Medicine: BP&Pharmaceutical Analysis Flashcards
Name 4 sources of impurities
Raw materials, manufacturing method, decomposition, environment
Name the 10 important characteristics to check regarding making drugs
identity, purity, uniformity (monograph)
Potency, efficacy, toxicity,
Packaging, labelling, storing, stability
The pharmacopoeias and compendia are under which bit of law?
Human Medicines Regulations (HMR) 2012
Part 15
What does the Human Medicines Regulations (HMR) 2012 contain?
official (British or European) medicinal products and pharmaceutical substances
The European/British Pharmacopoeia defines requirements for…
Qualitative and quantitative composition of medicines
and
Tests to be carried out of medicines and on substances and materials used in their production
What substances does the European/British Pharmacopoeia cover?
- active substances, excipients and preparations of chemical, animal, human or herbal origin
- homeopathic preparations and stocks
- antibiotics
- dosage forms and containers
- includes texts on biological, blood and plasma derivatives, vaccines and radiopharmaceutical preparations
Name 3 Pharmacopoeias
European Pharmacopoeia (EP) British Pharmacopoeia (BP) British Pharmacopoeia (Veterinary) - published as companion volumes to BP
The European Pharmacopoeia is under the direction of…
Council of Europe
The British Pharmacopoeia is under the direction of..
British Pharmacopoeia Commission Secretariat of MHRA
The British Pharmacopoeia is the only offical source of…
British pharmaceutical standards
British Pharmacopoeia comprises of….what 2 things?
1) Substances used in the practice of medicine (not veterinary)
2) Substances and articles used in the manufacture of (1)
Which takes precedence, European Pharmacopoeia or British Pharmacopoeia?
European
If a product is labelled BP, then it must conform with the standards specified in that monograph.
Name an offence(s) regarding this
to sell, supply or dispense a medicinal product of a particular name (if that name is at the head of a monograph in a pharmacopoeia) and the product does not comply with the standards specified in he monograph
Name the specified publications under HMRs 2012
- European Pharmacopoeia
- British Pharmacopoeia
- Cumulative List of Recommended International Non-proprietary Names (INN)
INN=
BP+EP
MHRA=
Medicines and Healthcare products Regulatory Agency
BP originated in what year?
1864
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
Describe solubility statements in..
1) Characteristics section
2) Under headings such as Solubility in ethanol
1) Just a guideline and not official requirement
2) official requirement
Identification tests.. are hey absolute proof or not?
Not
Visual comparative tests take place in?
Identical tubes with a flat base
Nessler cylinder
Rules for BP Assays?
Quantity taken for assay must not deviate by more than 10% from that stated
Weighing needs to be to what accuracy?
+/- 5 units after the last figure
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
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 ends in a zero
Loss on drying reflects what?
The net weight of a pharmaceutical substance under certain specified conditions of heat, pressure and duration.
What does drying to a constant mass imply?
+/- 0.5mg difference in weight between two dryings
What is a limit test?
When standards are used to control the presence of toxic impurities.
Give an example of a limit test
Comparing colour or turbidity of a prescribed solution against a standard solution with known amounts of impurities
