TYPE OF WATER
These are several types of waters depending upon their
Quality and Purpose of use. Only some types of waters and defined here for
understanding the terminologies.
1. Drinking or Potable Water:
Means water that is intended for human consumption and
may be sealed in a bottle or other containers with no added ingredients.
Drinking water shall comply with the standard specified by Bureau of Indian
Standard or WHO Drinking Water Standard. Or US potable Water Standard 40 CFR
141 or such other standards. Indian Pharmacopoeia has given 500 CFU/ml limit
for Total Aerobic Microbial Count.
2. Purified Water (IP):
Water prepared by distillation, by means of ion exchange
or by any other appropriate means from suitable potable water that complies all
relevant statutory regulations. Purified water shall comply with standards
given in Monographs of Official Books and Pharmacopoeia – (IP, BP, USP, NF, and
EP Etc).10 CFU/ml Limit for microbial Population may be considered for Purified
Water.
3. Water for Injection (IP):
It is apyrogenic distilled water intended for use in the
preparation of medicines for parenteral administration. When water is used as a
vehicle (water for injection in bulk) and for dissolving or diluting substances
and preparation for injections.
WFI is obtained by distillation potable water or purified
water from a neutral glass, quartz or suitable metal still with an effective
device for preventing the entertainment of droplets. This still must be suitably
maintained to ensure the production of apyrogenic water. The first portion of
distillate is discarded and remainder is collected and stored in conditions
designed to prevent the growth of micro-organism and to avoid any other
contamination. It should comply with the standards given in the monograph of Official
books and Pharmacopoeias.
4. Sterile Water for Injection (IP):
Sterile Water for Injection is water for injection
distributed in suitable containers or glass of other material sealed and
sterilized by heat under conditions that ensures that the water remains
apyrogenic. Each container contains a sufficient amount of WFI to permit the
withdrawal of the nominal volume. It should comply with the standards given in
the monograph of Official books or Pharmacopoeias.
Recommended microbial limit is not more than 10 organisms
per 100 ml and Pathogens should be absent.