Sodium Bicarbonate, Powder USP, FCC, Suitable for Use in Hemodialysis, Macron™
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Sodium Bicarbonate, Powder USP, FCC, Suitable for Use in Hemodialysis, Macron™
Formula: NaHCO3
Formula Weight: 84.01
Suitable for Use in Hemodialysis
| TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets U.S.P. Requirements |
Assay (NaHCO3)
(dried basis)(by acidimetry) |
99.0 - 100.5% |
| Aluminum (Al) |
max. 2 ppm |
| Arsenic (As) |
max. 2 ppm |
| Calcium (Ca) |
max. 0.01% |
| Carbonate (CO3) |
max. 0.23% |
| Chloride (Cl) |
max. 0.015% |
| Copper (Cu) |
max. 1 ppm |
| Heavy Metals (as Pb)(μg/g) |
max. 5 |
| Identification A |
Passes Test |
| Identification B |
Passes Test |
| Insoluble Substances |
Passes Test |
| Iron (Fe) |
max. 5 ppm |
| Limit of Ammonia (NH3) |
Passes Test |
| Limit of Sulfur Compounds |
max. 0.015% |
| Loss on Drying |
max. 0.25% |
| Magnesium (Mg) |
max. 0.004% |
| Normal Carbonate |
Passes Test |
| Limit of Organics |
max. 0.01% |
| |
| Meets F.C.C. Requirements |
Assay (NaHCO3)
(dried basis)(by acidimetry) |
99 - 100.5% |
| Ammonia (as NH3) |
Passes Test |
| Identification A |
Passes Test |
| Identification B |
Passes Test |
| Insoluble Substances |
Passes Test |
| Lead (Pb) |
max 2 mg/kg |
| Loss on Drying |
max. 0.25% |
| |
| Product Information (not specifications): |
| Appearance (white, crystalline powder) |
| The net weight of the product in each container is within ±2% of the netweight stated on the label. |
| |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |
| Bulk Food Chemical |
| Bulk Pharmaceutical Chemical |
| CAUTION: For manufacturing, processing or repacking. |
| For a Certificate of Lot Analysis, visit www.avantormaterials.com. |
| Preserve in well-closed containers. |
| CAS Number |
144-55-8 |
| HTS Number |
2836300000 |
| Specific Gravity |
1L = 2.20 Kg |
| Storage Color Code |
Green |
| Management of Change |
R |