替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.95456065446035451925462185463115455860.14
2112.95456215462815459510.09
单位质量响应值RSD%判断
4875.664835.700.59数据可信
供试品溶液-49G03N批-pH1.2(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1364775-36477566.53069.352.0766.5369.352.07
2383455-38345569.93769.94
3382123-38212369.69469.69
4383135-38313569.87969.88
5380752-38075269.44469.44
6387072-38707270.59770.60
10min1423886-42388677.31178.650.9977.4278.761.00
2433401-43340179.04779.16
3429527-42952778.34078.46
4433161-43316179.00379.12
5431032-43103278.61578.73
6436270-43627079.57079.69
15min1447620-44762081.64082.940.9881.8883.180.99
2455430-45543083.06583.31
3452998-45299882.62182.87
4456681-45668183.29383.54
5454561-45456182.90683.15
6461138-46113884.10684.36
20min1460208-46020883.93684.960.8484.3185.350.84
2467182-46718285.20885.59
3464567-46456784.73185.12
4465988-46598884.99085.38
5464973-46497384.80585.19
6472127-47212786.11086.50
30min1467852-46785285.33086.750.9285.8587.280.92
2477409-47740987.07387.60
3476465-47646586.90187.43
4476338-47633886.87887.41
5474818-47481886.60187.13
6481051-48105187.73888.27
45min1472990-47299086.26787.380.7686.9388.050.76
2481886-48188687.89088.56
3479461-47946187.44888.12
4477629-47762987.11487.79
5479039-47903987.37188.04
6483384-48338488.16388.84
60min1468217-46821785.39786.841.1886.2087.651.18
2478278-47827887.23288.05
3475273-47527386.68487.50
4475356-47535686.69987.52
5474161-47416186.48187.30
6485361-48536188.52489.35
极限1471162-47116285.93486.710.8186.8887.670.81
2478902-47890287.34688.31
3474081-47408186.46687.43
4473961-47396186.44587.41
5473106-47310686.28987.25
6481246-48124687.77388.75
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.95468365469545474105471585464885469690.07
2112.95483565481025482290.04
单位质量响应值RSD%判断
4888.024855.880.47数据可信
供试品溶液-49G03N批-pH1.2(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1378806-37880668.85867.582.2968.8667.582.29
2380007-38000769.07769.08
3372666-37266667.74267.74
4375567-37556768.27068.27
5358035-35803565.08365.08
6365538-36553866.44766.45
10min1427215-42721577.65876.541.5977.7776.651.60
2427796-42779677.76477.88
3420855-42085576.50276.61
4424296-42429677.12777.24
5414829-41482975.40675.51
6411508-41150874.80374.91
15min1447442-44744281.33580.511.2581.5880.761.26
2450126-45012681.82382.07
3442287-44228780.39880.64
4444216-44421680.74880.99
5437749-43774979.57379.81
6435713-43571379.20379.44
20min1456809-45680983.03882.571.1783.4282.941.17
2461149-46114983.82684.21
3454393-45439382.59882.97
4456480-45648082.97883.35
5450533-45053381.89782.26
6446117-44611781.09481.46
30min1464478-46447884.43284.311.1984.9584.821.19
2471827-47182785.76786.29
3464876-46487684.50485.02
4465114-46511484.54785.06
5461507-46150783.89184.39
6455031-45503182.71483.22
45min1468794-46879485.21684.841.0785.8785.491.07
2473808-47380886.12886.79
3467919-46791985.05785.71
4467635-46763585.00585.66
5462658-46265884.10184.74
6459631-45963183.55084.19
60min1466733-46673384.84184.361.1185.6485.151.10
2471208-47120885.65586.46
3465223-46522384.56785.36
4464876-46487684.50485.30
5459036-45903683.44284.23
6457353-45735383.13683.92
极限1460664-46066483.73883.820.8684.6884.750.87
2467970-46797085.06686.02
3462547-46254784.08185.02
4460784-46078483.76084.70
5457079-45707983.08784.01
6457518-45751883.16684.08
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.95581635562385558505547165534925556920.32
2112.95523295498895511090.32
单位质量响应值RSD%判断
4965.974881.391.22数据可信
供试品溶液-49G03N批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1376260-37626067.68167.190.8967.6867.190.89
2374981-37498167.45167.45
3372548-37254867.01367.01
4369550-36955066.47466.47
5370281-37028166.60666.61
6377686-37768667.93867.94
10min1429088-42908877.18476.650.7877.3076.760.78
2425982-42598276.62576.74
3427470-42747076.89377.00
4419773-41977375.50875.62
5426455-42645576.71076.82
6427925-42792576.97577.09
15min1457586-45758682.31081.720.5482.5581.950.54
2453954-45395481.65781.90
3455278-45527881.89582.13
4450122-45012280.96781.20
5454080-45408081.67981.92
6454657-45465781.78382.02
20min1479496-47949686.25185.050.7886.6385.430.77
2472016-47201684.90685.28
3472141-47214184.92885.30
4468398-46839884.25584.63
5473187-47318785.11685.49
6471764-47176484.86085.24
30min1498848-49884889.73288.750.7790.2589.260.77
2491803-49180388.46588.98
3494001-49400188.86089.38
4487732-48773287.73388.24
5492240-49224088.54489.06
6495633-49563389.15489.67
45min1513158-51315892.30691.180.7692.9891.850.76
2505572-50557290.94291.61
3506594-50659491.12591.79
4501251-50125190.16490.82
5507406-50740691.27291.94
6507440-50744091.27891.95
60min1519911-51991193.52192.320.7394.3593.140.73
2511138-51113891.94392.76
3513765-51376592.41593.23
4508886-50888691.53892.35
5513473-51347392.36393.18
6512115-51211592.11992.94
极限1525807-52580794.58192.911.0095.5693.881.00
2514957-51495792.63093.60
3515766-51576692.77593.75
4510742-51074291.87292.83
5517898-51789893.15994.13
6513758-51375892.41493.39
替普瑞酮颗粒项目信息
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3A5724009091对照品来源原料药对照品使用方法直接使用
对照品含量(%)98.4对照品水分(%)0对照品稀释倍数2000
标示量(mg)50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%
1111.95551455555235556545546215539905549870.13
2112.95534965543265539110.11
单位质量响应值RSD%判断
4959.674906.210.77数据可信
供试品溶液-49G03N批-pH6.8(内含2%SDS)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1380075-38007568.23667.433.2668.2467.433.26
2381650-38165068.51968.52
3379274-37927468.09268.09
4350708-35070862.96462.96
5380948-38094868.39368.39
6380910-38091068.38668.39
10min1432354-43235477.62276.612.8077.7476.722.80
2428458-42845876.92277.04
3432162-43216277.58777.70
4402656-40265672.29072.40
5430810-43081077.34577.46
6433787-43378777.87977.99
15min1461249-46124982.80981.662.8683.0581.902.86
2459164-45916482.43582.68
3461018-46101882.76883.01
4428483-42848376.92777.15
5457537-45753782.14382.39
6461508-46150882.85683.10
20min1479316-47931686.05385.172.0586.4385.552.05
2477267-47726785.68586.07
3478741-47874185.95086.33
4454765-45476581.64582.00
5476450-47645085.53985.92
6479832-47983286.14686.53
30min1498744-49874489.54188.931.6390.0789.451.64
2497980-49798089.40489.93
3499496-49949689.67690.20
4479348-47934886.05986.55
5495204-49520488.90689.43
6501138-50113889.97190.50
45min1514426-51442692.35791.661.2893.0392.321.29
2511376-51137691.80992.48
3515901-51590192.62193.29
4497764-49776489.36590.00
5511163-51116391.77192.44
6512487-51248792.00892.68
60min1517773-51777392.95792.731.0993.7993.541.10
2517781-51778192.95993.78
3520994-52099493.53694.36
4505320-50532090.72291.50
5519326-51932693.23694.06
6517680-51768092.94193.77
极限1523424-52342493.97293.470.9994.9594.441.00
2520380-52038093.42594.41
3524373-52437394.14295.13
4510615-51061591.67292.61
5521213-52121393.57594.55
6523717-52371794.02595.01
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