BP & PHARMACEUTICAL ANALYSIS Flashcards
Where do impurities come from?
Raw materials, manufacturing method, decomposition, environment
Which 10 characteristics need to be checked when manufacturing drugs?
Identity, purity, uniformity
Potency, efficacy, toxicity
Packaging, labelling, storing, stability
How do you extract and identify drugs?
UV, IR, TLC, spot test-extraction techniques
How do you standardise reagents?
Volumetric analysis
What Act establishes the legal status of the Pharmacopoeias and compendia?
Human Medicines Regulations 2012, and is covered in Part 15
What requirements do the pharmacopoeias define?
- Quantitative and qualitative composition of medicinal products and pharmaceutical substances
- Tests to be carried out on medicines and substances and other materials used in production
What are the 5 products the European/British Pharmacopoeia cover?
- active substances, excipients & preparations of chemical, animal, human or herbal origin
- homoeopathic preparations and homoeopathic stocks
- antibiotics
- dosage forms and containers
- includes texts on biologicals, blood and plasma derivatives, vaccines and radiopharmaceutical preparations
Which are the 3 pharmacopoeias?
- European Pharmacopoeia
- British Pharmacopoeia (humans only)
- British Pharmacopoeia (veterinary)
The European Pharmacopoeia is under the direction of…
The Council of Europe
The British Pharmacopoeia is under the direction of…
of British Pharmacopoeia Commission Secretariat of MHRA
The BP sits over the European pharmacopoeia. True or false?
False - EP sits over BP
It is legal to sell, supply or dispense a medicinal product whose name is at the head of a monograph in BP, if the product doesn’t comply with the standards specified in that monograph. True or false?
False - it is an offence to do so
What does it mean if a product is labelled BP?
Then the product must conform to standards in the current BP
What does it mean if a product is labelled BP 1963?
The product must conform to standards in the 1963 BP
Name the specified publications under HMRs 2012
- European Pharmacopoeia
- British Pharmacopoeia
- Cumulative List of Recommended International Non-proprietary Names (INN)
Monographs in BP contain all tests that provide verification of the suitability of the product for pharmaceutical use. True or false?
False - contain essential, but not all tests
What does MHRA stand for?
Medicines and Healthcare Products Regulatory Agency
What is in a BP Monograph? (7)
- Description of the product
- Identification tests
- Physical constants (e.g. diffractive index)
- Minimum purity standards
- Assay of active pharmaceutical ingredients
- Limit test (controls impurity levels)
Storage conditions (not always)
In the BP, how should solubility statements in the characteristic section be treated?
They should be treated as guidelines and not official requirements
In the BP, how should solubility statements under heading such as solubility in ethanol be treated?
They should be treated as official requirements
What does soluble in the BP mean?
1g of solute dissolves in 10 to 30ml of solvent
What does slightly soluble in the BP mean?
1g of solute dissolves in 100mL to 1L
What does practically insoluble in the BP mean?
1g of solute dissolves in more than 10L
Are identification tests absolute proof in the BP?
No - they are only used to verify that the identity is according to the label claim
What piece of apparatus does visual comparative tests take place in?
Identical tubes with a flat base tubes (Nessler cylinder)
What are the rules for BP Assays?
Quantity taken for assay must not deviate by more than 10% from that stated
What does the weight have to be accurate to, if you are weighing in accordance to BP rules?
The weight needs to be accurate to +/- 5 units after the last figure (e.g. 0.25g = 0.245 to 0.255g)
When do you use a pipette, volumetric flask or burette to measure a volume?
If the figure after the decimal point is a zero or ends in a zero (for example, 10.0ml or 0.50ml)
When do you use a graduated cylinder or graduated pipette to measure volume?
If the figure after the decimal point is NOT a zero or does not end in a zero
When do you use a micropipette or micro syringe to measure volume?
For volumes stated in microliters
When has a product dried?
When there is +/- 0.5mg diff in weight between two dryings.
What does loss on drying reflect?
The net weight of a pharmaceutical substance under certain specified conditions of heat, pressure and duration.
What is a limit test?
When standards are used to control the presence of toxic impurities.
What is an example of a limit test?
Comparison of colour or turbidity of a prescribed solution against standard solution with known amounts of impurities.
What information does pharmaceutical analysis provide?
Drug ID & purity Stability Shelf-life % content of drug excipient ID impurities ID and concentration If the formulation meets certain specification
