BP & Pharm Analysis

Question 1

What is the purpose of BP?

Answer 1

Ensure QUALITY, SAFETY AND EFFICACY of meds

- Defines requirements for composition of meds and tests

Question 2

Important characteristics of Meds?

Answer 2

• PURITY, UNIFORMITY, POTENCY, EFFICACY, TOXICITY, PACKAGING, STORING, STABILITY , LABELLING

Question 3

BP Monographs?

Answer 3

ID tests,
Ingredients
Impurity level tests
Physicals constants E.g BP MP

Question 4

What does SOLUBLE mean in BP?

Answer 4

1g in <30ml

Question 5

What does SLIGHTLY SOLUBLE mean in BP?

Answer 5

1g in <100ml

Question 6

What does PRACTICALLY INSOLUBLE mean?

Answer 6

1g in >10L

Question 7

Are ID tests absolute proof?

Answer 7

NO- E.g. in IR spectra compare the mains peaks, not all

Question 8

Visual tests can be done through?

Answer 8

Nessier cylinder- view from the top

Question 9

Quantities taken for assay must not deviate ___?

Answer 9

> 10%

Question 10

Weighing accuracy must be ____?

Answer 10

+/- 5 units AFTER the last digit E.g. 0.25 = 0.245 or 0.255

Question 11

When to use a pipettes / volumetric flask / Burette.?

Answer 11

If figure after decimal = 0 / figure ends on 0

Question 12

How much difference can be between 2 dryings?

Answer 12

+/- 5mg difference in weight between 2 dryings

Question 13

What information can be gathered from analysis?

Answer 13

Stability
Drug ID 
Purity 
Shelf life
% content of drug 
ID of excipients

Question 14

The % content of API must remain ____?

Answer 14

Within 99% to 101%