JT Baker® 0119-05 Citric Acid, Monohydrate, Granular, USP Grade & FCC Grade, 2.5Kg Poly Bottle (Case of 4)
Item Number:JTB-0119-05
Manufacturer Part No:JT-0119-05
Manufacturer:Avantor
Units:4 x 2.5Kg Poly Bottles/Case
Details
- 4 x 2.5Kg Poly Bottles/Case
Product Specifications
| TEST | SPECIFICATION |
| Food GMP Manufactured Product | |
| GMP Manufactured Product | |
| Meets F.C.C. Requirements | |
| Meets U.S.P Requirements | |
| Preserve in Tight Containers | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Food Chemical | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (as C₆H₈O₇) (calculated on anhydrous basis) | 99.5 - 100.5 % |
| USP - Clarity of Solution | Passes Test |
| USP - Color of Solution | Passes Test |
| USP - Identification (USP) | Passes Test |
| USP - Water (H₂O) (U.S.P.) | 7.5 - 9.0 % |
| USP - Residue on Ignition | <= 0.05 % |
| USP - Oxalic Acid (USP) | <= 0.036 % |
| USP - Sulfate (SO₄) | <= 0.015 % |
| USP - Heavy Metals (as Pb) | <= 0.001 % |
| USP - Readily Carbonizable Substances | Passes Test |
| FCC - Assay (as C₆H₈O₇) (calculated on anhydrous basis) | 99.5 - 100.5 % |
| FCC - Identification (FCC) | Passes Test |
| FCC - Water (H₂O) (F.C.C.) | <= 8.8 % |
| FCC - Residue on Ignition | <= 0.05 % |
| FCC - Oxalate (C₂O₄) (FCC) | Passes Test |
| FCC - Readily Carbonizable Substances | Passes Test |
| FCC - Lead (Pb) | <= 0.5 mg/kg |
| Appearance (white, crystalline powder) | Passes Test |
| Must be subjected to further processing during the preparation of | |
| injectable dosage forms | |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| Metallic Residues: No metal catalysts or metal reagents, as defined by | |
| EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | |
| this material. | |
Documents & Videos
Product Specifications
| TEST | SPECIFICATION |
| Food GMP Manufactured Product | |
| GMP Manufactured Product | |
| Meets F.C.C. Requirements | |
| Meets U.S.P Requirements | |
| Preserve in Tight Containers | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Food Chemical | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (as C₆H₈O₇) (calculated on anhydrous basis) | 99.5 - 100.5 % |
| USP - Clarity of Solution | Passes Test |
| USP - Color of Solution | Passes Test |
| USP - Identification (USP) | Passes Test |
| USP - Water (H₂O) (U.S.P.) | 7.5 - 9.0 % |
| USP - Residue on Ignition | <= 0.05 % |
| USP - Oxalic Acid (USP) | <= 0.036 % |
| USP - Sulfate (SO₄) | <= 0.015 % |
| USP - Heavy Metals (as Pb) | <= 0.001 % |
| USP - Readily Carbonizable Substances | Passes Test |
| FCC - Assay (as C₆H₈O₇) (calculated on anhydrous basis) | 99.5 - 100.5 % |
| FCC - Identification (FCC) | Passes Test |
| FCC - Water (H₂O) (F.C.C.) | <= 8.8 % |
| FCC - Residue on Ignition | <= 0.05 % |
| FCC - Oxalate (C₂O₄) (FCC) | Passes Test |
| FCC - Readily Carbonizable Substances | Passes Test |
| FCC - Lead (Pb) | <= 0.5 mg/kg |
| Appearance (white, crystalline powder) | Passes Test |
| Must be subjected to further processing during the preparation of | |
| injectable dosage forms | |
| No Class 1,2,3 or other solvents are used or produced in the | |
| manufacturing or purification of the product. | |
| Metallic Residues: No metal catalysts or metal reagents, as defined by | |
| EMA Guideline EMEA/CHMP/SWP/4446/2000 , are used in the production of | |
| this material. | |