.7645
7 0.3245 0.42742 0.4522 0.6499 0.7566
8 0.3512 0.38219 0.5433 0.6344 0.7644
9 0.3148 0.44407 0.5244 0.6499 0.7644
10 0.3144 0.43262 0.5433 0.6458 0.7566
11 0.3245 0.37932 0.5177 0.6433 0.7862
12 0.3244 0.41587 0.5133 0.6522 0.7455
del Metodo Dia 2
Absorbancia
0.2168
0.2108
0.2119
0.4007
0.4021
0.4031
0.5944
0.5940
0.5938
0.7928
0.8147
0.7954
0.9896
0.9805
0.9801
PRODUCTO INDERAL 40 Mg
Lote: 448577
Fab : Jun-15
Vence: Jun-18

Linealidad del Metodo Dia 1

Nivel mg/mL Absorbancia Contenido Real % reuperado Error prom
0.00500 0.2132 0.0050686642 101.373284461 1.3732844614
25 0.00500 0.2140 0.0050891508 101.783016275 1.7830162749
0.00500 0.2143 0.0050968333 101.936665705 1.9366657049
0.01000 0.4036 0.0099444728 99.444728032 0.555271968
50 0.01000 0.4072 0.0100366625 100.366624612 0.3666246122
0.01000 0.4082 0.0100622707 100.622706996 0.6227069957
0.01500 0.5923 0.0147759791 98.50652754 1.49347246
75 0.01500 0.5934 0.0148041482 98.6943212878 1.3056787122
0.01500 0.5945 0.0148323173 98.8821150356 1.1178849644
0.02000 0.7918 0.0198855909 99.4279546359 0.5720453641
100 0.02000 0.7985 0.0200579344 100.289671856 0.289671856
0.02000 0.7995 0.0200827744 100.413871812 0.413871812
0.02500 0.9933 0.0250461631 100.184652471 0.1846524706
125 0.02500 0.9926 0.0250267009 100.106803426 0.106803426
0.02500 0.9990 0.0251903375 100.761349998 0.761349998
Promedio 0.6010 Promedio 0.8588667387

Linealidad del Metodo Dia 2

Nivel mg/mL Absorbancia Contenido Real % reuperado CV global
0.00500 0.2168 0.00516111 103.22219927
25 0.00500 0.2108 0.0050064362 100.128724078
0.00500 0.2119 0.0050346053 100.692105322
0.01000 0.4007 0.0098709772 98.7097715916
50 0.01000 0.4021 0.0099055483 99.0554828092
0.01000 0.4031 0.0099311565 99.3115651926
0.01500 0.5944 0.0148292443 98.8616284449
75 0.01500 0.5940 0.0148195131 98.7967542412 1.213%
0.01500 0.5938 0.014815928 98.7728532187
0.02000 0.7928 0.0199122235 99.5611174752
100 0.02000 0.8147 0.0204730439 102.365219574
0.02000 0.7954 0.0199770123 99.8850616902
0.02500 0.9896 0.0249514126 99.8056505432
125
 125 0.02500 0.9805 0.0247176094 98.8704376789
0.02500 0.9801 0.024706854 98.8274158385

Resumen

Estadsticas de la regresin Error relativo

Coeficiente d 0.9998604459 0.8245622776
Coeficiente 0.9997209114
R^2 ajustado 0.999699443
Error tpico 0.0049557677
Observacione 15

ANLISIS DE VARIANZA
Grados de libertad
Suma de cuadrados
Promedio de los cuadrados F Valor crtico de F
Regresin 1 1.14367297 1.14367297 46567.1837417 1.7139624E-24
Residuos 13 0.0003192752 2.455963359E-05
Total 14 1.1439922452

Coeficientes Error tpico Estadstico t Probabilidad Inferior 95%

Intercepcin 0.015269 0.0030008664 5.0881972427 0.0002080053 0.0087860223
mg/mL 39.049933333 0.1809590509 215.7943088724 1.7139624E-24 38.6589950716

Anlisis de los residuales

Observacin
Pronstico AbsorbanciaResiduos
1 0.2105186667 0.0026813333
2 0.2105186667 0.0034813333
3 0.2105186667 0.0037813333
4 0.4057683333 -0.002168333
5 0.4057683333 0.0014316667
6 0.4057683333 0.0024316667
7 0.601018 -0.008748
8 0.601018 -0.007648
9 0.601018 -0.006548
10 0.7962676667 -0.004467667
11 0.7962676667 0.0022623333
12 0.7962676667 0.0032323333
13 0.9915173333 0.0018026667
14 0.9915173333 0.0010426667
15 0.9915173333 0.0074326667
CV global

0.0105
 mg/mL Curva de regresin ajustada
1.5000
Absorbancia
Absorbancia

1.0000
f(x) = 39.0499333333x + 0.015269 Pronstico Absorbancia
0.5000 Linear (Pronstico
Absorbancia)
0.0000
crtico de F 0.00000 0.01000 0.02000 0.03000
mg/mL

Superior 95% Inferior 95.0% Superior 95.0%

0.0217519777 0.0087860223 0.0217519777
39.4408715951 38.6589950716 39.440871595
PRODUCTO PROPRANOLOL CLORHIDRATO 40 mg GENFAR
Lote: 124577
Fab : Jun-16
Vence: Jan-18

Linealidad del Metodo dia 1 Linealidad del Metodo

Nivel mg/mL Absorbancia Nivel

0.00500 0.2032
25 0.00500 0.2040 25
0.00500 0.2043
0.01000 0.3959
50 0.01000 0.3973 50
0.01000 0.3982
0.01500 0.5823
75 0.01500 0.5834 75
0.01500 0.5845
0.02000 0.7818
100 0.02000 0.7885 100
0.02000 0.7895
0.02500 0.9833
125 0.02500 0.9826 125
0.02500 0.9790

Perfil de disolucion Medicamento de Prueba

Tiempo Min 5 10 15 20
No. Absorbancia Absorbancia Absorbancia Absorbancia
1 0.5044 0.6977 0.6844 0.7322
2 0.5133 0.7011 0.6944 0.7844
3 0.5433 0.6577 0.7066 0.7899
4 0.486 0.6544 0.6899 0.7786
5 0.5188 0.6842 0.6954 0.7711
6 0.4955 0.6145 0.6345 0.7561
7 0.4799 0.6244 0.6544 0.756
8 0.5033 0.6145 0.6499 0.764
9 0.5133 0.6244 0.6644 0.7612
10 0.5001 0.6344 0.6485 0.756
11 0.5177 0.6144 0.6574 0.78
12 0.4899 0.6245 0.6544 0.7512
Linealidad del Metodo dia 2

mg/mL Absorbancia
0.00500 0.2068
0.00500 0.2008
0.00500 0.2019
0.01000 0.4007
0.01000 0.3921
0.01000 0.3931
0.01500 0.5844
0.01500 0.5840
0.01500 0.5838
0.02000 0.7828
0.02000 0.7847
0.02000 0.7854
0.02500 0.9896
0.02500 0.9805
0.02500 0.9801

30
Absorbancia
0.7599
0.7955
0.7953
0.7845
0.7753
0.7645
0.7566
0.7644
0.7644
0.7566
0.7862
0.7455
PRODUCTO PROPRANOLOL CLORHIDRATO 40 mg GENFAR
Lote: 124577
Fab : Jun-16
Vence: Jan-18

Linealidad del Metodo dia 1

Nivel mg/mL Absorbancia contenido Real

0.00500 0.2032 0.0050443524
25 0.00500 0.2040 0.0050641465
0.00500 0.2043 0.0050718585
0.01000 0.3959 0.0099969838
50 0.01000 0.3973 0.0100324589
0.01000 0.3982 0.0100561089
0.01500 0.5823 0.0147881777
75 0.01500 0.5834 0.014816455
0.01500 0.5845 0.0148447322
0.02000 0.7818 0.0199174133
100 0.02000 0.7885 0.0200904186
0.02000 0.7895 0.020115354
0.02500 0.9833 0.025097805
125 0.02500 0.9826 0.025078268
0.02500 0.9790 0.0249854672
Promedio 0.5905

Linealidad del Metodo dia 2

Nivel mg/mL Absorbancia contenido Real
0.00500 0.2068 0.005136382
25 0.00500 0.2008 0.0049811142
0.00500 0.2019 0.0050093915
0.01000 0.4007 0.0101214036
50 0.01000 0.3921 0.0098990417
0.01000 0.3931 0.0099247482
0.01500 0.5844 0.0148416474
75 0.01500 0.5840 0.0148318789
0.01500 0.5838 0.01482828
0.02000 0.7828 0.0199441482
100 0.02000 0.7847 0.0199929907
0.02000 0.7854 0.0200091858
0.02500 0.9896 0.0252597565
125 0.02500 0.9805 0.0250250554
 125
0.02500 0.9801 0.0250142586
promedio 0.5900

Resumen
mg/mL Curva de regresi
1.5000
Estadsticas de la regresin

Absorbancia
1.0000
Coeficiente d 0.9998917992 f(x) = 38.9005333333x + 0.007002
0.5000
Coeficiente 0.9997836101
R^2 ajustado 0.9997669647 0.0000
0.00000 0.01000 0.02000 0.0300
Error tpico 0.0043469033
Observacione 15 mg/mL

ANLISIS DE VARIANZA
Grados de libertad Suma de cuadradosPromedio de los cuadrados
Regresin 1 1.1349386202 1.1349386202
Residuos 13 0.0002456424 1.889556820513E-05
Total 14 1.1351842626

Coeficientes Error tpico Estadstico t

Intercepcin 0.007002 0.0026321807 2.6601517577
mg/mL 38.9005333333 0.1587264658 245.0790619023

Anlisis de los residuales

Observacin Pronstico Absorbancia Residuos

1 0.2015046667 0.0017253333
2 0.2015046667 0.0024953333
3 0.2015046667 0.0027953333
4 0.3960073333 -0.0001173333
5 0.3960073333 0.0012626667
6 0.3960073333 0.0021826667
7 0.59051 -0.00824
8 0.59051 -0.00714
9 0.59051 -0.00604
10 0.7850126667 -0.0032126667
11 0.7850126667 0.0035173333
12 0.7850126667 0.0044873333
13 0.9795153333 0.0038046667
14 0.9795153333 0.0030446667
15 0.9795153333 -0.0005653333
% Recuperado Error Promedio CV global
100.887048678 100.89
101.2829301398 101.28
101.4371696703 101.44
99.9698376029 99.97
100.3245885232 100.32
100.5610891367 100.56
98.5878514091 98.59
98.7763663909 98.78 0.01
98.9648813727 98.96
99.5870665012 99.59
100.4520932018 100.45
100.5767701557 100.58
100.3912200004 100.39
100.3130719716 100.31
99.9418688347 99.94

% Recuperado Error Promedio CV global

102.7276404094 2.7276404094
99.6222845274 0.3777154726
100.1878294728 0.1878294728
101.2140364828 1.2140364828
98.9904165838 1.0095834162
99.2474824681 0.7525175319
98.9443161019 1.0556838981
98.8791927446 1.1208072554 0.0094427225
98.8551999287 1.1448000713
99.7207407611 0.2792592389
99.9649533511 0.0350466489
100.0459291047 0.0459291047
101.0390260288 1.0390260288
100.1002214194 0.1002214194
 100.0570343509 0.0570343509

mg/mL Curva de regresin ajustada

00
Absorbancia
00
f(x) = 38.9005333333x + 0.007002 Pronstico Absorbancia
00 Linear (Pronstico
Absorbancia)
00
0.00000 0.01000 0.02000 0.03000
mg/mL

F Valor crtico de F
60063.7465829334 3.27872979754E-25

Probabilidad Inferior 95% Superior 95% Inferior 95.0% Superior 95.0%

0.0196288997 0.0013155194 0.0126884806 0.0013155194 0.0126884806
3.27872979754E-25 38.5576256517 39.243441015 38.5576256517 39.243441015