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Define “thermogravimetric analysis”
a technique in which the mass of a substance is monitored as function of temperature or time as the sample specimen is subjected to a controlled temperature program in a controlled atmosphere
measures a sample’s weight as it is heated or cooled in a furnace
What gases provide the controlled atmosphere in TGA?
air
N2
CO2
He
Ar
How is the weight change against temperature during TGA plotted? (what is the name)
thermogram OR thermogravimetric curve
What are the major components of TGA instrumentation?
furnace
furnace controlled thermo-balance
recorder
Who are the major manufacturers of TGA instrumentation?
Perkin Elmer
Shimadzu
Hitachi
What are the main applications of TGA? (what is it used for)
determination of moisture & volatile content
degradation temperature
ash/residue value
(T/F) TGA only observes weight loss.
False — it observes weight change overall, including loss and gain
How can weight loss occur in TGA?
decomposition — breakdown of chemical bonds
evaporation — loss of volatiles and moisture
reduction — sample interactions with a reducing environment (atmospheric hydrogen)
Define “decomposition”
breakdown of chemical bonds
Define “evaporation”
loss of volatiles and moisture
Define “reduction”
sample interactions with a reducing environment (atmospheric hydrogen)
How can weight gain occur in TGA?
oxidation — sample interactions with an oxidizing environment (atmospheric oxygen)
Define “oxidation”
sample interactions with an oxidizing environment (atmospheric oxygen)
What are the categories of factors that affect thermograms?
instrumental factors
sample characteristics
What types of instrumental factors can affect thermograms?
furnace heating rate
temperature at which a compound decomposes depends directly upon the heating rate
generally a lower heating rate (around 5C per minute) provides a higher resolution
furnace atmosphere
furnace atmosphere has profound effects on the decomposition behavior of a sample
pure nitrogen is commonly used for an inert environment
What gas is used to create an inert environment in TGA?
pure nitrogen (N2)
What types of sample characteristics can affect thermograms?
weight of the sample
smaller sample yields better resolution as it eliminates temperature gradients within the sample
sample particle size
smaller particle size with a uniform distribution is recommended for minimal temperature fluctuations
What instrument did we use for the TGA lab?
Perkin Elmer TGA 4000
What is the USP chapter for the TGA lab? (name and number)
<891> Thermal analysis
Is TGA a good method to determine the various hydrate forms of an ingredient?
TGA is a very effective and widely used method for characterizing different hydrate forms of an ingredient, especially when combined with other techniques for confirmation. It provides both qualitative and quantitative data on how much water is present and the temperatures at which it is released, making it a strong analytical tool for studying hydrates.
Is TGA analysis a good analytical method for water determination versus “Loss on Drying” or “Karl Fischer Titration?”
If water determination is the primary goal and high specificity is required, Karl Fischer Titration is the best choice. TGA and LOD can provide useful estimates, but they are less specific, and the results may include other volatile components along with water.
TGA: Useful for multi-purpose analysis (e.g., thermal decomposition and moisture), but less specific for water determination. It is good for solid samples where moisture and other thermal behaviors are of interest, but not ideal when precise water measurement is required.
LOD: Simple, widely used for approximate moisture content, but also not specific for water since it measures total volatile loss.
Karl Fischer Titration: The gold standard for precise water determination, especially when accuracy and specificity are required. It’s ideal for pharmaceuticals, oils, plastics, and other materials where knowing the exact water content is critical.
What was the topic of the student presentation? (Jasmine, Isabella, Abby, and Emma)
21 CFR 210 — Current Good Manufacturing Practices (cGMP) in Manufacturing Processing, Packing, or Holding of Drugs (general)
What is the Code of Federal Regulations?
The codification of the general and permanent rules published in the Federal Registrar by the departments and agencies of the Federal Government
What are the subparts of 21 CFR 210?
210.1 — status of current good manufacturing practice regulations
210.2 — applicability of current good manufacturing practice regulations
210.3 — definitions
Why is the status of cGMP regulations regulated? (purpose of regulation)
to establish baseline standards for ensuring drug safety, quality, and effectiveness
To confirm the drug has the correct identity, strength, quality, and purity
Who needs to follow cGMP regulation standards?
Methods used in manufacturing, processing, packing, or holding of a drug for both domestic and foreign firms supplying drugs for U.S. distribution
Facilities or controls used in these processes
What types of products/materials does 21 CFR 210 cover?
finished pharmaceuticals
bulk drug substances
components of drugs for human and veterinary use
(T/F) If a person engages in only certain operations subject to regulations in one part but not in another, they need to comply only with the regulations relevant to their specific operation.
True
What are the consequences of not complying with cGMP regulations?
the drug is considered “adulterated”
both the drug and the responsible person/manufacturer will face regulatory action
Define “adulterated”
Containing impurities or harmful substances, often due to improper handling or contamination during production, which can compromise safety, efficacy, or quality of a product
What other parts of the CFR Title 21 supplement Part 210?
211 (Current Good Manufacturing Practice for Finished Pharmaceuticals)
225 (Current Good Manufacturing Practice for Medicated Feeds)
animal drugs
226 (Current Good Manufacturing Practice for Type A Medicated Articles)
animal drugs
600-680 (biological products)
1271 (human cell/tissue-based products)
What types of drugs are exempt from 21 CFR 211 regulations, and what else are they expected to follow?
Investigational drugs for phase 1 studies
subject to 21 U.S.C. 351 (a)(2)(B)
What is 21 U.S.C. 351 (a)(2)(B)?
refers to a drug that must be manufactured, processed, packed, or held using methods, facilities, and controls that conform to cGMP. It also needs to meet safety requirements, and has correct identity, strength, quality, and purity
(T/F) If an investigational drug for phase 1 studies does not meet cGMP standards, they are still able to satisfy 21 U.S.C. 351 (a)(2)(B), it just may be a different way.
False — Non-conformity with cGMP results in the drug not meeting these standards.
When are investigational drugs not exempt from 21 CFR 211 regulations?
once the drug is used in phase 2 or 3 studies or if it has been lawfully marketed.
In such cases, compliance with part 211 is required for the phase 1 study drug
Define “active ingredient”
any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation
Define “inactive ingredient”
any component other than an active ingredient
Define “batch/lot”
a specific quantity of a drug or other material that is intended
to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture
Define “lot/batch number”
any distinctive combination of letters, numbers, or symbols, or any combination of them, from which the complete history of the manufacture, processing, packaging, holding and distribution of a batch or lot of drug product or other material can be determined
What does GLP stand for?
Good Laboratory Practices
What does GCP stand for?
Good Clinical Practices
What does GMP stand for?
Good Manufacturing Practices
What are the different types of GXPs documentation?
GLP — good laboratory practices
GCP — good clinical practices
GMP — good manufacturing practices
regulatory compliance
Enforcement Code of Federal Regulations
What does SOP stand for?
Standard Operating Procedure
What is a Standard Operating Procedure?
step-by-step how-to instructions
instructional resource without asking for directions
What is the importance of SOPs?
being able to perform the task in a consistent manner
What does MBR stand for?
manufacturing batch record
What is a manufacturing batch record?
a complete product history, including the raw materials and equipment used, procedures followed, and quality records
What is the importance of a MBR?
a high-quality batch record is crucial for verifying the quality of the pharmaceutical product
(T/F) Manufacturing batch records are only available as hard-copy templates that are written in.
False — online/electronic batch records are available too
(T/F) Every patient deserves drugs that are safe and efficacious.
True
What is the key value for any manufacturer of (bio)pharmaceuticals?
quality
Describe a typical manufacturing workflow and release
master batch formula is created and finalized
using MBF, manufacturing batch record is made
batch number is issued and manufactured
sampling is performed by quality inspectors
quality control laboratory (QC)
quality assurance (QA)
certificate of analysis and batch release
product is marketed and money is made
Define “batch number”
unique identifier that is crucial for tracking, quality control, and ensuring traceability in pharmaceutical drug development. It helps in monitoring the production process and managing recalls if necessary.
What is the difference between quality control and quality assurance?
quality assurance: focuses on processes and systems to prevent defects and ensure standards are met throughout production; ensures quality requirements are fulfilled; PROACTIVE
quality control: emphasizes inspection and testing of final products to identify and rectify defects after production; ensures medications are safe and effective; REACTIVE
What type of tests do quality control scientists do?
analytical tests and specifications
What type of tests do quality assurance scientists do?
review batch manufacture process and analytical data
Who performs the sampling in a typical manufacturing workflow and release?
quality inspectors
(T/F) Drug substance and API are two different things.
False — they are the same
Define “drug product/dosage form”
combination of API and excipients to facilitate dosing, administration, and delivery of a medicine to the patient
List examples of dosage forms (general)
oral
injection
topical
inhalation
List examples of oral dosage forms
SOLIDS
tablets
capsules
granules
powders
LIQUIDS
solutions
suspensions
emulsions
What are the different possible functions of excipients?
diluents/fillers
binders
disintegrants
lubricants
glidants
surfactants/wetting agents
Define “pharmaceutical excipients”
inert substance that helps form a vehicle for the API
additives used to convert API into actual dosage forms
What does the combination of an API and excipients facilitate?
dosing
administration
delivery
What is the function of filler/diluent excipients?
provide bulk & impart powder characteristics
What is the function of binder excipients?
bind and hold the drug product together —> aid in granulation of fine powders for tablets
What is the function of disintegrant excipients?
promotes capsule plug or tablet disintegration into smaller fragments
What is the function of lubricant excipients?
reduce friction and help tablet ejection from manufacturing lab (so it doesn’t stick to the mold during compression)
What is the function of glidant excipients?
increase powder flow properties (helps it go through the equipment pipes)
What is the function of surfactant/wetting agent excipients?
improve wettability/solubility of API
What are examples of filler/diluent excipients?
microcrystalline cellulose
lactose
starch
CaPO4
What are examples of binder excipients?
Hypromellose
povidone
starch
natural gums
maltodextrins
What are examples of disintegrant excipients?
sodium starch glycolate
croscamellose sodium
crospovidone
What are examples of lubricant excipients?
magnesium stearate
talc
stearic acid
sodium stearyl fumarate
calcium stearate
What are examples of glidant excipients?
(fumed) silica
talc
What are examples of surfactant/wetting agent excipients?
sodium lauryl sulfate
tweens
poloxamers
What type of excipient is microcrystalline cellulose?
filler/diluent
What type of excipient is lactose?
diluent/filler
What type of excipient is starch?
diluent/filler & binder (multi-functional)
What type of excipient are sugars?
diluent/filler
What type of excipient is dicalcium phosphate?
diluent/filler
What type of excipient is hypromellose?
binder
What type of excipient is povidone?
binder
What type of excipient are natural gums?
binder
What type of excipient are maltodextrins?
binder
What type of excipient is sodium starch glycolate?
disintegrant
What type of excipient is croscamellose sodium?
disintegrant
What type of excipient is crospovidone?
disintegrant
What type of excipient is magnesium stearate?
lubricant
What type of excipient is talc?
lubricant & glidant
What type of excipient is stearic acid?
lubricant
What type of excipient is sodium stearyl fumarate?
lubricant
What type of excipient is calcium stearate?
lubricant
What type of excipient is (fumed) silica?
glidant
What type of excipient is sodium lauryl sulfate?
surfactant/wetting agent
What type of excipient are tweens?
surfactant/wetting agent
What type of excipient are poloxamers?
surfactants/wetting agents
What is the BCS classification of piroxicam?
Class II
Define “biopharmaceutical classification system”
A framework that classifies pharmaceutical compounds into four categories based on their permeation and solubility characteristics
helps predict the oral bioavailability of drugs and guides formulation development and regulatory assessments