Potassium citrate (Tripotassium Citrate)
City: Marupe
Please avoid sudden changes in temperature and humidity, as they may affect the condition of derivative ingredients and tablets.
The shelf life begins from the date of manufacture at the factory.
Taking into account logistical and transportation stages, the remaining shelf life of the product is always shorter than the full shelf life.
We ship products to our customers with a remaining shelf life of no less than 70%.
CERTIFICATE OF ANALYSIS
Field | Value |
Batch | 3066863 |
Date of production | 17.10.2024 |
Date of expiry | 10.2029 |
Product | Tripotassium citrate monohydrate E332, F6001 |
Characteristics | Transparent crystals or a white, granular powder, odorless. Freely soluble in water, very slightly soluble in alcohol. |
Results of Analysis
Parameter | Unit | Specification | Value |
Characteristics |
| meets the requirements | conforms |
Identification |
| meets the requirements | conforms |
Appearance of solution |
| clear and colourless | conforms |
Acidity or Alkalinity |
|
| conforms* |
pH (5%) |
| 7,5 - 9,0 | 8,8 |
Arsenic | mg/kg | <= 1 | <= 1* |
Lead | mg/kg | <= 0,5 | <= 0,5* |
Mercury | mg/kg | <= 0,5 | <= 0,5* |
Cadmium | mg/kg | <= 0,5 | <= 0,5* |
Sodium | % | <= 0,3 | <= 0,3 |
Assay as potassium | % | 35,6 - 36,2 | 36,0 |
Chloride | mg/kg | <= 15 | <= 15 |
Oxalic acid / oxalates | mg/kg | <= 100 | <= 100* |
Sulphate | mg/kg | <= 100 | <= 100 |
Readily carbonisable substances |
| meets the requirements | conforms* |
Loss on drying | % | 4,0 - 6,0 | 5,6 |
Water (KF) | % | 4,0 - 6,0 | 5,5 |
Assay | % | 99,0 - 100,5 | 99,9 |
Organic volatile impurities |
|
| conforms* |
Tartrates |
|
| conforms* |
Particles on 0,60 mm | % | <= 10,0 | 1,7 |
Particles through 0,20 mm | % | <= 15,0 | 3,7 |
Notes
Item | Text |
Standards | Product is specified to meet the requirements of the latest edition of the European Pharmacopoeia (Ph. Eur.), the United States Pharmacopoeia (USP), the Food Chemicals Codex (FCC) and Commission Regulation (EU) No 231/2012. |
GMO | This product is considered not genetically modified and not derived from genetically modified organisms. |
Allergens | This product does not contain substances having allergenic properties for which labelling is required, as defined in Annex II of Regulation (EU) 1169/2011. |