JT Baker® 0122-05 Citric Acid, Anhydrous, Powder, USP Grade, 2Kg Poly Bottle (Case of 4)
- Case of 4 x 2Kg Poly Bottles
- Manufacturer Part No: JT-0122-05
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Details
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. |