普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.525053550329505585055050423504790.20
216.525037850408503930.05
单位质量响应值RSD%判断
3055.633050.420.13数据可信
中间条件18月-供试品溶液-2022100911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%
2min147650-4765093.08391.181.9193.0891.181.91
245995-4599589.85089.85
347851-4785193.47693.48
446697-4669791.22191.22
545797-4579789.46389.46
646067-4606789.99189.99
5min153125-53125103.778101.911.71103.78101.911.71
252409-52409102.380102.38
353086-53086103.702103.70
451830-51830101.248101.25
550806-5080699.24899.25
651752-51752101.096101.10
10min153043-53043103.618102.171.61103.62102.171.61
252366-52366102.296102.30
353329-53329104.177104.18
451965-51965101.512101.51
550978-5097899.58499.58
652119-52119101.813101.81
15min153169-53169103.864102.271.60103.86102.261.60
252466-52466102.491102.49
353257-53257104.036104.04
452176-52176101.924101.92
550988-5098899.60499.60
652049-52049101.676101.68
30min153256-53256104.034102.221.72104.03102.221.72
252253-52253102.075102.07
353296-53296104.112104.11
452258-52258102.085102.08
550865-5086599.36399.36
652041-52041101.661101.66
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.525038350075501465027850218502200.24
216.525038050342503610.06
单位质量响应值RSD%判断
3039.953048.490.20数据可信
长期18月-供试品溶液-2022100911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%
2min143272-4327284.77588.502.6784.7888.502.67
246771-4677191.63091.63
345626-4562689.38789.39
445831-4583189.78989.79
544511-4451187.20387.20
645043-4504388.24588.24
5min150956-5095699.829101.621.0499.83101.621.04
252017-52017101.908101.91
352492-52492102.838102.84
452250-52250102.364102.36
551844-51844101.569101.57
651651-51651101.191101.19
10min151175-51175100.258102.101.06100.26102.101.06
252155-52155102.178102.18
352811-52811103.463103.46
452477-52477102.809102.81
552102-52102102.074102.07
651961-51961101.798101.80
15min151153-51153100.215102.181.12100.22102.181.12
252225-52225102.315102.32
352907-52907103.652103.65
452413-52413102.684102.68
552289-52289102.441102.44
651957-51957101.790101.79
30min151260-51260100.425102.581.20100.42102.581.20
252164-52164102.196102.20
353123-53123104.075104.07
452519-52519102.891102.89
552649-52649103.146103.15
652449-52449102.754102.75
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.525027550404503685048350469504000.17
216.525041050214503120.28
单位质量响应值RSD%判断
3050.853045.520.13数据可信
中间条件18月-供试品溶液-2022101011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%
2min146348-4634890.68389.842.1390.6889.842.13
245080-4508088.20288.20
347254-4725492.45692.46
444794-4479487.64387.64
545377-4537788.78488.78
646645-4664591.26591.26
5min151169-51169100.116100.541.12100.12100.541.12
251117-51117100.014100.01
352377-52377102.480102.48
450877-5087799.54599.54
551764-51764101.280101.28
651022-5102299.82899.83
10min151061-5106199.905100.751.0699.90100.751.06
251372-51372100.513100.51
352477-52477102.675102.68
451172-51172100.122100.12
551762-51762101.276101.28
651125-51125100.030100.03
15min151247-51247100.269100.851.12100.27100.851.12
251416-51416100.599100.60
352580-52580102.877102.88
451037-5103799.85899.86
551821-51821101.392101.39
651171-51171100.120100.12
30min151381-51381100.531100.791.07100.53100.791.07
251392-51392100.552100.55
352509-52509102.738102.74
450929-5092999.64699.65
551676-51676101.108101.11
651186-51186100.149100.15
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.525025150441504105035650398503710.15
216.525003850062500500.04
单位质量响应值RSD%判断
3049.093029.660.46数据可信
长期18月-供试品溶液-2022101011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%
2min149687-4968797.49995.471.2897.5095.471.28
248326-4832694.82894.83
349008-4900896.16796.17
448612-4861295.39095.39
548385-4838594.94494.94
647908-4790894.00894.01
5min152317-52317102.660101.580.89102.66101.580.89
251637-51637101.325101.33
351778-51778101.602101.60
452013-52013102.063102.06
551878-51878101.798101.80
650963-50963100.003100.00
10min152219-52219102.467101.421.08102.47101.421.08
251426-51426100.911100.91
351581-51581101.216101.22
452040-52040102.116102.12
552101-52101102.236102.24
650743-5074399.57199.57
15min152121-52121102.275101.360.99102.28101.360.99
251502-51502101.061101.06
351691-51691101.431101.43
451942-51942101.924101.92
551944-51944101.928101.93
650718-5071899.52299.52
30min152117-52117102.267101.150.92102.27101.150.92
251403-51403100.866100.87
351591-51591101.235101.24
451749-51749101.545101.55
551718-51718101.484101.48
650711-5071199.50899.51
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.525003450071500125005349996500330.07
216.525013750223501800.13
单位质量响应值RSD%判断
3028.633037.530.21数据可信
中间条件18月-供试品溶液-2022101111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%
2min144562-4456287.62384.572.5687.6284.572.56
242120-4212082.82182.82
343735-4373585.99786.00
442780-4278084.11984.12
543319-4331985.17985.18
641535-4153581.67181.67
5min150241-5024198.790100.641.0898.79100.651.08
251190-51190100.656100.66
351475-51475101.216101.22
451907-51907102.066102.07
551129-51129100.536100.54
651159-51159100.595100.60
10min151026-51026100.334101.060.58100.33101.060.58
251198-51198100.672100.67
351461-51461101.189101.19
451881-51881102.015102.01
551323-51323100.918100.92
651494-51494101.254101.25
15min150900-50900100.086101.350.87100.09101.350.87
251280-51280100.833100.83
351386-51386101.041101.04
452166-52166102.575102.58
551747-51747101.751101.75
651765-51765101.787101.79
30min151047-51047100.375101.170.77100.37101.170.77
251157-51157100.591100.59
351589-51589101.441101.44
452090-52090102.426102.43
551198-51198100.672100.67
651633-51633101.527101.53
普瑞巴林口崩片项目信息
介质体积(ml)900取样体积(ml)0补液体积(ml)0
对照品批号101106-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.4对照品水分(%)0对照品稀释倍数100
标示量(mg)150供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.525011550250504385043950208502900.29
216.525032950053501910.39
单位质量响应值RSD%判断
3044.193038.200.14数据可信
长期18月-供试品溶液-2022101111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%
2min144150-4415086.58189.494.1886.5889.494.18
243496-4349685.29985.30
345060-4506088.36688.37
447293-4729392.74592.75
548492-4849295.09695.10
645300-4530088.83788.84
5min150441-5044198.91999.070.8298.9299.070.82
250084-5008498.21898.22
350070-5007098.19198.19
450990-5099099.995100.00
550999-50999100.013100.01
650525-5052599.08399.08
10min150787-5078799.597100.220.6999.60100.220.69
250792-5079299.60799.61
350805-5080599.63299.63
451367-51367100.735100.73
551578-51578101.148101.15
651305-51305100.613100.61
15min150836-5083699.693100.100.6099.69100.100.60
250714-5071499.45499.45
350880-5088099.77999.78
451546-51546101.086101.09
551094-51094100.199100.20
651198-51198100.403100.40
30min151089-51089100.18999.990.42100.19100.000.42
250756-5075699.53699.54
350886-5088699.79199.79
450776-5077699.57699.58
551164-51164100.336100.34
651265-51265100.534100.53
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