Foothill Ranch, CA
ACTA tests Purified Water, Water for Injection, Process Water, and Packaged Water to the USP compendial chapters for total organic carbon, conductivity, bacterial endotoxin, and microbial enumeration. Send us the system and the tests, and a scientist scopes the work.
Purified Water and Water for Injection are defined by the tests that pass. ACTA runs the full compendial panel and reports each result against the USP limit, so your quality group has release-ready data.
Detects trace organic compounds in the water. The bulk water limit is 0.50 mg/L (500 ppb). Run in the lab or by online limit response.
Measures dissolved ions such as sodium and chloride by how well the water conducts electricity, evaluated in the three stage USP procedure.
Required for Water for Injection, with a limit of 0.25 EU/mL. Purified Water has no compendial endotoxin requirement.
Total aerobic microbial count by USP <61>, with tests for specified microorganisms by <62>, counted against the action levels defined in <1231>.
Subvisible particulate testing by both Method 1 (light obscuration) and Method 2 (microscopic), for injectable and sterile waters.
ACTA measures TOC and conductivity and evaluates each result against the USP acceptance criteria, then reports the numbers your quality group needs to release a batch or investigate a water system.
| Attribute | Purified Water | Water for Injection |
|---|---|---|
| <643> Total Organic Carbon | 0.50 mg/L max (500 ppb) | 0.50 mg/L max (500 ppb) |
| <645> Water Conductivity | Stages 1 to 3 per USP | Stages 1 to 3 per USP |
| <85> Bacterial Endotoxin | Not required | 0.25 EU/mL max |
| <1231> Microbial action level | NMT 100 CFU/mL | NMT 10 CFU/100 mL |
Water for Injection is the stricter grade. It adds bacterial endotoxin control and a far tighter microbial action level for injectable use. Sterility testing (USP <71>) is out of scope.
Large labs pass on small water testing projects, or take a month just to open an account. ACTA runs them. We get back to you, we follow up, and the work grows from there. You get an FDA registered, DEA licensed, cGMP lab that treats a small account like an account.
FDA registered. DEA licensed for Schedules I to V. cGMP compliant. Analyzing pharmaceutical and medical device samples since 1990.
