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MINIMUM FILL
Remove the contents from each container by employing any safe technique (e.g., chill to reduce the internal pressure, remove the valve, and pour). Remove any residual contents with suitable solvents, then rinse with a few portions of methanol. Retain as a unit the container, the valve, and all associated parts, and heat them at 100for 5 minutes.
DETERMINATION OF VOLUME OF INJECTION IN Injections in Cartridges or Prefilled Syringes— Select 1 container if the volume is 10 mL or more, 3 containers if the nominal volume is more than 3 mL and less than 10 mL, or 5 containers if the nominal volume is 3 mL or less. If necessary, fit the containers with the accessories required for their use (needle, piston, syringe) and transfer the entire contents of each container without QUALITY ASSURANCE IN PHARMACEUTICAL … A quality assurance program is a system of steps and actions taken to ensure the maintenance of proper standards in compounded preparations. The need for a quality assurance system is well documented in USP chapters (see Compounding Controls under Good Compounding Practices 1075; Quality Control and Verification under Pharmaceutical Compounding—Nonsterile Preparations 795; and The QualityCASTOR OIL EMULSION
Castor Oil Emulsion. Packaging and storage— Preserve in tight containers. Identification— Shake well, and place about 10 mL in a 125-mL separator. Add 10 mL of 1 N hydrochloric acid and about 20 mL of solvent hexane. Shake vigorously for 2 to 3 minutes, allow the layers to separate, discard the aqueous phase, and filter the upperlayer
TRANSFUSION AND INFUSION ASSEMBLIES AND SIMILAR 128 〈151〉 Pyrogen Test / Biological Tests USP 35 For the rabbit pyrogen test, inject (1/7) of the vial contents for Bacterial Endotoxins, but with volumes of rinse or extrac- per kg of body weight into each rabbit. The maximum dosetion fluid not to exceed 40 mL of sterile saline TS per de- BIOLOGICAL REACTIVITY TESTS, IN VIVO 94 〈87〉 Biological Reactivity Tests, In Vitro / Biological Tests USP 35 (mildly reactive). Repeat the procedure if the suitability oflogical Reactivity Tests, In Vitro 〈87〉 have indicated significant the system is not confirmed. For dose-response evaluations,biological reactivity. PHARMACEUTICAL STABILITY 1150 PHARMACEUTICAL STABILITY. The term “stability,” with respect to a drug dosage form, refers to the chemical and physical integrity of the dosage unit and, when appropriate, the ability of the dosage unit to maintain protection against microbiological contamination. The shelf life of the dosage form is the time lapse from initialSTERILITY TESTS
70 〈71〉 Sterility Tests / Microbiological Tests USP 35 Fluid Thioglycollate Medium is to be incubated at 30°–35°. Table 1. Strains of the Test Microorganisms Suitable for Use in For products containing a mercurial preservative that cannot the Growth Promotion Test and the Method Suitability be tested by the membrane filtration method, Fluid Thiog-Test (Continued) MICROBIOLOGICAL EXAMINATION OF NONSTERILE … Microbial examination of nonsterile products is performed according to the methods given in the texts on Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62.Acceptance criteria for nonsterile pharmaceutical products based upon the total aerobic microbial count (TAMC) and the total combined yeasts and molds count (TYMC) are given in Tables 1 and 2. 2.4.13. SULFATES 2.4.16. TOTAL ASH 2.4.14. SULFATED ASH 2 2.4.13. Sulfates EUROPEAN PHARMACOPOEIA 7.0 01/2008:20413 2.4.13. SULFATES Allsolutionsusedforthistestmustbepreparedwithdistilled water R. Add 3 mL of a 250 g/LMINIMUM FILL
Remove the contents from each container by employing any safe technique (e.g., chill to reduce the internal pressure, remove the valve, and pour). Remove any residual contents with suitable solvents, then rinse with a few portions of methanol. Retain as a unit the container, the valve, and all associated parts, and heat them at 100for 5 minutes.
DETERMINATION OF VOLUME OF INJECTION IN Injections in Cartridges or Prefilled Syringes— Select 1 container if the volume is 10 mL or more, 3 containers if the nominal volume is more than 3 mL and less than 10 mL, or 5 containers if the nominal volume is 3 mL or less. If necessary, fit the containers with the accessories required for their use (needle, piston, syringe) and transfer the entire contents of each container without QUALITY ASSURANCE IN PHARMACEUTICAL … A quality assurance program is a system of steps and actions taken to ensure the maintenance of proper standards in compounded preparations. The need for a quality assurance system is well documented in USP chapters (see Compounding Controls under Good Compounding Practices 1075; Quality Control and Verification under Pharmaceutical Compounding—Nonsterile Preparations 795; and The QualityCASTOR OIL EMULSION
Castor Oil Emulsion. Packaging and storage— Preserve in tight containers. Identification— Shake well, and place about 10 mL in a 125-mL separator. Add 10 mL of 1 N hydrochloric acid and about 20 mL of solvent hexane. Shake vigorously for 2 to 3 minutes, allow the layers to separate, discard the aqueous phase, and filter the upperlayer
TRANSFUSION AND INFUSION ASSEMBLIES AND SIMILAR 128 〈151〉 Pyrogen Test / Biological Tests USP 35 For the rabbit pyrogen test, inject (1/7) of the vial contents for Bacterial Endotoxins, but with volumes of rinse or extrac- per kg of body weight into each rabbit. The maximum dosetion fluid not to exceed 40 mL of sterile saline TS per de- BIOLOGICAL REACTIVITY TESTS, IN VIVO 94 〈87〉 Biological Reactivity Tests, In Vitro / Biological Tests USP 35 (mildly reactive). Repeat the procedure if the suitability oflogical Reactivity Tests, In Vitro 〈87〉 have indicated significant the system is not confirmed. For dose-response evaluations,biological reactivity. PHARMACEUTICAL STABILITY 1150 PHARMACEUTICAL STABILITY. The term “stability,” with respect to a drug dosage form, refers to the chemical and physical integrity of the dosage unit and, when appropriate, the ability of the dosage unit to maintain protection against microbiological contamination. The shelf life of the dosage form is the time lapse from initialSTERILITY TESTS
70 〈71〉 Sterility Tests / Microbiological Tests USP 35 Fluid Thioglycollate Medium is to be incubated at 30°–35°. Table 1. Strains of the Test Microorganisms Suitable for Use in For products containing a mercurial preservative that cannot the Growth Promotion Test and the Method Suitability be tested by the membrane filtration method, Fluid Thiog-Test (Continued) MICROBIOLOGICAL EXAMINATION OF NONSTERILE … Microbial examination of nonsterile products is performed according to the methods given in the texts on Microbial Enumeration Tests 61 and Tests for Specified Microorganisms 62.Acceptance criteria for nonsterile pharmaceutical products based upon the total aerobic microbial count (TAMC) and the total combined yeasts and molds count (TYMC) are given in Tables 1 and 2. 2.4.13. SULFATES 2.4.16. TOTAL ASH 2.4.14. SULFATED ASH 2 2.4.13. Sulfates EUROPEAN PHARMACOPOEIA 7.0 01/2008:20413 2.4.13. SULFATES Allsolutionsusedforthistestmustbepreparedwithdistilled water R. Add 3 mL of a 250 g/L QUALITY ASSURANCE IN PHARMACEUTICAL … A quality assurance program is a system of steps and actions taken to ensure the maintenance of proper standards in compounded preparations. The need for a quality assurance system is well documented in USP chapters (see Compounding Controls under Good Compounding Practices 1075; Quality Control and Verification under Pharmaceutical Compounding—Nonsterile Preparations 795; and The Quality PHARMACEUTICAL STABILITY 1150 PHARMACEUTICAL STABILITY. The term “stability,” with respect to a drug dosage form, refers to the chemical and physical integrity of the dosage unit and, when appropriate, the ability of the dosage unit to maintain protection against microbiological contamination. The shelf life of the dosage form is the time lapse from initialCASTOR OIL EMULSION
Castor Oil Emulsion. Packaging and storage— Preserve in tight containers. Identification— Shake well, and place about 10 mL in a 125-mL separator. Add 10 mL of 1 N hydrochloric acid and about 20 mL of solvent hexane. Shake vigorously for 2 to 3 minutes, allow the layers to separate, discard the aqueous phase, and filter the upperlayer
LOSS ON DRYING
USP 35 Physical Tests / 〈731〉 Loss on Drying317 to within ±20% for multi-element analyses, or when con- as an intensity reference for the analysis. An internal stan-centrations are*
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