JT Baker® 0122-R Citric Acid, Anhydrous, Powder, USP Grade, 200Lb Lined Fiber Drum
Item Number:JTB-0122-R
Manufacturer Part No:JT-0122-R
Manufacturer:Avantor
Units:200Lb Lined Fiber Drum
Details
- 200Lb Lined Fiber Drum
Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| Meets U.S.P Requirements | |
| Preserve in Tight Containers | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (HOC(COOH)(CH₂COOH)₂) (anhydrous basis) | 99.5 - 100.5 % |
| USP - Clarity of Solution | Passes Test |
| USP - Color of Solution | Passes Test |
| USP - Identification | Passes Test |
| USP - Residue on Ignition | <= 0.1 % |
| USP - Heavy Metals (as Pb) | <= 0.001 % |
| USP - Oxalic Acid | <= 0.036 % |
| USP - Sulfate (SO₄) | <= 0.015 % |
| USP - Readily Carbonizable Substances | Passes Test |
| USP - Identification C: Water (H₂O) | <= 1.0 % |
| 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. | |
| Meets Reagent Specifications for testing USP/NF monographs | |
| 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. | |
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Product Specifications
| TEST | SPECIFICATION |
| GMP Manufactured Product | |
| Meets U.S.P Requirements | |
| Preserve in Tight Containers | |
| CAUTION: For Manufacturing, processing or repackaging | |
| Bulk Pharmaceutical Chemical | |
| USP - Assay (HOC(COOH)(CH₂COOH)₂) (anhydrous basis) | 99.5 - 100.5 % |
| USP - Clarity of Solution | Passes Test |
| USP - Color of Solution | Passes Test |
| USP - Identification | Passes Test |
| USP - Residue on Ignition | <= 0.1 % |
| USP - Heavy Metals (as Pb) | <= 0.001 % |
| USP - Oxalic Acid | <= 0.036 % |
| USP - Sulfate (SO₄) | <= 0.015 % |
| USP - Readily Carbonizable Substances | Passes Test |
| USP - Identification C: Water (H₂O) | <= 1.0 % |
| 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. | |
| Meets Reagent Specifications for testing USP/NF monographs | |
| 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. | |