JT Baker® 0119-05 Citric Acid, Monohydrate, Granular, USP Grade & FCC Grade, 2.5Kg Poly Bottle (Case of 4)
- 4 x 2.5Kg Poly Bottles/Case
- Manufacturer Part No: JT-0119-05
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Details
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. |
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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. |