依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D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)10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%
110.433556913584523564053565543563223566850.30
210.493544833544733544780.01
单位质量响应值RSD%判断
34197.9933791.990.85数据可信
供试品溶液-2024012321批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1150962-15096244.40950.4410.6244.4150.4410.61
2152256-15225644.78944.79
3173199-17319950.95050.95
4199584-19958458.71258.71
5179832-17983252.90152.90
6173004-17300450.89350.89
10min1271657-27165779.91479.183.7480.0579.343.73
2273489-27348980.45380.59
3278876-27887682.03782.19
4270061-27006179.44479.62
5271342-27134279.82179.98
6249639-24963973.43773.59
15min1319751-31975194.06293.303.9194.4393.683.90
2321846-32184694.67895.05
3332565-33256597.83198.23
4319196-31919693.89894.31
5314582-31458292.54192.94
6295001-29500186.78187.15
20min1329461-32946196.91896.582.1697.5797.252.16
2330726-33072697.29097.95
3339187-33918799.779100.47
4327994-32799496.48697.18
5324874-32487495.56996.24
6317685-31768593.45494.09
30min1332553-33255397.82897.891.5098.7798.851.51
2333663-33366398.15499.11
3341962-341962100.595101.59
4331053-33105397.38698.37
5327384-32738496.30797.27
6330076-33007697.09998.01
45min1332550-33255097.82798.091.4199.0799.351.41
2333125-33312597.99699.24
3342096-342096100.635101.93
4332945-33294597.94399.22
5327724-32772496.40797.66
6332292-33229297.75198.96
60min1332875-33287597.92298.021.3899.4699.561.38
2332916-33291697.93499.47
3341250-341250100.386101.98
4332736-33273697.88199.45
5326864-32686496.15497.69
6332605-33260597.84399.34
极限1335384-33538498.66099.070.99100.49100.920.98
2335743-33574398.766100.60
3341695-341695100.517102.41
4336431-33643198.968100.83
5332176-33217697.71799.55
6339305-33930599.814101.61
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D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)10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%
110.433553753569123556653553883551933557070.20
210.493552823553943553380.03
单位质量响应值RSD%判断
34104.2233873.980.48数据可信
供试品溶液-2024012321批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1138846-13884640.85145.3623.6940.8545.3623.69
2125117-12511736.81136.81
3119687-11968735.21435.21
4143257-14325742.14842.15
5188129-18812955.35055.35
6210087-21008761.81161.81
10min1268664-26866479.04579.986.8579.1780.126.87
2276566-27656681.37081.48
3251568-25156874.01574.12
4250899-25089973.81873.94
5297241-29724187.45387.62
6286216-28621684.20984.39
15min1321006-32100694.44593.413.6094.8093.793.62
2325912-32591295.88896.24
3308297-30829790.70691.03
4299242-29924288.04288.39
5329189-32918996.85297.28
6321340-32134094.54394.98
20min1336613-33661399.03796.692.4899.6897.352.50
2331660-33166097.57998.22
3322860-32286094.99095.59
4315262-31526292.75593.37
5335252-33525298.63699.36
6330217-33021797.15597.88
30min1341065-341065100.34797.632.07101.2998.582.08
2333372-33337298.08399.02
3326433-32643396.04296.93
4321638-32163894.63195.52
5335275-33527598.64399.66
6333227-33322798.04199.05
45min1342160-342160100.66997.682.07101.9198.922.09
2332835-33283597.92599.15
3326508-32650896.06497.24
4322533-32253394.89496.07
5335453-33545398.695100.01
6332618-33261897.86199.17
60min1342015-342015100.62697.652.07102.1799.182.08
2332507-33250797.82999.35
3325937-32593795.89697.36
4322757-32275794.96096.42
5335433-33543398.690100.30
6332794-33279497.91399.51
极限1344134-344134101.25098.742.08103.09100.562.10
2334052-33405298.283100.10
3330543-33054397.25199.00
4325400-32540095.73897.48
5341108-341108100.359102.26
6338353-33835399.549101.44
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D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)10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%
110.433556703557853556223559693561393558370.07
210.493546153540493543320.12
单位质量响应值RSD%判断
34116.6833778.070.71数据可信
供试品溶液-2024012421批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1145710-14571042.92341.6910.4442.9241.6910.44
2120552-12055235.51235.51
3155822-15582245.90245.90
4132864-13286439.13939.14
5135076-13507639.79139.79
6159182-15918246.89246.89
10min1301513-30151388.82084.133.7988.9584.263.80
2280386-28038682.59682.70
3293972-29397286.59986.74
4271702-27170280.03880.16
5279234-27923482.25782.38
6286798-28679884.48584.63
15min1322176-32217694.90794.931.5195.3095.311.50
2321577-32157794.73095.08
3315940-31594093.07093.47
4318311-31831193.76894.13
5327582-32758296.49996.87
6327996-32799696.62197.02
20min1326132-32613296.07297.222.4396.7597.882.41
2331788-33178897.73898.38
3317480-31748093.52494.20
4328259-32825996.69997.34
5336444-33644499.11099.77
6340000-340000100.158100.84
30min1327464-32746496.46597.622.4097.4398.572.38
2334786-33478698.62299.55
3317424-31742493.50794.46
4332415-33241597.92398.85
5339197-33919799.921100.87
6336992-33699299.271100.26
45min1329683-32968397.11897.692.3198.3898.942.29
2334180-33418098.44399.67
3317295-31729593.46994.71
4333145-33314598.13899.36
5338477-33847799.709100.96
6336901-33690199.245100.53
60min1330137-33013797.25297.672.3198.8099.212.29
2333928-33392898.36999.89
3317124-31712493.41994.94
4332993-33299398.09399.61
5338421-33842199.692101.24
6336827-33682799.223100.80
极限1331948-33194897.78698.480.5899.63100.310.59
2333555-33355598.259100.08
3334440-33444098.520100.32
4332754-33275498.02399.83
5336651-33665199.171101.02
6336471-33647199.118101.00
依折麦布片项目信息
介质体积(ml)500取样体积(ml)1.5补液体积(ml)1.5
对照品批号ZT-705-231101-1-D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)10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%
110.433554773559363553603551913552063554340.09
210.493543683546273544980.06
单位质量响应值RSD%判断
34078.0433793.900.60数据可信
供试品溶液-2024012421批-pH4.5(内含%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1174475-17447551.41443.719.8551.4143.719.85
2132422-13242239.02239.02
3145503-14550342.87642.88
4141243-14124341.62141.62
5142222-14222241.91041.91
6154199-15419945.43945.44
10min1299921-29992188.38083.174.2888.5383.304.28
2267535-26753578.83778.95
3277074-27707481.64881.78
4288227-28822784.93485.06
5272366-27236680.26080.39
6288395-28839584.98485.12
15min1323152-32315295.22694.191.4595.6594.571.46
2316438-31643893.24793.60
3317039-31703993.42493.80
4325402-32540295.88996.27
5313533-31353392.39192.76
6322283-32228394.97095.36
20min1326203-32620396.12596.201.1396.8396.861.13
2325538-32553895.92996.56
3324674-32467495.67496.33
4330245-33024597.31697.98
5321142-32114294.63395.28
6330994-33099497.53798.21
30min1330545-33054597.40496.950.7798.4097.900.78
2328726-32872696.86897.79
3327542-32754296.51997.46
4330739-33073997.46198.42
5324850-32485095.72696.65
6331585-33158597.71198.68
45min1329261-32926197.02696.910.5998.3198.150.61
2328039-32803996.66697.88
3327847-32784796.60997.84
4329983-32998397.23998.49
5326226-32622696.13297.35
6331818-33181897.77999.04
60min1329471-32947197.08896.710.5698.6698.240.57
2327284-32728496.44397.95
3326643-32664396.25497.77
4327724-32772496.57398.12
5326698-32669896.27197.77
6331230-33123097.60699.16
极限1335476-33547698.85797.450.84100.7399.280.85
2326982-32698296.35498.15
3330018-33001897.24999.06
4330706-33070697.45299.28
5329840-32984097.19798.99
6331234-33123497.60799.46
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