Quality Level
agency
EP 2.6.1, JP 4.06, USP 71
sterility
sterile; autoclaved
form
liquid
shelf life
360 days
feature
closure type Blue screw cap with 3 loci, ready-to-use
composition
Aqua Purificata
packaging
pack of 10 bottles
bottle capacity
125 mL
bottle filling volume
100 mL
impurities
Endotoxins, none detected, Heavy Metals (Pb), none detected, <100 cfu/mL Bacteria
pH
5.0 -7.0
conductivity
<1.1 μS/cm at 20 °C, <1.3 μS/cm at 25 °C
application(s)
cosmetics
food and beverages
pharmaceutical
storage temp.
2-25°C
suitability
nonselective for
General description
Purified Water is a universal solvent derived from non-portable water source which meets the regulatory specifications.
The low microbial counts and pH, synergistically support the usage of purified water in pharma and food industries.
The low microbial counts and pH, synergistically support the usage of purified water in pharma and food industries.
Application
Purified Water is mainly used for microbial media preparations and bulk material for non-parenteral formulations.
Apart from above, purified water finds its application in:
Preparation of Bulk Chemicals.
Apart from above, purified water finds its application in:
- Cleaning of non-parenteral production equipment′s.
- Input for WFI production.
- Non-sterile tests and assays.
Preparation of Bulk Chemicals.
Other Notes
Production will take place at Millipore SAS in Molsheim, France. Deliveries will be executed in accordance with the terms and conditions of MLS RTU GmbH. A minimum order quantity is required to process the order. Once the order is placed and confirmed, Merck will ensure product delivery within a maximum timeframe of 10 to 12 weeks. The terms and conditions of Merck KGaA apply to both Millipore SAS and MLS RTU GmbH and can be accessed through the following link: Standard Terms & Conditions
This medium can be modified and/or supplemented based on the required performance criteria.
Disclaimer
This item is created at the customer′s request as a customized product and will not be developed or qualified in accordance with the Merck Product Development Process.
存储类别
10 - Combustible liquids
wgk
nwg
flash_point_f
Not applicable
flash_point_c
Not applicable
法规信息
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全球贸易项目编号
| 货号 | GTIN |
|---|---|
| 1466700010 | 04054839382857 |