洛索洛芬钠细粒剂项目信息
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100638-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.761160911116179611582071160972116178111607330.13
213.741160474116274611616100.14
单位质量响应值RSD%判断
84355.6084542.210.16数据可信
供试品溶液-NPA3080批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11230312-123031295.60799.302.1795.6199.302.17
21278858-127885899.38099.38
31290410-1290410100.278100.28
41270056-127005698.69698.70
51314186-1314186102.125102.13
61283271-128327199.72399.72
10min11243905-124390596.66499.101.5996.8299.261.59
21274768-127476899.06299.23
31286018-128601899.936100.10
41269394-126939498.64498.81
51305352-1305352101.439101.61
61271874-127187498.83799.00
15min11264949-126494998.29999.931.3998.62100.261.40
21283256-128325699.722100.05
31293761-1293761100.538100.87
41275997-127599799.15799.49
51316926-1316926102.338102.68
61280541-128054199.51199.84
30min11268549-126854998.579100.091.3799.06100.591.37
21288791-1288791100.152100.65
31297044-1297044100.793101.29
41275793-127579399.14299.64
51317448-1317448102.379102.89
61280349-128034999.49699.99
极限11273544-127354498.96799.981.1899.62100.641.18
21284281-128428199.801100.47
31294993-1294993100.634101.30
41276105-127610599.16699.83
51313067-1313067102.038102.72
61277225-127722599.25399.92
洛索洛芬钠细粒剂项目信息
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100638-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.761160361116085911565671164411116287111610140.26
213.741159493115852911590110.06
单位质量响应值RSD%判断
84376.0284353.060.02数据可信
供试品溶液-NPA3080批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11279059-127905999.49598.381.0799.4998.381.07
21254223-125422397.56397.56
31282942-128294299.79799.80
41256268-125626897.72297.72
51251286-125128697.33497.33
61264365-126436598.35298.35
10min11277288-127728899.35799.361.2899.5299.521.28
21268800-126880098.69798.86
31297633-1297633100.940101.11
41288540-1288540100.232100.40
51250919-125091997.30697.47
61280695-128069599.62299.79
15min11281872-128187299.71499.960.84100.04100.280.84
21283937-128393799.874100.20
31287565-1287565100.156100.49
41295430-1295430100.768101.10
51266171-126617198.49298.82
61294903-1294903100.727101.06
30min11286866-1286866100.102100.130.77100.60100.620.77
21283967-128396799.876100.37
31298800-1298800101.030101.53
41296517-1296517100.853101.35
51271537-127153798.91099.40
61285595-1285595100.003100.50
极限11277617-127761799.38399.650.96100.05100.310.96
21274916-127491699.17299.83
31295464-1295464100.771101.44
41293737-1293737100.636101.30
51262855-126285598.23498.89
61281786-128178699.707100.37
洛索洛芬钠细粒剂项目信息
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100638-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.761157429116266611568941158244115722611584920.21
213.741160227115943511598310.05
单位质量响应值RSD%判断
84192.7384412.740.19数据可信
供试品溶液-2025020821批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11148175-114817589.37986.572.9289.3886.562.92
21059455-105945582.47382.47
31104261-110426185.96185.96
41126404-112640487.68487.68
51137818-113781888.57388.57
61096150-109615085.32985.33
10min11225789-122578995.42192.742.3895.5792.892.38
21158311-115831190.16890.31
31178300-117830091.72491.87
41208293-120829394.05994.21
51213738-121373894.48394.63
61163686-116368690.58790.73
15min11263127-126312798.32895.612.1898.6495.912.18
21202042-120204293.57293.86
31212701-121270194.40294.70
41245322-124532296.94297.24
51246183-124618397.00997.31
61199773-119977393.39693.69
30min11300051-1300051101.20298.012.27101.6798.462.27
21243350-124335096.78897.23
31236193-123619396.23196.68
41274912-127491299.24599.71
51274150-127415099.18699.65
61225266-122526695.38095.83
极限11314141-1314141102.29998.862.37102.9499.482.37
21252325-125232597.48798.09
31247088-124708897.07997.69
41284057-128405799.957100.59
51287422-1287422100.219100.85
61234831-123483196.12596.73
洛索洛芬钠细粒剂项目信息
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100638-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.761156186115933411613951157280116106711590520.20
213.741158415115578211570980.17
单位质量响应值RSD%判断
84233.4384213.830.02数据可信
供试品溶液-2025020821批-pH1.2
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min11149294-114929489.55086.7610.1189.5586.7610.11
21139305-113930588.77288.77
31185818-118581892.39692.40
41149284-114928489.54989.55
51170788-117078891.22591.22
6886431-88643169.06969.07
10min11221784-122178495.19893.236.5395.3593.386.54
21204050-120405093.81793.96
31251855-125185597.54197.70
41219189-121918994.99695.15
51241256-124125696.71696.87
61040850-104085081.10081.22
15min11252381-125238197.58296.244.7997.8996.544.80
21237149-123714996.39696.70
31280377-128037799.764100.08
41250215-125021597.41497.72
51271736-127173699.09199.40
61118771-111877187.17287.42
30min11265458-126545898.60199.011.9899.0799.472.00
21257466-125746697.97998.44
31306296-1306296101.783102.27
41271432-127143299.06799.54
51289630-1289630100.485100.96
61234157-123415796.16396.56
极限11278242-127824299.598100.461.37100.23101.081.37
21266105-126610598.65299.28
31311863-1311863102.217102.87
41278550-127855099.622100.26
51303929-1303929101.599102.24
61296846-1296846101.047101.60
洛索洛芬钠细粒剂项目信息
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100638-202405对照品来源中检所对照品使用方法直接使用
对照品含量(%)87.5对照品水分(%)0对照品稀释倍数200
标示量(mg)60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%
113.761161700116191811616661162450116185711619180.03
213.741160814116044311606280.03
单位质量响应值RSD%判断
84441.7284470.740.03数据可信
供试品溶液-NPA3080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%
5min11306277-1306277101.502100.361.35101.50100.361.34
21303976-1303976101.323101.32
31308419-1308419101.668101.67
41287457-1287457100.039100.04
51267350-126735098.47798.48
61276001-127600199.14999.15
10min11308768-1308768101.695100.761.27101.86100.931.27
21311537-1311537101.910102.08
31311575-1311575101.913102.08
41292660-1292660100.444100.61
51273467-127346798.95299.12
61282488-128248899.65399.82
15min11308931-1308931101.708100.661.40102.05101.001.40
21312468-1312468101.983102.32
31310362-1310362101.819102.16
41292669-1292669100.444100.78
51269927-126992798.67799.01
61278705-127870599.35999.69
30min11305420-1305420101.435100.341.46101.94100.851.46
21308677-1308677101.688102.20
31306458-1306458101.516102.02
41289326-1289326100.184100.69
51264281-126428198.23898.73
61274080-127408099.00099.50
极限11304472-1304472101.361100.171.34102.04100.841.34
21305808-1305808101.465102.14
31299933-1299933101.009101.69
41285929-128592999.921100.59
51263341-126334198.16598.82
61275656-127565699.12299.78
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