布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.369682996722965559660696883967190.15
211.299673596808967720.06
单位质量响应值RSD%判断
8514.008571.480.48数据可信
供试品溶液-25061901批-pH4.3
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min153468-5346856.04956.605.7956.0556.605.79
258296-5829661.11061.11
356741-5674159.48059.48
453255-5325555.82655.83
552706-5270655.25055.25
649489-4948951.87851.88
15min163312-6331266.36864.137.8666.6864.457.85
266750-6675069.97270.31
364767-6476767.89368.22
459704-5970462.58662.90
559160-5916062.01662.32
653384-5338455.96156.25
30min166544-6654469.75666.756.1970.4467.426.20
268516-6851671.82372.55
365052-6505268.19268.90
463220-6322066.27266.93
561192-6119264.14664.80
657537-5753760.31460.91
45min165587-6558768.75368.996.4569.8270.036.44
270208-7020873.59774.72
371289-7128974.73075.82
463272-6327266.32667.35
564345-6434567.45168.46
660166-6016663.07064.00
60min170945-7094574.37073.028.7175.8274.448.66
278014-7801481.78083.32
375010-7501078.63180.13
464867-6486767.99869.39
566589-6658969.80371.19
662496-6249665.51366.80
90min168603-6860371.91573.288.3773.7875.118.33
276757-7675780.46282.45
376728-7672880.43282.37
467949-6794971.22973.00
567673-6767370.94072.71
661714-6171464.69366.34
120min171549-7154975.00372.929.2877.2775.169.21
278624-7862482.41984.86
371989-7198975.46477.85
468386-6838671.68773.86
567865-6786571.14173.31
658975-5897561.82263.83
极限1-0.0000.00-2.682.647.38
2-0.0002.90
3-0.0002.80
4-0.0002.57
5-0.0002.56
6-0.0002.35
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.369697597252969779723497028970930.15
211.299698696947969660.03
单位质量响应值RSD%判断
8546.928588.660.35数据可信
供试品溶液-2810778批-pH4.3
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min169011-6901172.13072.622.7272.1372.622.72
268719-6871971.82571.83
372321-7232175.59075.59
467455-6745570.50470.50
571234-7123474.45474.45
668162-6816271.24371.24
15min176571-7657180.03280.500.8780.4380.910.88
276854-7685480.32880.73
378268-7826881.80682.23
476932-7693280.40980.80
577131-7713180.61781.03
676378-7637879.83080.23
30min181836-8183685.53584.052.1686.3884.902.14
281301-8130184.97685.82
378010-7801081.53682.41
478416-7841681.96082.80
581095-8109584.76085.62
681837-8183785.53686.38
45min185599-8559989.46889.272.3390.7990.582.31
286087-8608789.97891.30
387712-8771291.67793.00
481717-8171785.41186.70
585385-8538589.24490.58
685936-8593689.82091.13
60min187912-8791291.88691.981.4093.7093.791.39
288099-8809992.08193.90
388273-8827392.26394.10
486128-8612890.02191.79
589944-8994494.00995.84
687656-8765691.61893.43
90min189657-8965793.70992.162.2896.0494.482.22
284599-8459988.42390.75
387909-8790991.88294.23
489259-8925993.29395.56
590051-9005194.12196.47
687567-8756791.52593.85
120min190929-9092995.03994.211.9197.8997.041.86
290298-9029894.37997.20
390864-9086494.97197.83
490917-9091795.02697.81
591121-9112195.24098.11
686670-8667090.58793.42
极限1-0.0000.00-3.383.361.09
2-0.0003.34
3-0.0003.39
4-0.0003.31
5-0.0003.40
6-0.0003.33
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.369604096030958109604396015959880.11
211.299628096679964800.30
单位质量响应值RSD%判断
8449.658545.620.80数据可信
供试品溶液-25061901批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min141949-4194944.20842.682.7744.2142.682.76
240546-4054642.73042.73
341144-4114443.36043.36
440096-4009642.25542.26
540660-4066042.85042.85
638616-3861640.69640.70
15min151552-5155254.32853.542.4554.5753.782.45
249512-4951252.17952.42
351721-5172154.50754.75
450391-5039153.10553.34
552331-5233155.14955.39
649329-4932951.98652.21
30min158236-5823661.37259.772.9261.9260.312.91
255480-5548058.46859.00
357815-5781560.92961.47
454919-5491957.87758.41
558558-5855861.71262.26
655305-5530558.28458.80
45min163001-6300166.39464.283.3667.2865.143.35
260312-6031263.56064.41
362060-6206065.40266.28
458880-5888062.05162.90
563179-6317966.58267.47
658533-5853361.68562.52
60min165923-6592369.47366.654.1370.7367.884.11
262518-6251865.88567.09
364907-6490768.40369.65
460295-6029563.54264.74
565624-6562469.15870.42
660203-6020363.44564.63
90min168832-6883272.53969.224.2174.1870.814.18
265265-6526568.78070.35
367088-6708870.70172.33
462425-6242565.78767.34
567989-6798971.65173.29
662495-6249565.86167.39
120min171512-7151275.36370.945.0977.4172.925.04
267006-6700670.61572.57
368885-6888572.59574.61
462965-6296566.35668.27
569818-6981873.57875.62
663677-6367767.10669.01
极限172385-7238576.28371.765.2678.7574.135.20
267912-6791271.57073.92
369810-6981073.57075.99
463525-6352566.94669.23
570685-7068574.49276.94
664218-6421867.67769.95
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.369672096512966889669596614966460.09
211.299636596636965000.20
单位质量响应值RSD%判断
8507.578547.390.34数据可信
供试品溶液-2810778批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min139359-3935941.33239.007.3341.3339.007.33
238612-3861240.54840.55
339370-3937041.34441.34
434087-3408735.79635.80
538120-3812040.03140.03
633308-3330834.97834.98
15min145391-4539147.66746.144.0547.9046.364.06
245163-4516347.42747.65
345255-4525547.52447.75
442476-4247644.60644.80
544281-4428146.50146.72
641072-4107243.13143.33
30min157048-5704859.90857.855.9960.4058.335.99
257185-5718560.05260.54
356908-5690859.76160.26
454191-5419156.90857.35
556464-5646459.29559.78
648753-4875351.19751.63
45min164576-6457667.81467.601.5768.6468.391.61
265585-6558568.87369.70
364757-6475768.00468.83
463421-6342166.60167.36
564972-6497268.23069.04
662913-6291366.06766.79
60min170383-7038373.91273.521.6275.1274.691.65
271201-7120174.77175.98
370194-7019473.71474.92
468278-6827871.70172.83
570934-7093474.49175.68
669051-6905172.51373.60
90min177400-7740081.28180.930.8582.9082.510.89
277962-7796281.87183.49
376503-7650380.33981.95
476987-7698780.84782.38
577393-7739381.27482.88
676173-7617379.99281.48
120min181788-8178885.88985.700.6987.9687.720.73
282223-8222386.34688.42
381213-8121385.28587.34
481281-8128185.35687.34
582226-8222686.34988.40
680892-8089284.94886.88
极限183647-8364787.84187.610.5890.3890.120.62
284018-8401888.23190.79
383093-8309387.25989.79
483277-8327787.45389.91
583791-8379187.99290.53
682737-8273786.88589.29
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.369638696202965409633896184963300.16
211.299647696793966340.24
单位质量响应值RSD%判断
8479.758559.260.66数据可信
供试品溶液-25061901批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min12182-21822.2942.9541.302.292.9541.38
24925-49255.1775.18
32594-25942.7272.73
42452-24522.5772.58
53150-31503.3113.31
61555-15551.6351.63
30min15454-54545.7336.5823.985.756.6023.97
27650-76508.0418.07
36414-64146.7426.76
47948-79488.3548.37
56234-62346.5536.57
63850-38504.0474.06
45min15504-55045.7857.8629.035.837.9128.97
29215-92159.6869.76
39768-976810.26810.32
48982-89829.4419.50
56853-68537.2037.26
64526-45264.7574.79
60min18754-87549.2029.8723.469.289.9723.47
211733-1173312.33312.46
311207-1120711.78011.89
410869-1086911.42511.54
57403-74037.7827.88
66398-63986.7256.78
90min19735-973510.23311.4024.2710.3611.5624.23
212785-1278513.43913.63
313747-1374714.45014.63
412917-1291713.57813.75
58277-82778.7008.84
67630-76308.0208.12
120min19467-94679.95112.9423.5310.1413.1623.51
214946-1494615.71015.98
315613-1561316.41116.67
413349-1334914.03214.28
512032-1203212.64712.83
68456-84568.8889.03
极限114617-1461715.36514.9020.2515.6015.1920.25
216206-1620617.03517.39
317548-1754818.44518.79
414674-1467415.42415.75
512645-1264513.29213.55
69389-93899.86910.06
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.369635396302966609662896546964980.17
211.299637396234963040.11
单位质量响应值RSD%判断
8494.548530.030.30数据可信
供试品溶液-2810778批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min12298-22982.4182.4815.742.422.4815.68
21710-17101.7991.80
32352-23522.4742.47
42702-27022.8432.84
52741-27412.8842.88
62351-23512.4732.47
15min13702-37023.8954.7619.233.914.7819.19
24364-43644.5914.60
34314-43144.5384.55
46003-60036.3156.33
55029-50295.2915.31
63750-37503.9453.96
30min16692-66927.0407.413.737.087.463.72
27018-70187.3837.42
36829-68297.1847.22
47208-72087.5837.63
57120-71207.4907.54
67420-74207.8067.84
45min19671-967110.1749.614.3410.259.694.29
29543-954310.03910.12
38907-89079.3709.45
49138-91389.6139.71
58681-86819.1339.22
68863-88639.3249.40
60min19859-985910.37211.305.7410.5011.435.69
211433-1143312.02812.16
310778-1077811.33911.47
411190-1119011.77211.92
510146-1014610.67410.81
611027-1102711.60111.73
90min112604-1260413.26013.055.2713.4513.255.18
212375-1237513.01913.22
313346-1334614.04014.23
412708-1270813.36913.58
511978-1197812.60112.80
611440-1144012.03512.23
120min113014-1301413.69114.404.5213.9514.674.47
214641-1464115.40315.67
314101-1410114.83415.11
413823-1382314.54214.83
513393-1339314.09014.36
613165-1316513.85014.11
极限115450-1545016.25415.236.6216.5915.586.48
215585-1558516.39616.75
314334-1433415.08015.43
414683-1468315.44715.81
513377-1337714.07314.42
613414-1341414.11214.45
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.369648496808960799642496492964570.27
211.299309493278931860.14
单位质量响应值RSD%判断
8490.938253.852.01数据不可信!(响应值差异过大,请重新称样测定!)
供试品溶液-25062302批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min12826-28263.0233.3498.933.023.3498.99
2-0.0000.00
35659-56596.0546.05
47970-79708.5268.53
51037-10371.1091.11
61237-12371.3231.32
30min111843-1184312.67010.3520.5712.6910.3720.65
210159-1015910.86810.87
310401-1040111.12711.16
411135-1113511.91211.96
56726-67267.1957.20
67800-78008.3448.35
45min111351-1135112.14312.194.7712.2312.274.77
212327-1232713.18713.25
310903-1090311.66411.76
411707-1170712.52412.64
510938-1093811.70111.75
611156-1115611.93511.99
60min111641-1164112.45412.835.3512.6112.985.38
212911-1291113.81213.95
312594-1259413.47313.63
412029-1202912.86913.05
511527-1152712.33212.44
611276-1127612.06312.18
90min112954-1295413.85813.615.2214.0813.825.29
213473-1347314.41314.62
312953-1295313.85714.09
413066-1306613.97814.23
511650-1165012.46312.64
612214-1221413.06713.25
120min113871-1387114.83914.706.2015.1415.006.20
215118-1511816.17316.46
313875-1387514.84315.16
413942-1394214.91515.25
512858-1285813.75614.00
612806-1280613.70013.96
极限114411-1441115.41715.124.9015.8015.494.89
214764-1476415.79516.17
314123-1412315.10915.50
414427-1442715.43415.85
514282-1428215.27915.60
612788-1278813.68114.02
布瑞哌唑口服混悬液项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号430038-202402对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.5对照品水分(%)0对照品稀释倍数25000
标示量(mg)2供试品稀释倍数5系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.369292793213932719332993390932260.20
211.299439994615945070.17
单位质量响应值RSD%判断
8206.518370.861.41数据可信
供试品溶液-25062302批-pH6.8
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
10min1-0.0000.00-0.000.00-
2-0.0000.00
3-0.0000.00
4-0.0000.00
5-0.0000.00
6-0.0000.00
15min12159-21592.3333.3591.982.333.3591.99
26091-60916.5816.58
33957-39574.2764.28
4-0.0000.00
56402-64026.9176.92
6-0.0000.00
30min18667-86679.3657.8358.839.387.8558.88
210955-1095511.83711.87
39123-91239.8579.88
44286-42864.6314.63
510467-1046711.31011.35
6-0.0000.00
45min18819-88199.52910.5631.079.5910.6231.20
212140-1214013.11713.22
312498-1249813.50413.58
49966-996610.76810.79
510976-1097611.86011.96
64236-42364.5774.58
60min19478-947810.24111.7318.7310.3611.8518.97
212620-1262013.63613.81
312181-1218113.16213.32
411085-1108511.97712.06
512337-1233713.33013.50
67443-74438.0428.07
90min111996-1199612.96213.1913.1613.1413.3813.45
214234-1423415.38015.63
311741-1174112.68612.91
411550-1155012.48012.63
513851-1385114.96615.21
69884-988410.68010.75
120min111963-1196312.92613.9412.9513.1714.2013.22
215193-1519316.41616.75
313745-1374514.85115.15
412573-1257313.58513.81
513572-1357214.66414.99
610345-1034511.17811.31
极限113844-1384414.95815.1510.4215.2815.4810.73
216236-1623617.54317.97
314277-1427715.42615.81
413395-1339514.47314.77
514564-1456415.73616.14
611794-1179412.74312.93
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