Preservatives

Question 1

What the method used to evaluate preservatives

Answer 1

Challenge test

Question 2

Challenge test is carried out to assess the activity at which stage?

Answer 2

With product in final container

Question 3

What are the test bacterial sample used
Fungal
Osmophilic yeast

Answer 3

P. Aeruginosa, s. Aureus, E.coli

Aspergillosis niger (mould) Candida albicans

Zygosaccharomyces rouxii

Question 4

What does the NR and NI stand for in Criteria of acceptance E.P

Answer 4

NR: no recovery: <100 organisms per gram or ml of product (parental, ophthalmic)

NI: no increase: < 1/2 log increase since last value given for VC (if VC=1000cfu/ml, the end product’s VC must be <10^3.5 Cfu/ml)