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  • Terms

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    Mich Tolentino
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    This document discusses key terms and concepts related to pharmaceutical principles, drug development and regulation, formulation and manufacturing processes, and common solvents. It covers topics like investigational new drugs, new drug applications, drug recalls, stability studies, artificial sweeteners, the Delaney Clause, the Federal Food, Drug and Cosmetic Act of 1938, sterilization methods, and aqueous and non-aqueous solvents including alcohol, glycerin and water.

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    This document discusses key terms and concepts related to pharmaceutical principles, drug development and regulation, formulation and manufacturing processes, and common solvents. It covers topics like investigational new drugs, new drug applications, drug recalls, stability studies, artificial sweeteners, the Delaney Clause, the Federal Food, Drug and Cosmetic Act of 1938, sterilization methods, and aqueous and non-aqueous solvents including alcohol, glycerin and water.

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    © All Rights Reserved
    Baixe no formato DOCX, PDF, TXT ou leia online no Scribd
    Sinalizar o conteúdo como inadequado
    23 visualizações1 página

    Terms

    Enviado por

    Mich Tolentino
    This document discusses key terms and concepts related to pharmaceutical principles, drug development and regulation, formulation and manufacturing processes, and common solvents. It covers topics like investigational new drugs, new drug applications, drug recalls, stability studies, artificial sweeteners, the Delaney Clause, the Federal Food, Drug and Cosmetic Act of 1938, sterilization methods, and aqueous and non-aqueous solvents including alcohol, glycerin and water.

    Direitos autorais:

    © All Rights Reserved
    Baixe no formato DOCX, PDF, TXT ou leia online no Scribd
    Sinalizar o conteúdo como inadequado
    de 1

    Terms.Terms.Terms.Terms.Terms Keywords.Keywords.Keywords.Keywords.

    Keywords
    Pharmaceutical Principlesphysicochemical principles
    Investigational New Drug-protect
    rights and safety of subjects
    New Drug Application-permission to
    market
    Supplemental New Drug
    Application-sponsor
    Abbreviated New Drug
    Application-omit
    Drug Product RecallFDA/Manufacturer
    Voluntary Recall-manufacturer
    Depth of Recall/ Level of market
    removal or correction
    Pharmaceutics
    Master Formula
    Stability
    Stability Studies
    Hydrolysis(Solvolysis)
    Oxidation

    Delaney Clause
    Sucrose
    Saccharin- 1st artificial sweetener,
    1879 Remsen and Fahlberg
    Cyclamate-carcinogenecity (30x
    sweeter
    Aspartame- 1st artificial sweetener
    with Delaney Clause
    Acesulfamepotassium- nonnutritive sweetener (130x
    sweeter)
    Stevia- Stevia rebaudiana, sweet
    leaf (30x)
    Coal Tar (pix carbonis)
    Lakes
    Federal Food, Drug and Cosmetic
    Act of 1938
    15% Alc- acid
    18% Alc- alkali
    Opthalmic and Injectable preps

    Autoclave: 20 mins at 15 lb
    pressure 121C
    Dry Heat 180C 1hr
    Bacterial Filtration

    SOLUTIONS
    Aqueous
    Non-aqueous
    Solvents
    Alcohol USP-94.9%-96%
    Diluted Alcohol- 49%
    Rubbing alcohol-70% ethyl
    alc
    Glycerin USP
    Isopropyl rubbing Alcohol
    70% by volume
    Propylene glycol USP
    WATER
    Purified Water USP-

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