Tag Archives: Burgenland

Lubricants and Glidants used in Tablet Formulations

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Tablets Lubricants Lubricants and Glidants used in Tablet Formulations are: • Magnesium stearate • Stearic acid • Sodium stearyl fumarate • Hydrogenated vegetable oil • PEG 4000, 6000 • Hexagonal boron nitride • DL-Leucine • Sodium lauryl sulfate • Gliceryl behenate • Sodium benzoate • Colloidal silicone dioxide • Talc …

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Pharmaguidances Whats App Groups

Pharmaguidances Whats App Groups Pharmaguidances   Pharma Post and Jabs     Pharma Vacancy Pharma Post and Jabs 2   Pharmaguideline   Pharmaguideline 2           MFR of SALBUTAMOL SULPHATE TABLET

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Preformulation stability studies

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Stability Analysis Preformulation stability studies are the first quantitative assessment of chemical stability of a new drug. This may involve 1. Stability study in toxicology formulation 2. Stability study in solution state 3. Stability study in solid state. Stability Study in Toxicology Formulation: A new drug is administered to animals …

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Powder Particle Size Determination Methods for tablets

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Particle Size Determination Methods: 1. Sieving 2. Microscopy 3. Sedimentation rate method 4. Light energy diffraction 5. Laser holography 6. Cascade impaction 1. Sieving method: • Range: 50 – 150 μm • Simple, inexpensive • If powder is not dry, the apertures get clogged. 2. Microscopy: • Range: 0.2 – …

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Powder flow properties in Pharmaceuticals

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Powder flow properties in Pharmaceuticals Apparent bulk density (g/cm3): Bulk drug powder is sieved through 40 mesh screen. Weight is taken and poured into a graduated cylinder via a large funnel. The volume is called bulk volume. Apparent bulk density = Weight of the powder/Bulk volume Tapped density (g/cm3): Bulk …

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TABLET TOOLING

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TABLET TOOLING Basics of Tablet Tooling Tablet compression machines are made keeping in view the type of dies and punches will be used on them. The dies and punches and their setup on compression machine is called tooling, it is classified as B and D mainly. The B tooling dies …

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Preformulation for Tablets, Capsules, Liquid Orals

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Preformulation for Tablets, Capsules, Liquid Orals Before developing a formulation like tablets, capsules, liquid orals we study the suitability of new drug or drug and excipients for the chosen formulation which is called preformulation. Preformulation Definition Preformulation may be defined as a stage of the research and development process where …

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Pharmaceutical Quality Assurance -Drug and Therapeutics Committee Training Course

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Pharmaceutical Quality Assurance -Drug and Therapeutics Committee Training Course CONTENTS Pharmaceutical Quality Assurance Acknowledgment Purpose and Content Objectives Outline Key Definitions Introduction Determinants or Aspects of Medicine Quality Critical Elements of a Comprehensive Quality Assurance Program How Is Quality Assessed? How Is Quality Assured? Who Ensures Medicine Quality? Pharmaceutical Quality …

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MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE AS PER INTERNATIONAL PHARMACOPOEIA

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MONOGRAPH ON LIQUID PREPARATIONS FOR ORAL USE AS PER INTERNATIONAL PHARMACOPOEIA Definition Liquid preparations for oral use are usually solutions, emulsions or suspensions containing one or more active ingredients in a suitable vehicle, they may in some cases consist simply of a liquid active ingredient used as such. Liquid preparations …

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SOP on Testing Efficacy of Disinfectants

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SOP on Testing Efficacy of Disinfectants. Objective: To lay down a procedure for testing efficacy of Disinfectants. Scope : This SOP is applicable for testing of efficacy of disinfectant solutions used in  microbiology laboratory and production area. Responsibility Microbiologist Head-Microbiology Accountability Head-Quality Control Head-Quality Assurance Procedure Prepare Culture suspension of …

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Lorazepam Aristo 2.5 mg tablets

Lorazepam Aristo 2.5 mg tablets Active ingredient – lorazepam Legal Category : POM: Prescription only medicine 1. Name of the medicinal product Lorazepam Aristo 2.5 mg tablets 2. Qualitative and quantitative composition One tablet contains 2.5 mg lorazepam. Excipients with known effect Each tablet contains 116.7 mg lactose (as lactose …

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Aciclovir 400 mg Tablets

Aciclovir 400 mg Tablets Active ingredient – Aciclovir Legal Category -POM: Prescription only medicine 1. Name of the medicinal product Aciclovir 400 mg Tablets 2. Qualitative and quantitative composition Each 400 mg tablet contains 400 mg aciclovir. For the full list of excipients, see section 6.1 3. Pharmaceutical form Tablet …

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Furosemide 40 mg Tablets

Furosemide 40 mg Tablets Active ingredient – Furosemide Legal Category – POM: Prescription only medicine 1. Name of the medicinal product Furosemide 40mg Tablets 2. Qualitative and quantitative composition Each tablet contains Furosemide 40mg. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Tablet White to off white, …

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SOP on Personnel Qualification for Aseptic Processing and Sterility Testing Area

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Personnel Qualification for Aseptic Processing and Sterility Testing Area Objective: To lay down the procedure for Personnel Qualification to enter and work in the Aseptic Processing area and Sterility Testing Area. Scope: This SOP is applicable for Personnel Qualification to work in Aseptic Processing and Sterility testing Area Procedure: For …

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SOP on Personnel Qualification for Aseptic Processing and Sterility Testing Area

Objective: To lay down the procedure for Personnel Qualification to enter and work in Aseptic Processing area and Sterility Testing Area. Scope: This SOP is applicable for Personnel Qualification to work in Aseptic Processing and Sterility testing Area. Responsibility: Chemist or above of Microbiology Laboratory. Head – Microbiology Section. Accountability: …

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SOP on Viable Particle Monitoring of Drain Points– Sterile Product Manufacturing Facility

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Objective: To lay down the procedure for Viable Particulate Monitoring of Drain Points – Sterile Product Manufacturing Facility Scope: This SOP is applicable for Viable Particle Monitoring of Drain Points – Sterile Product Manufacturing Facility Responsibility: Officer or above of Microbiology Laboratory. Head – Microbiology section / Nominee. Accountability: Head …

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SOP on calibration of pH meter

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Objective: To lay down a procedure for calibration of pH Meter. Scope: This SOP is applicable for calibration of pH Meter in quality control laboratory. Responsibility: Officer or above of QC laboratory is responsible for calibration of pH Meter Head Quality / nominee of QC department is responsible for reviewing …

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Aceclofenac 100 mg Film-coated Tablets

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Aceclofenac 100 mg Film-coated Tablets 1. Name of the medicinal product Aceclofenac 100 mg Film-coated Tablets 2. Qualitative and quantitative composition Each film-coated tablet contains 100 mg of aceclofenac For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet. White, round, biconvex film-coated tablets, 8 mm …

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Q7 GMP Guidance for Active Pharmaceutical Ingredients

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 Guidance for Industry II. QUESTIONS AND ANSWERS A. Scope (1) 1.1: Should GMP according to ICH Q7 be applied for manufacturing steps before the defined API starting material, i.e., steps not identified in grey in Table 1? ICH Q7 does not apply to steps prior to the introduction of the …

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Actelsar HCT tablets

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Actelsar HCT tablets 1. Name of the medicinal product Actelsar HCT 40 mg/12.5 mg tablets Actelsar HCT 80 mg/12.5 mg tablets 2. Qualitative and quantitative composition Actelsar HCT 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide. Actelsar HCT 80 mg/12.5 mg tablets Each tablet …

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