reports

• Tablets


  Solid dosage forms, containing medicinal substances with or without suitable diluents
• Tests for tablets


  • Non-official test
  • Official test
  • Appearance/Description
  • Identification test
  • Thickness and diameter
  • Friability test
  • Hardness
  • Disintegration test
  • Organoleptic properties
  • Weight variation test
  • Uniformity of dosage unit test
  • Dissolution test
  • Assay test
  • Impurity test
• Appearance/Description


  The appearance of a drug product can include its color, shape, size, odor, and other physical attributes
• Thickness and diameter


  1. Determine least count of vernier calliper

  2. Place tablet between measuring jaws and record main scale and vernier scale reading

  3. Measure thickness for ten tablets

  4. Complete the calculations and calculate average thickness for tablet

  5. Calculate 5% deviation from average thickness

  6. Calculate range and check whether individual thickness of tablet lies in it
• Hardness


  A force required to break a tablet in a diametric compression test
• Hardness test


  1. Place the tablet diametrically on fixed anvil of the Monsanto hardness tester

  2. Rotate the top screw of the tester so as to tablet holds between fixed and moving anvil of tester

  3. Adjust the scale suitably to zero

  4. Again rotate top screw of the tester so as to pressure gets applied on tablet

  5. Continue the rotation of screw till tablets breaks
• Organoleptic properties


  • Color is crucial for identification and patient acceptance
  • Odor is important for patient acceptance, especially for ODT tablets, and chewable tablets
  • Taste is important for patient acceptance, especially for ODT tablets, chewable tablets, and dispersible tablets
• Identification test


  Used to verify the identity of the active pharmaceutical ingredient (API) in the dosage form
• Friability test


  Measures the tendency of a tablet to chip, break or crumble after compression, physical shock or abrasion during manufacturing, packaging, shipping or handling
• Friability test


  1. Collect paracetamol tablets, dedust and check individual weight

  2. If weight of one tablet less than 650 mg then take a sample of whole tablet corresponding to weigh 6.5 g. Record the weight of tablets as W0

  3. Place the tablets in drum and fix it to friabilator

  4. Operate the friabilator for 100 revolutions

  5. Once again remove drum and dedust tablets

  6. Check tablets for capping, lamination and chipping

  7. Again take weight for tablets and record it as W1

  8. Calculate the percent friability
• Disintegration test


  The process by which a solid oral dosage form such as tablet breaks down into small particles
• Uniformity of dosage unit test

  The degree of uniformity in the amount of the drug substance among dosage units
• Uniformity of weight (mass) of tablet

  A weight variation test is performed to determine the consistency of formulated preparations
• Dissolution test


  Measures the extent and rate of solution formation from a dosage form such as tablet, capsule, ointment, etc. It is important for its bioavailability and therapeutic effectiveness
• Assay testing


  An analysis used to determine the presence of a particular substance and its concentration
• Impurity test


  Crucial to provide purity, safety and quality control for APIs and drug products. Pharmaceutical impurities may come from different sources, such as starting materials, reagents, solvents, intermediates, degradation products and excipients and can be both of organic and inorganic origin
• Semi-solid


  A type of medication that is neither solid nor liquid. These medications are applied to the skin, nasal mucosa, rectal or vaginal tissue
• General tests for semi-solids

  • Identification test
  • Assay of active ingredients
  • Uniformity of dosage unit
  • pH measurement
  • Consistency evaluation
  • Homogeneity test
  • Appearance evaluation
  • Microbial limit test
  • Sterility test
  • Stability test
• Identification test for semi-solids

  Used to verify the identity of the active pharmaceutical ingredient (API) in the dosage form
• Identification test for semi-solids

  1. Sample preparation: Dissolve a specified amount of the semi-solid dosage form in a suitable solvent

  2. Chromatographic methods

  3. Spectroscopic methods
• Assay of active ingredients

  Determines the strength or content of the API in the dosage form
• Assay of active ingredients

  1. Sample preparation: Accurately weigh and dissolve the sample in a suitable solvent

  2. HPLC: Inject the sample solution into an HPLC system using a validated method

  3. Mobile phase: Use an appropriate mobile phase for the API

  4. Detection: Use UV detection or another suitable detector to quantify the API
• Uniformity of dosage unit

  A weight uniformity test in which the weight of liquid in individual containers is weighed and an acceptance value is calculated
• Uniformity of dosage unit

  1. Weight variation: Weigh each individual unit of the semi-solid dosage form

  2. Content uniformity: Determine the amount of API in each unit using an appropriate analytical method, such as HPLC
• pH measurement


  A test that can determine how acidic or basic a substance is
• pH measurement


  1. Sample preparation: Dissolve or disperse the sample in water or a specified buffer

  2. Measurement: Measure the pH using a calibrated pH meter
• Consistency evaluation


  Designed to assess one necessary, but not sufficient, aspect of robustness. That is, the ability to find the same solution regardless of the initial position
• Consistency evaluation


  Penetrometer: Measure consistency
• Homogeneity test


  Ensures that the preclinical dose formulation contains active ingredient(s) uniformly throughout the formulation, thereby ensuring that the test system is being administered using the appropriate amount of test material
• Homogeneity test


  Sampling: Collect samples from different parts of the batch and observe
• Appearance evaluation


  Tests to measure irritancy for ointments, and tests of rheology, sensitivity, and biological activity for ointments
• Appearance evaluation


  1. Visual inspection: Assess color, texture, and phase separation

  2. Additional tests: Perform tests for drug irritancy for ointments, and rheology
• Microbial limit test


  Performed to assess how many and which of certain viable microorganisms are present in non-sterile pharmaceutical, healthcare or cosmetics manufacturing samples that range from raw materials to finished products
• Microbial limit test


  1. Sample preparation: Sampling plan

  2. Preparation of initial suspension: Weighing, homogenization, and blending

  3. Plating: Media, plating, incubation, and counting

  4. Interpretation and results
• Sterility test


  Designed to demonstrate the presence or absence of extraneous viable contaminating microorganisms in biological parenterals designed for human use
• Sterility test


  1. Sample preparation: Aseptic handling and sample size

  2. Selection of media and incubation conditions

  3. Method A - Membrane filtration: Sample preparation, filtration, rinsing, incubation

  4. Method B - Direct inoculation: Incubate the inoculated media for NLT 14 days, observe the cultures several times during the incubation period

  5. Observation and interpretation of results

  6. Control tests

  7. Documentation and reporting
• Stability test


  Process by which drug manufacturers collect data on their product over predetermined lengths of time in specific environmental conditions to determine if there is any change in the quality of the Active Pharmaceutical Ingredient (API) or Final Product (FP)
• Stability test


  1. Preparation of the sample: Batch selection and packaging

  2. Stability testing protocol: Stability plan, test conditions and time points

  3. Storage conditions: Long term testing, accelerated testing, intermediate testing

  4. Test parameters: Physical characteristics, chemical characteristics, microbial limits, functional testing

  5. Sampling and testing: Initial testing, periodic testing, testing frequency

  6. Documentation and reporting

  7. Regulatory compliance
• Suspension


  A heterogeneous system consisting of two phases in which internal phase is dispersed uniformly throughout the external phase
• Classification of suspensions


  • Based on physical state: Suspension, aerosols, foams
  • Based on proportion of solid particles: Dilute suspension, concentrated suspension
  • Based on behavior of dispersed phase: Flocculated suspension, deflocculated suspension
  • Based on size of dispersed particles: Molecular dispersion, colloidal dispersion, coarse dispersion
  • General classification: Oral suspension, topical suspension