厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.309057090554907039063290494905910.09
212.379044790242903440.17
单位质量响应值RSD%判断
7365.127303.480.60数据可信
供试品溶液-FA4444批-氢氯噻嗪-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min131181-3118133.91029.957.5233.9129.957.52
226780-2678029.12429.12
324787-2478726.95626.96
427583-2758329.99730.00
527475-2747529.87929.88
627441-2744129.84229.84
10min183448-8344890.75189.421.3290.9289.571.33
282045-8204589.22589.37
381203-8120388.30988.44
480884-8088487.96288.11
583425-8342590.72690.88
682322-8232289.52689.68
15min190595-9059598.52397.451.7499.1598.051.74
287635-8763595.30495.90
388540-8854096.28896.86
488717-8871796.48197.07
591758-9175899.788100.39
690423-9042398.33698.93
20min191384-9138499.38199.351.33100.50100.441.33
291731-9173199.759100.83
390148-9014898.03799.09
489870-8987097.73598.81
593181-93181101.335102.44
691828-9182899.864100.95
30min188772-8877296.54199.221.5898.15100.801.55
291570-9157099.584101.15
391558-9155899.570101.12
490567-9056798.493100.05
592979-92979101.116102.72
691969-91969100.017101.61
45min190931-9093198.889100.221.22100.98102.301.20
290790-9079098.735100.80
392430-92430100.519102.56
492307-92307100.385102.44
593710-93710101.911104.03
692754-92754100.871102.96
60min192018-92018100.07199.830.85102.66102.400.85
290687-9068798.623101.18
391285-9128599.274101.82
491569-9156999.582102.14
592835-92835100.959103.58
692375-92375100.459103.05
极限191800-9180099.834100.760.93102.92103.830.91
293902-93902102.120105.17
392033-92033100.087103.13
492060-92060100.116103.17
593439-93439101.616104.74
692663-92663100.772103.87
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804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1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.812569362573912578872577102570022573850.17
214.842569132573882571500.14
单位质量响应值RSD%判断
17379.1417328.170.21数据可信
供试品溶液-FA4444批-厄贝沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min176393-7639329.34825.987.1229.3525.987.12
266634-6663425.59925.60
361573-6157323.65423.65
466902-6690225.70125.70
567236-6723625.83025.83
666971-6697125.72825.73
10min1223598-22359885.89984.381.2086.0584.501.21
2220079-22007984.54784.67
3217909-21790983.71383.83
4215941-21594182.95783.09
5220985-22098584.89585.02
6219292-21929284.24584.37
15min1256187-25618798.41896.771.6098.9997.321.60
2246918-24691894.85795.41
3248142-24814295.32895.86
4250410-25041096.19996.74
5256075-25607598.37598.93
6253704-25370497.46498.01
20min1261062-261062100.29199.411.01101.36100.441.01
2259816-25981699.812100.84
3254771-25477197.87498.89
4256454-25645498.52199.55
5261172-261172100.333101.38
6259271-25927199.603100.64
30min1253814-25381497.50799.071.0599.08100.601.02
2259400-25940099.653101.18
3259352-25935299.634101.14
4255359-25535998.10099.62
5260728-260728100.163101.71
6258603-25860399.346100.88
45min1259347-25934799.63299.670.65101.69101.700.65
2256905-25690598.694100.72
3260575-260575100.104102.11
4258522-25852299.315101.32
5261807-261807100.577102.63
6259550-25955099.710101.74
60min1260504-260504100.07798.840.81102.63101.370.81
2255069-25506997.989100.50
3256894-25689498.690101.19
4255171-25517198.028100.53
5258476-25847699.298101.85
6257635-25763598.975101.51
极限1260134-26013499.93599.671.13102.99102.691.10
2263925-263925101.391104.40
3259585-25958599.724102.72
4255176-25517698.030101.02
5260209-26020999.963103.01
6257649-25764998.980102.01
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.309062190440905569060190564905560.08
212.379018990232902100.04
单位质量响应值RSD%判断
7362.287292.640.68数据可信
供试品溶液-FA4444批-氢氯噻嗪-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123043-2304325.08325.191.0425.0825.191.04
222939-2293924.97024.97
323523-2352325.60625.61
423363-2336325.43125.43
523001-2300125.03725.04
622996-2299625.03225.03
10min177713-7771384.59386.851.7384.7286.971.73
278554-7855485.50985.63
380408-8040887.52787.65
479926-7992687.00287.13
581159-8115988.34488.47
680952-8095288.11988.24
15min182364-8236489.65693.122.3690.2093.682.35
287050-8705094.75795.31
385425-8542592.98893.55
484460-8446091.93792.50
588125-8812595.92796.49
685835-8583593.43494.00
20min186689-8668994.36495.791.2995.3696.821.29
289205-8920597.10398.13
386719-8671994.39695.43
487680-8768095.44396.46
588848-8884896.71497.76
688878-8887896.74797.78
30min187609-8760995.36597.991.6496.8399.491.64
290259-9025998.25099.76
388918-8891896.79098.29
490887-9088798.933100.43
591480-9148099.579101.11
690974-9097499.028100.54
45min187911-8791195.69497.311.5697.6499.301.55
291221-9122199.297101.30
387591-8759195.34697.33
489521-8952197.44799.44
589898-8989897.85799.88
690205-9020598.191100.20
60min186984-8698494.68598.492.0397.11100.982.01
292213-92213100.377102.88
390299-9029998.293100.76
490683-9068398.711101.19
591304-9130499.387101.90
691416-9141699.509102.01
极限188675-8867596.52699.361.9199.42102.331.87
292373-92373100.551103.55
392221-92221100.386103.34
493118-93118101.362104.34
589640-8964097.576100.59
691644-9164499.757102.76
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804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1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.812571482572162569262573102567222570640.10
214.842566662564522565590.06
单位质量响应值RSD%判断
17357.4617288.340.29数据可信
供试品溶液-FA4444批-厄贝沙坦-pH1.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min155491-5549121.35621.461.6121.3621.461.61
254758-5475821.07421.07
357375-5737522.08122.08
456006-5600621.55421.55
555282-5528221.27521.28
655626-5562621.40821.41
10min1206532-20653279.48481.431.7079.5981.541.70
2208359-20835980.18780.29
3213155-21315582.03282.14
4211211-21121181.28481.39
5215737-21573783.02683.13
6214542-21454282.56682.67
15min1229867-22986788.46491.892.6888.9792.402.67
2243613-24361393.75494.26
3241299-24129992.86493.38
4232876-23287689.62290.14
5246539-24653994.88095.40
6238391-23839191.74492.26
20min1242086-24208693.16694.761.4494.1195.731.44
2250870-25087096.54797.52
3244430-24443094.06995.05
4243385-24338593.66694.63
5249663-24966396.08297.08
6246900-24690095.01996.00
30min1244763-24476394.19796.671.4795.6198.121.47
2253791-25379197.67199.13
3250484-25048496.39897.85
4250202-25020296.29097.72
5255143-25514398.19199.67
6252755-25275597.27298.73
45min1244538-24453894.11095.891.8595.9997.821.84
2256576-25657698.743100.69
3246335-24633594.80296.74
4245429-24542994.45396.37
5251557-25155796.81198.78
6250471-25047196.39398.33
60min1242584-24258493.35896.872.1595.7199.272.13
2258711-25871199.565102.00
3252338-25233897.11299.52
4249339-24933995.95898.34
5254208-25420897.832100.28
6253016-25301697.37399.79
极限1247650-24765095.30897.651.8198.13100.541.77
2258920-25892099.645102.58
3258157-25815799.351102.25
4255355-25535598.273101.14
5249588-24958896.05498.99
6252686-25268697.246100.15
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.309031190329903299048990312903540.09
212.379020490244902240.04
单位质量响应值RSD%判断
7345.857293.780.51数据可信
供试品溶液-FA4444批-氢氯噻嗪-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123540-2354025.65127.189.1225.6527.189.13
223817-2381725.95225.95
324911-2491127.14427.14
428933-2893331.52731.53
522541-2254124.56224.56
625914-2591428.23728.24
10min170437-7043776.75282.714.3676.8882.844.35
280275-8027587.47287.60
374217-7421780.87181.01
476439-7643983.29283.45
577061-7706183.97084.09
676998-7699883.90284.04
15min185722-8572293.40894.731.4193.9295.281.41
287519-8751995.36695.93
389119-8911997.10997.65
486199-8619993.92894.50
586471-8647194.22494.77
686556-8655694.31794.88
20min190610-9061098.73498.291.3399.7199.321.31
290620-9062098.74599.79
392227-92227100.496101.52
489280-8928097.28598.33
589215-8921597.21498.23
689271-8927197.27598.31
30min190880-9088099.02898.381.19100.5099.901.18
291470-9147099.671101.21
391375-9137599.568101.10
489403-8940397.41998.95
589167-8916797.16298.66
689421-8942197.43898.96
45min191967-91967100.21398.721.44102.18100.731.41
291900-91900100.140102.18
391371-9137199.563101.59
489800-8980097.85199.87
589040-8904097.02399.01
689497-8949797.52199.53
60min190534-9053498.65198.351.64101.12100.851.62
291334-9133499.523102.06
392444-92444100.732103.26
489620-8962097.655100.16
588426-8842696.35498.82
689200-8920097.19899.69
极限193097-93097101.44498.842.13104.41101.832.09
292480-92480100.772103.81
391645-9164599.862102.89
489243-8924397.244100.24
589088-8908897.076100.03
688674-8867496.62499.60
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804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1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.812568792569002570452571722567822569560.06
214.842569862568082568970.05
单位质量响应值RSD%判断
17350.1717311.120.16数据可信
供试品溶液-FA4444批-厄贝沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120224-202247.7808.478.657.788.478.66
222027-220278.4738.47
322484-224848.6498.65
425002-250029.6189.62
519707-197077.5817.58
622674-226748.7228.72
10min171945-7194527.67529.925.3727.7129.965.38
283613-8361332.16432.21
374011-7401128.47028.51
478990-7899030.38630.43
579053-7905330.41030.45
679126-7912630.43830.48
15min1104930-10493040.36441.411.9640.5441.601.96
2111291-11129142.81143.01
3106670-10667041.03341.22
4107129-10712941.21041.41
5108061-10806141.56841.76
6107742-10774241.44641.64
20min1127770-12777049.15049.221.1749.5349.621.17
2130661-13066150.26250.68
3127375-12737548.99849.39
4126125-12612548.51748.92
5127928-12792849.21149.61
6127931-12793149.21249.61
30min1154399-15439959.39458.771.4160.0259.421.40
2156359-15635960.14760.82
3151353-15135358.22258.86
4150785-15078558.00358.65
5152000-15200058.47159.11
6151817-15181758.40059.05
45min1181025-18102569.63668.161.6270.5669.101.60
2180697-18069769.51070.48
3175529-17552967.52268.45
4175121-17512167.36568.30
5175317-17531767.44068.38
6175387-17538767.46768.41
60min1194620-19462074.86673.671.3076.1474.951.28
2193640-19364074.48975.81
3192842-19284274.18275.45
4189021-18902172.71273.99
5189323-18932372.82874.10
6189600-18960072.93474.21
极限1213989-21398982.31679.282.3083.9680.932.26
2209565-20956580.61582.30
3205028-20502878.86980.50
4201896-20189677.66479.30
5203348-20334878.22379.86
6202779-20277978.00479.65
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100309-201404对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.7对照品水分(%)0对照品稀释倍数10000
标示量(mg)12.5供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
112.309018290339901279003890275901920.14
212.379044890437904420.01
单位质量响应值RSD%判断
7332.687311.400.21数据可信
供试品溶液-FA4444批-氢氯噻嗪-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min123909-2390926.04427.2712.7726.0427.2712.77
222356-2235624.35324.35
330551-3055133.28033.28
426735-2673529.12329.12
522012-2201223.97823.98
624628-2462826.82826.83
10min177468-7746884.38784.262.7184.5284.402.72
276875-7687583.74183.86
380643-8064387.84688.01
478163-7816385.14485.29
574217-7421780.84680.97
676743-7674383.59783.73
15min184060-8406091.56893.321.8492.1293.881.85
285294-8529492.91293.45
387519-8751995.33695.94
487303-8730395.10195.67
583820-8382091.30691.83
686011-8601193.69394.25
20min186867-8686794.62695.821.2995.6496.851.31
287734-8773495.57096.58
390143-9014398.19499.28
487353-8735395.15596.20
587733-8773395.56996.55
687961-8796195.81796.84
30min187571-8757195.39397.601.3596.8899.101.34
288865-8886596.80298.28
390629-9062998.724100.30
489565-8956597.56599.09
590529-9052998.615100.07
690413-9041398.48899.99
45min190197-9019798.25398.290.56100.21100.280.56
290450-9045098.529100.50
390772-9077298.879100.95
489388-8938897.37299.38
590610-9061098.703100.65
689980-8998098.017100.01
60min188666-8866696.58596.931.0199.0499.421.02
289154-8915497.11799.58
390707-9070798.809101.37
488685-8868596.60699.10
588249-8824996.13198.58
688445-8844596.34598.83
极限187530-8753095.34897.080.9498.28100.050.92
289099-8909997.057100.00
389098-8909897.056100.11
489516-8951697.511100.49
589799-8979997.819100.75
689674-8967497.683100.65
厄贝沙坦氢氯噻嗪片项目信息
介质体积(ml)1000取样体积(ml)5补液体积(ml)5
对照品批号100607-201804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1000
标示量(mg)150供试品稀释倍数10系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
114.812568892565452565212565642569232566880.08
214.842561252563242562240.06
单位质量响应值RSD%判断
17332.0717265.770.28数据可信
供试品溶液-FA4444批-厄贝沙坦-pH2.0
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120400-204007.8628.5212.337.868.5212.33
220631-206317.9517.95
327097-2709710.44310.44
423159-231598.9258.93
519722-197227.6017.60
621568-215688.3128.31
10min178596-7859630.28929.924.0030.3329.964.01
277248-7724829.77029.81
382862-8286231.93431.99
477736-7773629.95830.00
573596-7359628.36328.40
675823-7582329.22129.26
15min1103237-10323739.78639.842.3939.9840.032.41
2102264-10226439.41139.60
3107538-10753841.44341.66
4104375-10437540.22440.42
5100159-10015938.59938.78
6102654-10265439.56139.75
20min1120500-12050046.43946.562.1946.8346.962.20
2120270-12027046.35046.74
3126047-12604748.57649.00
4119392-11939246.01246.41
5118721-11872145.75346.13
6119993-11999346.24346.63
30min1140989-14098954.33555.851.7754.9656.481.77
2143522-14352255.31155.93
3148603-14860357.26957.93
4144695-14469555.76356.39
5146051-14605156.28556.89
6145679-14567956.14256.76
45min1167326-16732664.48464.841.1365.3865.751.14
2168233-16823364.83465.73
3171406-17140666.05767.01
4165861-16586163.92064.82
5169166-16916665.19466.08
6167569-16756964.57865.48
60min1178869-17886968.93369.521.4970.1570.751.49
2180769-18076969.66570.88
3185639-18563971.54272.82
4178928-17892868.95670.18
5179015-17901568.98970.20
6179111-17911169.02670.25
极限1188901-18890172.79974.501.3474.3676.081.33
2192363-19236374.13375.70
3196392-19639275.68677.32
4193180-19318074.44876.02
5194852-19485275.09276.65
6194279-19427974.87276.44
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