非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.063801046384270538187993807014380340238145930.45
210.173878440388487138816560.12
单位质量响应值RSD%判断
379184.19381677.090.47数据可信
供试品溶液-2024112321批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1334891-3348917.9236.898.407.926.898.40
2268177-2681776.3446.34
3295596-2955966.9936.99
4297181-2971817.0317.03
5273849-2738496.4796.48
6277285-2772856.5606.56
10min1584912-58491213.83812.983.8513.8612.993.87
2553520-55352013.09513.11
3526548-52654812.45712.47
4554992-55499213.13013.15
5538109-53810912.73012.74
6533045-53304512.61112.63
15min1671863-67186315.89515.372.6415.9415.422.63
2654293-65429315.47915.52
3624857-62485714.78314.83
4655072-65507215.49715.54
5658216-65821615.57215.61
6634300-63430015.00615.05
20min1715138-71513816.91816.432.3617.0016.512.36
2714451-71445116.90216.98
3685630-68563016.22016.30
4680864-68086416.10816.19
5692752-69275216.38916.47
6678644-67864416.05516.13
30min1765518-76551818.11017.621.9818.2317.741.97
2753450-75345017.82517.94
3741223-74122317.53617.65
4737378-73737817.44517.56
5748785-74878517.71417.83
6722657-72265717.09617.21
45min1792625-79262518.75218.261.9618.9118.421.96
2778000-77800018.40618.56
3759032-75903217.95718.11
4778119-77811918.40818.56
5773358-77335818.29618.45
6750384-75038417.75217.90
60min1794290-79429018.79118.631.3618.9918.821.35
2805579-80557919.05819.25
3781952-78195218.49918.69
4781594-78159418.49118.69
5785703-78570318.58818.78
6776052-77605218.36018.55
极限1807729-80772919.10918.771.8119.3519.011.81
2812405-81240519.22019.46
3783266-78326618.53018.76
4794186-79418618.78919.02
5788489-78848918.65418.89
6775250-77525018.34118.57
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.063887228389357738864083881544388405138865620.12
210.173898656389382638962410.09
单位质量响应值RSD%判断
386338.17383111.210.60数据可信
供试品溶液-2024112321批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1177490-1774904.1525.7918.274.155.7918.29
2279372-2793726.5366.54
3239891-2398915.6125.61
4305992-3059927.1587.16
5259259-2592596.0656.07
6221748-2217485.1885.19
10min1474567-47456711.10212.226.6911.1112.236.71
2549748-54974812.86112.88
3517306-51730612.10212.11
4570112-57011213.33713.35
5526315-52631512.31212.33
6495144-49514411.58311.59
15min1613202-61320214.34514.685.3614.3814.725.38
2653946-65394615.29815.34
3610149-61014914.27414.31
4664769-66476915.55115.60
5647742-64774215.15315.19
6576047-57604713.47613.51
20min1676438-67643815.82416.132.4715.8916.202.48
2698183-69818316.33316.41
3661741-66174115.48115.55
4707068-70706816.54116.62
5699475-69947516.36316.44
6693577-69357716.22516.29
30min1744231-74423117.41017.232.4717.5117.342.47
2756355-75635517.69417.81
3711147-71114716.63616.74
4721688-72168816.88317.00
5753892-75389217.63617.75
6730753-73075317.09517.20
45min1766615-76661517.93417.715.2118.0717.865.19
2785723-78572318.38118.53
3729479-72947917.06517.21
4785797-78579718.38318.54
5785464-78546418.37518.53
6690296-69029616.14916.29
60min1740162-74016217.31517.673.4817.4917.863.47
2773965-77396518.10618.30
3717673-71767316.78916.97
4741981-74198117.35817.55
5787364-78736418.41918.61
6771192-77119218.04118.22
极限1748860-74886017.51917.424.8017.7417.654.75
2792941-79294118.55018.78
3763210-76321017.85418.07
4715542-71554216.73916.97
5755834-75583417.68217.91
6692577-69257716.20216.42
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.063916225391738739151573909989390418139125880.15
210.173928715393471339317140.11
单位质量响应值RSD%判断
388925.25386599.210.43数据可信
供试品溶液-2024112421批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1389079-3890799.0318.207.989.038.207.98
2317030-3170307.3587.36
3382829-3828298.8868.89
4354767-3547678.2348.23
5337003-3370037.8227.82
6338068-3380687.8477.85
10min1586385-58638513.61013.102.6213.6313.122.62
2555219-55521912.88712.90
3567778-56777813.17813.20
4576177-57617713.37313.39
5552715-55271512.82912.85
6549096-54909612.74512.76
15min1667492-66749215.49315.111.7615.5415.151.76
2647330-64733015.02515.07
3656375-65637515.23515.28
4645123-64512314.97415.02
5654909-65490915.20115.25
6634019-63401914.71614.76
20min1720458-72045816.72216.391.7316.8116.471.75
2712918-71291816.54716.63
3704366-70436616.34916.43
4710414-71041416.48916.57
5705074-70507416.36516.44
6684454-68445415.88615.96
30min1757682-75768217.58617.221.4617.7117.341.47
2749010-74901017.38517.50
3742998-74299817.24517.36
4738004-73800417.12917.25
5738511-73851117.14117.26
6726017-72601716.85116.96
45min1788350-78835018.29818.031.9718.4618.181.97
2770754-77075417.88918.04
3795961-79596118.47518.63
4778688-77868818.07418.23
5775446-77544617.99818.15
6751865-75186517.45117.60
60min1800708-80070818.58518.351.5618.7918.551.56
2799695-79969518.56118.75
3799142-79914218.54818.75
4785281-78528118.22718.42
5790430-79043018.34618.54
6768966-76896617.84818.04
极限1819001-81900119.00918.463.8919.2518.703.86
2807367-80736718.73918.97
3828340-82834019.22619.47
4785785-78578518.23818.47
5790826-79082618.35518.59
6741758-74175817.21617.45
非布司他片项目信息
介质体积(ml)900取样体积(ml)2补液体积(ml)2
对照品批号101278-202003对照品来源中检院对照品使用方法直接使用
对照品含量(%)100对照品水分(%)0对照品稀释倍数500
标示量(mg)20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%
110.063970461397459239704523969146396506639699430.09
210.173937559394071939391390.06
单位质量响应值RSD%判断
394626.54387329.301.32数据可信
供试品溶液-2024112421批-pH6.0
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1352140-3521408.1077.583.538.117.583.55
2324215-3242157.4647.46
3321016-3210167.3907.39
4328728-3287287.5687.57
5326493-3264937.5167.52
6322262-3222627.4197.42
10min1563622-56362212.97512.631.8712.9912.641.87
2534519-53451912.30512.32
3549740-54974012.65612.67
4549549-54954912.65112.67
5553771-55377112.74812.77
6540073-54007312.43312.45
15min1594646-59464613.68914.553.2513.7414.603.23
2627695-62769514.45014.49
3630451-63045114.51414.56
4644096-64409614.82814.87
5651612-65161215.00115.05
6644547-64454714.83814.88
20min1705386-70538616.23915.992.5616.3216.072.55
2691887-69188715.92816.00
3697442-69744216.05616.13
4711441-71144116.37816.46
5701134-70113416.14116.22
6661231-66123115.22215.30
30min1751041-75104117.29016.435.8417.4016.555.79
2736126-73612616.94717.06
3638766-63876614.70514.82
4733724-73372416.89117.01
5730994-73099416.82816.94
6692519-69251915.94316.05
45min1669259-66925915.40716.187.1515.5616.337.09
2752033-75203317.31317.46
3684399-68439915.75615.90
4685095-68509515.77215.92
5777271-77727117.89418.05
6649350-64935014.94915.10
60min1688182-68818215.84315.7214.4516.0315.9014.30
2745892-74589217.17117.36
3505426-50542611.63611.82
4731326-73132616.83617.02
5780056-78005617.95818.15
6645955-64595514.87115.05
极限1672287-67228715.47715.956.8515.7016.176.74
2775755-77575517.85918.08
3724387-72438716.67616.88
4654237-65423715.06115.29
5663886-66388615.28315.51
6667579-66757915.36815.58
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