API’s

Question 1

What testing would you expect for an API?

Answer 1

Appearance - Visual
Identification - HPLC / UV
Assay - HPLC
Related Substances - HPLC
Particle Size - Sieving / X-Ray Diffraction.
Water Content / Loss on Drying- Karl Fisher
Residual Solvents - GC
Residual Catalysts

Question 2

During API manufacture what methods are there for purification?

Answer 2

Distillation
Crystallisation
Extraction
Washing
Centrifuge

Question 3

API’s must be manufactured in accordance with ?

Answer 3

Part II EU GMP, ICH Q7, 1252 /2014, Distributed to 2015/C95/01

Question 4

What is a CEP vs DMF?

Answer 4

Certificate of Conformance to the European Pharmacopeia - demonstrates equivalence.

DMF - Drug Master File

Question 5

Typical Manufacturing Controls for an API

Answer 5

ICH Q7 GMP Part II

Temperature
Pressure
Agitator Speed / Time
Rate of Addition
API Powder - Drying Conditions

Question 6

What are the key Manufacturing Steps in API Production?

Answer 6

Dispensing
Mixing
Chemical Reactions
Extraction
Purification
Drying
Particle Size / Micronisation
Filling
Packing

Question 7

What are the main risk factors when assessing Nitrosamines?

Answer 7

Synthesis Routes
Use / Re-Use of Solvents
Starting Materials
Packaging Materials

Question 8

What are the contents of a CEP?

Answer 8

Name of Manufacturer
Intermediates
Sterilisation details (If Applicable)
Impurities
Max Daily Dose Values
Residual Solvents
Container Closure
Water Quality
Micro Quality