Test to be consider for monitering of warer quality.

Monitoring of water for injection

Specific Test	Guideline
	USP	EP
Appearance	NA	Clear Colorless
BET	Less than 0.25 EU/mL	less than 0.25 IU/mL
Conductivity	As per Table given in respective Monograph	As per Table given in respective Monograph (below table given for reference only )
pH	pH 5.0-7.0	pH 5.0-7.0
TOC	500 ppb	Max. 0.5 mg/L
Microbiological monitoring	Action level 10 cfu/100mL (sample vol-100mL, membrane filtration method, minimum 30-35° for 48-72 hrs)	R2A (Sample volume 200 mL, Action level 10cfu/100mL, incubation condition not less than 5 days at 30-35°C)
Nitrate	NA	Max. 0.2 ppm

EP  Table for WFI

Monitoring of Pure Steam condensate

Specific Test	Guideline
	USP	EP
Appearance	NA	--
BET	Less than 0.25 EU/mL	--
Conductivity	As per Table	--
pH	pH 5.0-7.0	--
TOC	500 ppb	--
Microbiological monitoring	Action level 10 cfu/100mL (sample vol-100mL, membrane filtration method, minimum 30-35° for 48-72 hrs)	--
Nitrate	NA	--

Monitoring of Purified water

Specific Test	Guideline
	USP	EP	Schedule M
Appearance	NA	Clear colorless	NA
BET	NA	NA	NA
Conductivity	As per Table given in respective Monograph	As per Table given in respective Monograph (below table given for reference only )	NA
pH	pH 5.0-7.0	pH 5.0-7.0	NA
TOC	500 ppb	0.5 mg/L (Alternate oxidizable test)	NA
Microbiological monitoring	Action level 100 cfu/mL, sample volume 1 mL, pour-plate method or membrane filtration method, minimum 48-72 hrs. 30-35°C	R2A (Sample volume 10 mL, Action level 100cfu/mL, incubation condition not less than 5 days at 30-35°C)	100 cfu/mL, Pathogen testing-E.coli, S.aureus, Salmonella and p.aeruginosa-absence
Nitrate	NA	Max. 0.2 ppm	NA
Heavy metal	NA	Max. 0.1 ppm if conductivity 1.3ms/cm

EP  Table for Purified water

Note: Please verify  above details with respective Pharmacopeal monograph/Guideline/regulation.

Monitoring of Potable water

Specific Test	Guideline
	Schedule M
Appearance	NA
BET	NA
Conductivity	NA
pH	NA
TOC	NA
Microbiological monitoring	Not more than 500cfu/mL, Pathogen testing-E.coli, S.aureus, Salmonella and p.aeruginosa
Nitrate	NA

Monitoring of Raw water/Bore well water

In-house / as per  Water system Requirement

As per USP<1231 b=""> SOURCE OR FEED WATER CONSIDERATIONS

To ensure adherence to certain minimal chemical and microbiological quality standards, water used in the production of drug substances or as source or feed water for the preparation of the various types of purified waters must meet the requirements of the National Primary Drinking Water Regulations (NPDWR) (40 CFR 141) issued by the U.S. Environmental Protection Agency (EPA) or the drinking water regulations of the European Union or Japan, or the WHO drinking water guidelines. Limits on the types and quantities of certain organic and inorganic contaminants ensure that the water will contain only small, safe quantities of potentially objectionable chemical species. Therefore, water pretreatment systems will only be challenged to remove small quantities of these potentially difficult-to-remove chemicals. Also, control of objectionable chemical contaminants at the source-water stage eliminates the need to specifically test for some of them (e.g., trihalomethanes and heavy metals) after the water has been further purified.

Microbiological requirements of drinking water ensure the absence of coliforms, which, if determined to be of fecal origin, may indicate the potential presence of other potentially pathogenic microorganisms and viruses of fecal origin. Meeting these microbiological requirements does not rule out the presence of other microorganisms, which could be considered undesirable if found in a drug substance or formulated product.

To accomplish microbial control, municipal water authorities add disinfectants to drinking water. Chlorine-containing and other oxidizing substances have been used for many decades for this purpose and have generally been considered to be relatively innocuous to humans. However, these oxidants can interact with naturally occurring organic matter to produce disinfection by-products (DBPs), such as trihalomethanes (THMs, including chloroform, bromodichloromethane, and dibromochloromethane) and haloacetic acids (HAAs, including dichloroacetic acid and trichloroacetic acid). The levels of DBPs produced vary with the level and type of disinfectant used and the levels and types of organic materials found in the water, which can vary seasonally.

Because high levels of DBPs are considered a health hazard in drinking water, drinking water regulations mandate their control to generally accepted nonhazardous levels. However, depending on the unit operations used for further water purification, a small fraction of the DBPs in the starting water may carry over to the finished water. Therefore, the importance of having minimal levels of DBPs in the starting water, while achieving effective disinfection, is important.

DBP levels in drinking water can be minimized by using disinfectants such as ozone, chloramines, or chlorine dioxide. Like chlorine, their oxidative properties are sufficient to damage some pretreatment unit operations and must be removed early in the pretreatment process. The complete removal of some of these disinfectants can be problematic. For example, chloramines may degrade during the disinfection process or during pretreatment removal, thereby releasing ammonia, which in turn can carry over to the finished water. Pretreatment unit operations must be designed and operated to adequately remove the disinfectant, drinking water DBPs, and objectionable disinfectant degradants. A serious problem can occur if unit operations designed to remove chlorine were, without warning, challenged with chloramine-containing drinking water from a municipality that had been mandated to cease use of chlorine disinfection to comply with ever-tightening EPA Drinking Water THM specifications. The dechlorination process might incompletely remove the chloramine, which could irreparably damage downstream unit operations, but also the release of ammonia during this process might carry through pretreatment and prevent the finished water from passing compendial conductivity specifications. The purification process must be reassessed if the drinking water disinfectant is changed, emphasizing the need for a good working relationship between the pharmaceutical water manufacturer and the drinking water provider.