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 Post subject: USP grade water
PostPosted: Wed Jul 11, 2018 1:59 pm 
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USP sterile water for injection can be a very useful ingredient to have around when formulating injectables. Problem is, here in the USA, a prescription is needed for purchase. It seems to me that USP Sterile Water for Irrigation should be a useful stock compound to manufacture a water very similar to USP grade Sterile Water for Injection! From the below descriptions, the particulate matter is the only USP difference in those two grades. I would bet 99 to 1 that our pharmaceutical industry in the name of cost efficiency does not manufacture those two grades in different ways at different plants, but rather simply make the higher grade water to satisfy both, but put the final water in different containers for sale which meets the USP guidelines. The same is done in the oxygen industry where in the USA, all oxygen is made to USP medical grade standards, but at the end of the assembly line, one is put in medical USP approve containers and the other in industrial welding tanks.

One should be able to use the much easier to purchase USP Sterile Water for Irrigation and convert it to USP Sterile Water for Injection by simply filtering it in a sterile system. To be on the safe side, one simply needs to run USP Water for Irrigation through a .22 μm sterile filter to produce a product very similar to USP Water for Injection! Using a closed sterile .22 micron system like that pictured below, would be the desirable, easily obtainable solution and eliminate both particulate and microbiological contamination at one fail swoop.

Attachment:
nalgene_filter_2.jpg







Quote:
STERILE PURIFIED WATER

Purified Water, packaged and rendered sterile. It can be used in the prepara-tion of nonparenteral compendial dosage forms or in analytical applications requiring Purified Water where 1) access to a validated Purified Water system is not practical, 2) only a relatively small quantity is needed, 3) Sterile Purified Water is required by specific monograph or pharmacy practice, or 4) bulk packaged Purified Water is not suitably controlled for the microbiological quality for its intended use.


STERILE WATER FOR INJECTION

Water for Injection, packaged and rendered sterile. It is used for extemporaneous prescription compounding and as a sterile diluent for parenteral products. It may also be used for other applications where bulk Water for Injection or Purified Water is indicated but access to a validated water system is not practical, or where only a relatively small quantity is needed. Sterile Water for Injection is packaged in single-dose containers not larger than 1 L.


BACTERIOSTATIC WATER FOR INJECTION

Water for Injection, packaged and rendered sterile, to which has been added one or more suitable antimicrobial preservatives. It is intended to be used as a diluent in the preparation of parenteral products, most typically for multi-dose products that require repeated content withdrawals. It may be packaged in single-dose or multiple-dose containers not larger than 30 mL.


STERILE WATER FOR IRRIGATION

Water for Injection packaged and sterilized in single-dose containers which may be larger than 1 L and allow rapid delivery of their contents. Due to its usage, Sterile Water for Irrigation is not required to meet Particulate Matter in Injections. It may also be used in other applications that do not have particulate matter specifications, where bulk Water for Injection or Purified Water is indicated but where access to a validated water system is not practical, or where somewhat larger quantities are needed than are provided as Sterile Water for Injection.


STERILE WATER FOR INHALATION
Sterile Water for Inhalation

Water for Injection that is packaged and rendered sterile and is intended for use in inhalators and in the preparation of inhalation solutions. This monograph has no requirement to meet ; it carries a less stringent specification for bacterial endotoxins than Sterile Water for Injection, and therefore is not suitable for parenteral applications.



Quote:
FILTERED WATER

Filtered Water is Purified Water that has been filtered to remove particles that could interfere with the analysis where this water is specified. It is sometimes used synonymously with Particle-Free Water and Ultra-Filtered Water and is cited in some monographs and general chapters as well as in Reagents, Indicators, and Solutions. Depending on its referenced location in USP–NF, it is variously defined as water that has been passed through filters rated as 1.2, 0.2, or 0.22 μm, or unspecified porosity rating. Even though the water names and the filter ratings used to produce these waters are defined inconsistently, the use of 0.2-mm or 0.22-μm filtered Purified Water should be universally acceptable for all applications where Particle-Free Water, Filtered Water, or Ultra-Filtered Water are specified.


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