盐酸达伯西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.122037942037952038682038112036682037870.04
215.932039852041012040430.05
单位质量响应值RSD%判断
12641.8712808.730.93数据可信
供试品溶液-2024042421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%
5min132807-3280717.27522.7219.5217.2822.7219.51
252756-5275627.78027.78
347347-4734724.93224.93
435035-3503518.44818.45
550964-5096426.83626.84
639925-3992521.02321.02
10min1124842-12484265.73870.394.5565.8370.514.58
2140933-14093374.21174.37
3138099-13809972.71972.86
4128199-12819967.50667.61
5135638-13563871.42371.57
6134296-13429670.71770.83
15min1178710-17871094.10498.212.3294.5698.732.35
2189147-18914799.600100.17
3188398-18839899.20599.75
4186324-18632498.11398.59
5191066-191066100.610101.16
6185380-18538097.61698.13
20min1191187-191187100.674100.831.13101.66101.891.09
2191895-191895101.047102.17
3189094-18909499.572100.67
4195428-195428102.907103.93
5190613-190613100.371101.48
6190636-190636100.384101.44
30min1187304-18730498.629101.072.25100.17102.692.24
2191870-191870101.033102.71
3197183-197183103.831105.48
4195868-195868103.139104.73
5192716-192716101.479103.14
6186649-18664998.28499.89
45min1188125-18812599.061100.461.96101.15102.641.93
2187822-18782298.902101.14
3192567-192567101.400103.62
4196078-196078103.249105.42
5193302-193302101.787104.01
6186807-18680798.367100.52
极限1181835-18183595.74999.932.7298.39102.672.70
2192423-192423101.325104.12
3190304-190304100.209103.00
4193478-193478101.880104.62
5195203-195203102.788105.58
6185360-18536097.605100.31
盐酸达伯西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.122027922028572028772028052027212028100.04
215.932034912038452036680.13
单位质量响应值RSD%判断
12581.2712785.191.14数据可信
供试品溶液-29003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%
5min153547-5354728.29127.3111.0128.2927.3111.02
258598-5859830.95930.96
346294-4629424.45924.46
450540-5054026.70226.70
544335-4433523.42423.42
656807-5680730.01330.01
10min1141579-14157974.80071.726.4074.9671.876.41
2142741-14274175.41475.59
3134278-13427870.94371.08
4134336-13433670.97471.12
5119813-11981363.30163.43
6141724-14172474.87775.04
15min1193651-193651102.31299.423.86102.8899.973.88
2193427-193427102.193102.78
3188473-18847399.576100.11
4183531-18353196.96597.51
5175954-17595492.96293.44
6194072-194072102.534103.12
20min1196645-196645103.89499.384.25105.03100.484.25
2197384-197384104.284105.44
3185897-18589798.21599.30
4177519-17751993.78994.87
5181697-18169795.99696.99
6189473-189473100.104101.26
30min1188790-18879099.74396.153.65101.4697.813.67
2187074-18707498.837100.57
3176908-17690893.46695.09
4177607-17760793.83595.44
5173712-17371291.77793.31
6187885-18788599.265100.97
45min1195007-195007103.02898.204.95105.30100.394.92
2187884-18788499.265101.55
3191440-191440101.144103.29
4183413-18341396.90399.03
5168857-16885789.21291.25
6188605-18860599.646101.91
极限1185715-18571598.11999.792.19100.96102.522.14
2188625-18862599.656102.49
3187955-18795599.302102.01
4196285-196285103.703106.37
5184649-18464997.556100.09
6190051-190051100.410103.22
盐酸达伯西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.122028752026412026282024702025552026340.08
215.932030792032722031760.07
单位质量响应值RSD%判断
12570.3512754.301.03数据可信
供试品溶液-2024042421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%
5min116184-161848.5659.7331.748.569.7331.76
217503-175039.2639.26
39358-93584.9524.95
424505-2450512.96812.97
525102-2510213.28413.28
617656-176569.3439.34
10min170947-7094737.54538.379.1237.5938.429.14
278729-7872941.66341.71
360781-6078132.16532.19
477938-7793841.24441.32
571208-7120837.68337.76
675439-7543939.92239.97
15min1112343-11234359.45158.284.5859.7158.554.60
2109220-10922057.79958.08
3102669-10266954.33254.54
4117493-11749362.17762.48
5111817-11181759.17359.46
6107224-10722456.74357.02
20min1122348-12234864.74664.542.8165.3365.132.82
2124056-12405665.65066.25
3120372-12037263.70064.21
4127332-12733267.38468.03
5120076-12007663.54464.16
6117603-11760362.23562.82
30min1126225-12622566.79865.221.9067.7466.171.93
2121302-12130264.19365.16
3120300-12030063.66264.52
4125557-12555766.44467.47
5123557-12355765.38666.35
6122498-12249864.82565.76
45min1127868-12786867.66767.782.3468.9869.092.37
2130243-13024368.92470.25
3123013-12301365.09866.31
4131342-13134269.50670.90
5129319-12931968.43569.76
6126656-12665667.02668.32
极限1136656-13665672.31871.042.1474.0172.732.11
2132649-13264970.19771.91
3135747-13574771.83773.41
4137753-13775372.89874.67
5132126-13212669.92171.63
6130549-13054969.08670.75
盐酸达伯西汀片项目信息
介质体积(ml)900取样体积(ml)5补液体积(ml)5
对照品批号DSZJ-4057-240226对照品来源自制工作对照品对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数2000
标示量(mg)30供试品稀释倍数5系数0.8934
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.122023432023892021722021042022042022420.06
215.932048872049572049220.03
单位质量响应值RSD%判断
12546.0312863.901.77数据可信
供试品溶液-29003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%
5min131286-3128616.50312.6827.3116.5012.6827.31
215610-156108.2348.23
325848-2584813.63413.63
418312-183129.6599.66
521945-2194511.57511.58
631197-3119716.45616.46
10min179952-7995242.17339.877.6242.2639.947.65
272230-7223038.09938.15
375414-7541439.77939.85
467486-6748635.59735.65
574549-7454939.32339.39
683877-8387744.24344.33
15min1120811-12081163.72560.545.2364.0560.835.26
2111057-11105758.58058.84
3115150-11515060.73961.04
4106436-10643656.14256.39
5112932-11293259.56959.85
6122267-12226764.49364.83
20min1127378-12737867.18966.682.9167.8767.312.94
2124292-12429265.56166.14
3123373-12337365.07665.71
4122714-12271464.72965.29
5128427-12842767.74268.36
6132322-13232269.79770.49
30min1127106-12710667.04567.271.3768.1068.271.33
2128686-12868667.87968.83
3129012-12901268.05169.05
4125636-12563666.27067.19
5129370-12937068.23969.23
6125426-12542666.15967.24
45min1129004-12900468.04667.711.5369.4769.081.52
2126605-12660566.78168.11
3131839-13183969.54270.92
4127331-12733167.16468.45
5128630-12863067.84969.22
6126762-12676266.86468.31
极限1136614-13661472.06071.332.2073.8673.082.20
2136419-13641971.95873.65
3134681-13468171.04172.80
4132338-13233869.80571.47
5131681-13168169.45871.20
6139650-13965073.66275.48
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