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  • Ba - Cervugid X 12ovule

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    BA_CERVUGID X 12OVULE

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    40 views2 pages

    Ba - Cervugid X 12ovule

    Uploaded by

    Georgiana Ivan

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    ircon” DEPARTAMENT CONTROLUL CALITATIL BULETIN DE ANALIZA Nr. 24 OVL/ 03.03.2020 Denumirea produsul: CERVUGID ovule Productor: IRCON SRL, Iasi, Romania Detindtor APP: IRCON SRL, Iasi, Romi Data prelevarii: 21.02.2020 Compozitie: 500 mg Metronidazol, 200 mg Cloramfenicol, 660000 UL Seria : 090 Cantitate/serie: 3956 U.C. 7 Data fabricajei: 02.2020 Data expirarii: 01.2022 Nistatin, 15 mg Acetat de Hidrocortizon si excipient pint la 3000 mg Analiza este efectuata conform specificatiei tehnice ST-PF-001. ‘CARACTERISTICI LIMITE DE ADMISIBILITATE REZULTATE | Deseriere: ~ aspect Ovule de forma torpila, cu suprafays neteda, Conform rezentind in sectiune un aspect omogen - exloare Galbeni Galbent + miros Fara miros Fart miros Uniformitatea masei preparatelor unidoza = masa medie, mg/ovul 3000 + 5 % (2850 ~ 3150) 2930 ~ uniformitatea masei Conf. prev. Conform Dezagregare, min Max. 60 40 ; Spoturile obtinute trebuie si fie de aceeasi Kentineare metroid orate yi Pauling nies fe denecai | ¢u spoturile din solutia etalon corespunzitoare Identificare acetat de hidrocortizon Coloratie albastru-violet Conform PPicurile principale de pe cromatograma solutiei Tdentificare metronidazol, cloramfenicol $i de analizatcorespund ca timpi de retentie ca oe acetat de hidrocortizon picurile principale de pe cromatograma solutiei ‘on de referinga Substange tnrudite chimic, % Cu cloramfenicol: Impuritatea A Max. 0,2 ND Impuritati nespecifice Max. 0,10 0,053/0,094 Impuritii totale Max. 0,5 0,147 ‘Cu metronidazo!: orice impuritate Max. 0,08 0013, total impuritgi Max. 0,2 0,013 (Cu acetat de hidrocortizon Impuritatea C Max. 0,6 ND Impuritatea A Max. 0,4 ND Impuritatea B, D, E Max. 0.3 ‘NDINDIO,078 Impuritatea G Max. 0, 15, 0,140 Impuritati nespecifice Max. 0,10 0,081 Impurity totale Max. 1,0 0,299 Dozare: = metronidazol, mg/ovul 500 + 5 % (475,0-$25,0) 503,31 + cloramfenicol, ma/ovul 200 5 % (190,0 ~210,0) 198,87 = _acetat de hidrocontizon, mg/ovul 15 45% (14,25 ~ 15,75) 14,72 Uniformitatea confinutului in acetat de fe hidrocortizon ed co Determinarea activitifii microbiologice a 7 ie Ragan cused 1627000 ~ 693000 673.650 Calitate mierobiologica: ~ Nr total bacteri aerobe, ufe/g Max. 10? <1 ~ Nr. total levuri gi fungi, ufe/g Max. 10!

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