W2 L3 - BP and Pharmaceutical Analysis Flashcards
(21 cards)
What’s British Pharmacopeia
- a book containing directions for the identification of compound medicines
- sets UK standards for medicines
who oversees the BP?
overseen by the MHRA (UK regulatory body)
What must a product labeled “Paracetamol BP” comply with?
All requirements of the relevant BP monograph edition.
What is the European Pharmacopoeia?
A European standard set by the Council of Europe.
What are key contents of a BP monograph?
- Official product name
- Description (physical properties,solubility)
- ID tests
- physical constant (melting point)
- minimum purity/assay requirements
- impurity tests
- storage conditions
Give an example of a purity requirement from a monograph.
Aspirin BP: 99.5–101.0% purity.
What are the goals of pharmaceutical analysis?
Ensure identity, purity, potency, efficacy, and safety of drugs.
Name sources of impurities in drugs.
Raw materials, synthesis, storage, degradation, packaging.
What are the 5 steps of drug analysis?
- Sampling – Choose a representative sample
- Extraction – Isolate analyte from matrix
- Purification – Remove interfering substances
- Characterization – Identify the analyte
- Data Validation – Use statistics or standard comparison
When are micropipettes used?
For volumes <1 mL (microlitre range).
What are Nessler cylinders used for?
- Visual limit tests (e.g., salicylic acid, heavy metals).
- used in visual limit tests to compare the colour intensity of a test solution against a standard solution with a known impurity level.
✅ Stronger color = higher impurity
✅ If test solution is darker than standard → it fails the limit test.
What does “dry to constant mass” mean?
continue drying until weight change is < ±0.5 mg.
Define accuracy.
Closeness to the true value.
Define precision.
Reproducibility; closeness of repeated results.
How is relative standard deviation (RSD) calculated?
RSD= SD/mean x 100
Why use N-1 for SD in small samples?
To correct for bias (degrees of freedom adjustment).
How much can the assay sample deviate from label amount?
No more than ±10%.
Are identification tests in BP definitive proof of a drug’s identity?
No—used to support label claims, not proof.
They are not definitive proof because:
- Multiple compounds may give similar results in certain tests.
- They don’t fully rule out adulterants or lookalikes.
- They’re meant to support that the product matches the label claim, not prove it beyond doubt.
✅ So: They confirm identity within limits, but further tests (like full structural analysis or purity assays) may be needed for complete verification.
What does “soluble” mean in BP terms?
1g dissolves in <30 mL solvent.
What does “slightly soluble” mean?
1g dissolves in 100 mL – 1 L.
What does “practically insoluble” mean?
1g requires >10 L to dissolve.
