Quality-by-Design Principles Applied to the Establishment of a Pharmaceutical Quality Control Laboratory in a Resource-Limited Setting: The Lab Water

Table 3

Typical analytical quality results of water R according to Ph. Int.

#	Test	Specification limit	Compliance (√)/noncompliance (x)
			Ultrapure water	Distilled water	Tap water
1	Heavy metals	Color not darker than the same untreated purified water	√	√	x
2	Ammonia	Color of test solution is not more intense than standard solution	√	√	√
3	Calcium and magnesium	Pure blue color	√	√	√
4	Chlorides	Clear and colorless	√	√	√
5	Nitrates	No blue color appeared at the interface of the two liquids	√	√	√
6	Sulfates	Clear and colorless	√	√	√
7	Oxidizable matter	Faintly pink test solution	√	√	√
8	Nonvolatile residue	<0.001%	√	√	X
9	Alkalinity/acidity	No red color up on addition of methyl blue and no blue color appears up on addition of bromothymol blue	√	√	√

After cleaning.