培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8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%
110.234311714269184284474278614290654286920.38
210.204263954260964262460.05
单位质量响应值RSD%判断
41905.3841788.820.20数据可信
供试品溶液-2023041511批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1334584-33458489.76871.6533.4089.7771.6533.41
2351509-35150994.30994.31
3111754-11175429.98329.98
4225651-22565160.54260.54
5264422-26442270.94470.94
6314432-31443284.36284.36
10min1367676-36767698.64797.851.8198.8097.971.84
2371579-37157999.69499.85
3354987-35498795.24395.29
4371161-37116199.58299.68
5362726-36272697.31997.44
6360119-36011996.61996.76
15min1367382-36738298.56898.661.2698.8898.941.27
2372824-372824100.028100.35
3365174-36517497.97698.18
4373358-373358100.171100.44
5366263-36626398.26898.55
6361385-36138596.95997.26
20min1366646-36664698.37198.611.2798.8599.061.27
2372433-37243399.923100.41
3365931-36593198.17998.55
4373241-373241100.140100.57
5366290-36629098.27598.72
6360756-36075696.79097.25
30min1366333-36633398.28798.401.1498.9399.011.14
2371737-37173799.737100.39
3365707-36570798.11998.65
4371103-37110399.566100.17
5365189-36518997.98098.59
6360478-36047896.71697.34
极限1365214-36521497.98698.211.2298.7998.981.22
2370998-37099899.538100.36
3364855-36485597.89098.59
4371091-37109199.563100.33
5364779-36477997.87098.64
6359318-35931896.40597.19
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8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%
110.234253274250784244414251274251504250250.08
210.204262634262614262620.01
单位质量响应值RSD%判断
41546.9241790.390.42数据可信
供试品溶液-2023041511批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1270191-27019172.80380.8315.7372.8080.8315.73
2333630-33363089.89689.90
3347491-34749193.63193.63
4227130-22713061.20061.20
5336344-33634490.62890.63
6285141-28514176.83176.83
10min1362355-36235597.63698.881.0697.7699.011.07
2366556-36655698.76898.92
3369846-36984699.65599.81
4362680-36268097.72497.83
5368448-36844899.27899.43
6371894-371894100.207100.33
15min1364237-36423798.14399.311.0098.4399.611.01
2367541-36754199.03499.35
3371002-37100299.966100.29
4364691-36469198.26698.53
5370433-37043399.813100.13
6373423-373423100.619100.91
20min1364107-36410798.10899.170.8698.5699.640.86
2367237-36723798.95299.43
3370135-37013599.733100.22
4365428-36542898.46498.89
5368773-36877399.36699.85
6372645-372645100.409100.87
30min1363385-36338597.91498.970.9298.5399.600.92
2366539-36653998.76499.41
3368540-36854099.30399.96
4364781-36478198.29098.88
5367732-36773299.08599.73
6372953-372953100.492101.12
极限1362891-36289197.78198.900.9598.5699.700.95
2365957-36595798.60799.42
3368445-36844599.277100.10
4364295-36429598.15998.92
5368085-36808599.18099.99
6372606-372606100.398101.20
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8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%
110.234276894277374277094280494274824277330.05
210.204263134272444267780.16
单位质量响应值RSD%判断
41811.6341840.980.05数据可信
供试品溶液-2023041511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%
5min1309807-30980783.16281.7212.8183.1681.7212.81
2322403-32240386.54386.54
3335646-33564690.09890.10
4227715-22771561.12661.13
5307217-30721782.46782.47
6323808-32380886.92086.92
10min1367492-36749298.64696.301.8398.7996.441.84
2353830-35383094.97995.12
3360768-36076896.84296.99
4349779-34977993.89293.99
5363744-36374497.64097.78
6356860-35686095.79295.94
15min1375467-375467100.78797.731.73101.0998.021.73
2358616-35861696.26496.57
3362819-36281997.39297.70
4359529-35952996.50996.77
5366735-36673598.44398.74
6361226-36122696.96497.27
20min1374923-374923100.64198.081.44101.1198.541.44
2362797-36279797.38697.85
3363628-36362897.60998.08
4360881-36088196.87297.29
5367913-36791398.75999.22
6362213-36221397.22997.70
30min1375163-375163100.70698.431.28101.3499.051.28
2365016-36501697.98298.61
3363934-36393497.69198.33
4362789-36278997.38497.96
5368974-36897499.04499.67
6364163-36416397.75398.38
极限1373763-373763100.33098.591.04101.1499.381.05
2366003-36600398.24799.04
3364615-36461597.87498.67
4363689-36368997.62698.37
5369812-36981299.269100.06
6365880-36588098.21499.00
培哚普利叔丁胺片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号101072-202303对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数1000
标示量(mg)8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%
110.234268344270304272164267344265774268780.06
210.204275794278894277340.06
单位质量响应值RSD%判断
41728.0541934.710.35数据可信
供试品溶液-2023041511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%
5min1324347-32434787.05587.285.5787.0587.285.57
2337400-33740090.55890.56
3334568-33456889.79889.80
4298123-29812380.01680.02
5346318-34631892.95292.95
6310333-31033383.29483.29
10min1356468-35646895.67697.592.0795.8297.742.06
2359615-35961596.52196.67
3354726-35472695.20995.36
4369664-36966499.21899.35
5370158-37015899.35199.51
6371064-37106499.59499.73
15min1359951-35995196.61198.352.0396.9298.662.03
2363405-36340597.53897.85
3356876-35687695.78696.09
4371183-37118399.62699.92
5371456-37145699.699100.02
6375713-375713100.842101.15
20min1361469-36146997.01998.611.8097.4899.081.80
2365692-36569298.15298.63
3358615-35861596.25296.72
4371111-37111199.606100.07
5371818-37181899.796100.28
6375746-375746100.850101.32
30min1362965-36296597.42098.801.6498.0599.441.64
2367480-36748098.63299.27
3359911-35991196.60097.23
4370713-37071399.500100.13
5370830-37083099.531100.18
6376701-376701101.107101.75
极限1365643-36564398.13998.911.6198.9399.711.61
2369753-36975399.242100.04
3359123-35912396.38997.18
4370102-37010299.336100.13
5369357-36935799.13699.95
6377161-377161101.230102.04
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