贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
19.863004953003223007382997522999813002580.14
29.932988032979412983720.21
单位质量响应值RSD%判断
30452.1330047.530.95数据可信
供试品溶液-2024090421批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1147154-14715448.51248.253.0848.5148.253.08
2150764-15076449.70249.70
3147270-14727048.55048.55
4151027-15102749.78949.79
5140568-14056846.34146.34
6141345-14134546.59746.60
10min1233146-23314676.86178.081.5376.9478.161.53
2234765-23476577.39577.48
3243671-24367180.33180.41
4236981-23698178.12578.21
5236085-23608577.83077.91
6236501-23650177.96778.04
15min1262310-26231086.47687.271.1186.6887.471.11
2263082-26308286.73086.94
3269632-26963288.88989.10
4265329-26532987.47187.68
5265993-26599387.69087.90
6261887-26188786.33686.54
20min1274575-27457590.51991.041.1490.8791.401.14
2274439-27443990.47490.83
3279789-27978992.23892.60
4277386-27738691.44691.80
5279079-27907992.00492.36
6271664-27166489.55989.91
30min1282581-28258193.15893.861.1293.6694.361.12
2282409-28240993.10293.61
3288119-28811994.98495.50
4285639-28563994.16694.68
5288484-28848495.10495.61
6280966-28096692.62693.13
45min1285464-28546494.10995.221.1894.7795.881.17
2288689-28868995.17295.83
3292859-29285996.54797.22
4289153-28915395.32595.99
5292229-29222996.33997.00
6284588-28458893.82094.48
60min1286982-28698294.60995.561.2395.4396.381.22
2288704-28870495.17796.00
3293265-29326596.68197.52
4290169-29016995.66096.49
5294552-29455297.10597.93
6285470-28547094.11194.92
极限1295968-29596897.57297.680.7998.5598.660.79
2296499-29649997.74798.73
3297664-29766498.13199.13
4297738-29773898.15599.14
5298026-29802698.25099.24
6291861-29186196.21897.19
贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
19.862983672982062986002984362986692984560.07
29.932977772984522981140.17
单位质量响应值RSD%判断
30269.3730021.550.59数据可信
供试品溶液-2024090421批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1126312-12631241.78443.485.4141.7843.485.41
2135467-13546744.81344.81
3129464-12946442.82742.83
4121997-12199740.35740.36
5142071-14207146.99747.00
6133379-13337944.12244.12
10min1240594-24059479.58979.210.9579.6679.280.95
2240997-24099779.72279.80
3242046-24204680.06980.14
4237079-23707978.42678.49
5239677-23967779.28679.36
6236358-23635878.18878.26
15min1271885-27188589.94089.300.6890.1489.500.68
2269588-26958889.18089.39
3271614-27161489.85090.06
4268170-26817088.71188.91
5270903-27090389.61589.83
6267495-26749588.48888.69
20min1283378-28337893.74293.270.6094.0993.620.60
2279794-27979492.55692.91
3283945-28394593.92994.28
4280777-28077792.88193.23
5282910-28291093.58793.95
6280855-28085592.90793.26
30min1292398-29239896.72696.160.7197.2396.670.71
2289132-28913295.64596.16
3293184-29318496.98697.50
4288776-28877695.52896.03
5291961-29196196.58197.10
6288702-28870295.50396.01
45min1295322-29532297.69397.330.6598.3698.000.64
2293082-29308296.95297.62
3297253-29725398.33299.00
4293329-29332997.03497.69
5294372-29437297.37998.06
6291936-29193696.57397.24
60min1297948-29794898.56297.860.6999.3998.690.69
2296112-29611297.95498.79
3298283-29828398.67399.51
4294266-29426697.34498.17
5295116-29511697.62598.46
6293182-29318296.98597.81
极限1299694-29969499.13998.620.71100.1499.620.71
2297237-29723798.32699.32
3301408-30140899.706100.71
4296138-29613897.96398.95
5298082-29808298.60699.61
6296154-29615497.96898.96
贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
19.862981302994052988762989862986642988120.16
29.932978082987372982720.23
单位质量响应值RSD%判断
30305.4830037.460.63数据可信
供试品溶液-2024090421批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1127963-12796342.29443.456.7642.2943.446.76
2130500-13050043.13343.13
3132531-13253143.80443.80
4125124-12512441.35641.36
5148395-14839549.04749.05
6124177-12417741.04341.04
10min1240677-24067779.54878.490.8479.6278.560.84
2236082-23608278.02978.10
3237602-23760278.53278.60
4237924-23792478.63878.71
5237793-23779378.59578.68
6234781-23478177.59977.67
15min1271214-27121489.64188.380.7689.8488.580.76
2265700-26570087.81888.02
3267276-26727688.33988.54
4267541-26754188.42788.63
5266966-26696688.23788.45
6265707-26570787.82188.02
20min1284731-28473194.10992.790.8094.4693.140.79
2278645-27864592.09792.45
3279029-27902992.22492.58
4280231-28023192.62192.97
5281682-28168293.10193.46
6280166-28016692.60092.94
30min1293804-29380497.10796.160.6197.6296.660.61
2290121-29012195.89096.39
3289506-28950695.68796.19
4290520-29052096.02296.52
5292256-29225696.59697.11
6289348-28934895.63596.13
45min1298631-29863198.70397.790.5599.3798.450.55
2295775-29577597.75998.42
3293793-29379397.10497.77
4295347-29534797.61798.28
5296480-29648097.99298.67
6295140-29514097.54998.21
60min1299877-29987799.11598.280.5299.9599.110.52
2297417-29741798.30299.13
3295368-29536897.62498.45
4297510-29751098.33299.16
5297750-29775098.41299.25
6296208-29620897.90298.72
极限1305562-305562100.99498.931.09101.9999.921.08
2299932-29993299.133100.12
3297018-29701898.17099.16
4297587-29758798.35899.35
5298637-29863798.70599.71
6297148-29714898.21399.20
贝派度酸片项目信息
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BEMA-231010D对照品来源自制对照品使用方法直接使用
对照品含量(%)99.72对照品水分(%)0对照品稀释倍数50
标示量(mg)180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%
19.863016703018263010653022063017623017060.14
29.932992192996872994530.12
单位质量响应值RSD%判断
30598.9930156.391.04数据可信
供试品溶液-2024090421批-pH6.6
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min1143541-14354147.12247.729.5547.1247.729.55
2134822-13482244.26044.26
3161619-16161953.05753.06
4125687-12568741.26141.26
5147185-14718548.31948.32
6159270-15927052.28652.29
10min1242805-24280579.70980.270.5479.7980.350.54
2243799-24379980.03580.11
3246532-24653280.93381.02
4244248-24424880.18380.25
5245433-24543380.57280.65
6244352-24435280.21780.30
15min1273775-27377589.87689.760.5290.0989.980.52
2273275-27327589.71289.92
3274421-27442190.08890.31
4275034-27503490.28990.49
5270931-27093188.94289.16
6273182-27318289.68189.90
20min1284986-28498693.55793.390.6793.9293.750.67
2284578-28457893.42393.78
3285649-28564993.77494.15
4286348-28634894.00494.36
5280881-28088192.20992.57
6284381-28438193.35893.73
30min1293084-29308496.21596.090.7096.7396.610.69
2293949-29394996.49997.01
3292934-29293496.16696.70
4294906-29490696.81397.32
5288977-28897794.86795.38
6292415-29241595.99596.52
45min1296836-29683697.44797.230.6798.1297.910.66
2298290-29829097.92498.60
3295608-29560897.04497.73
4298101-29810197.86298.53
5293176-29317696.24596.92
6295059-29505996.86397.55
60min1298859-29885998.11197.700.9398.9598.540.92
2299496-29949698.32099.16
3297505-29750597.66698.52
4300907-30090798.78399.62
5293499-29349996.35197.19
6295305-29530596.94497.79
极限1302114-30211499.17998.970.84100.1899.970.83
2303999-30399999.798100.80
3301651-30165199.027100.04
4304064-30406499.820100.82
5297979-29797997.82298.82
6298982-29898298.15199.16
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