Macron™ 7788-06 Citric Acid, Monohydrate, Granular, GenAR USP Grade, 2.5Kg Poly Pail
- 2.5Kg Poly Pail
- Manufacturer Part No: MK-7788-06
PLEASE NOTE: Product images and descriptions may not exactly represent the product. Prior to making your purchase, please confirm that the manufacturer part number shown above matches the product you seek. Returns are not allowed for such differences if the correct manufacturer part number is shipped.
Details
Product Information
CAS Number | 5949-29-1 |
HTS Number | 2918140000 |
Density | 1L = 1.54 Kg |
Management of Change | R |
Product Specifications
TEST | SPECIFICATION |
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
Preserve in Tight Containers | |
CAUTION: For Manufacturing, processing or repackaging | |
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 | Passes Test |
USP - Water (H₂O) | 7.5 - 9.0 % |
USP - Residue on Ignition | <= 0.1 % |
USP - Readily Carbonizable Substances | Passes Test |
USP - Oxalic Acid | <= 0.036 % |
USP - Sulfate (SO₄) | <= 0.015 % |
EP/BP - Assay (as C₆H₈O₇) (calculated on anhydrous basis) | 99.5 - 100.5 % |
EP/BP - Identification B | Passes Test |
EP/BP - Identification E | Passes Test |
EP/BP - Oxalic Acid | <= 360 ppm |
EP/BP - Sulfate (SO₄) | <= 150 ppm |
EP/BP - Ash (sulfated) | <= 0.1 % |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Readily Carbonizable Substances | Passes Test |
EP/BP - Water (H₂O) | 7.5 - 9.0 % |
JP - Assay (C₆H₈O₇) (anhydrous basis) | 99.5 - 100.5 % |
JP - Clarity and Color of Solution | Passes Test |
JP - Heavy Metals (as Pb) | <= 10 ppm |
JP - Identification | Passes Test |
JP - Oxalic Acid | <= 360 ppm |
JP - Readily Carbonizable Substances | Passes Test |
JP - Residue on Ignition | <= 0.10 % |
JP - Sulfate (SO₄) | <= 150 ppm |
JP - Water (H₂O) | 7.5 - 9.0 % |
Endotoxin Concentration (IU/mg) | <= 0.5 |
Appearance (white to colorless crystals, granules or white crystalline | |
powder; efflorescent) | |
No Class 1,2,3 or other solvents are used or produced in the | |
manufacturing or purification of the product. | |
Must be subjected to further processing during the preparation of | |
injectable dosage forms. | |
Elemental Impurities (USP <(><<)>232>, EP 5.20) - Information on | |
elemental impurities for this product is available on the associated | |
Product Regulatory Data Sheet and elemental impurity profile report. |
Documents & Videos
Product Information
CAS Number | 5949-29-1 |
HTS Number | 2918140000 |
Density | 1L = 1.54 Kg |
Management of Change | R |
Product Specifications
TEST | SPECIFICATION |
GMP Manufactured Product | |
Meets B.P. Chemical Specifications | |
Meets E.P. Chemical Specifications | |
Meets J.P. Chemical Specifications | |
Meets U.S.P Requirements | |
Preserve in Tight Containers | |
CAUTION: For Manufacturing, processing or repackaging | |
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 | Passes Test |
USP - Water (H₂O) | 7.5 - 9.0 % |
USP - Residue on Ignition | <= 0.1 % |
USP - Readily Carbonizable Substances | Passes Test |
USP - Oxalic Acid | <= 0.036 % |
USP - Sulfate (SO₄) | <= 0.015 % |
EP/BP - Assay (as C₆H₈O₇) (calculated on anhydrous basis) | 99.5 - 100.5 % |
EP/BP - Identification B | Passes Test |
EP/BP - Identification E | Passes Test |
EP/BP - Oxalic Acid | <= 360 ppm |
EP/BP - Sulfate (SO₄) | <= 150 ppm |
EP/BP - Ash (sulfated) | <= 0.1 % |
EP/BP - Appearance of Solution | Passes Test |
EP/BP - Readily Carbonizable Substances | Passes Test |
EP/BP - Water (H₂O) | 7.5 - 9.0 % |
JP - Assay (C₆H₈O₇) (anhydrous basis) | 99.5 - 100.5 % |
JP - Clarity and Color of Solution | Passes Test |
JP - Heavy Metals (as Pb) | <= 10 ppm |
JP - Identification | Passes Test |
JP - Oxalic Acid | <= 360 ppm |
JP - Readily Carbonizable Substances | Passes Test |
JP - Residue on Ignition | <= 0.10 % |
JP - Sulfate (SO₄) | <= 150 ppm |
JP - Water (H₂O) | 7.5 - 9.0 % |
Endotoxin Concentration (IU/mg) | <= 0.5 |
Appearance (white to colorless crystals, granules or white crystalline | |
powder; efflorescent) | |
No Class 1,2,3 or other solvents are used or produced in the | |
manufacturing or purification of the product. | |
Must be subjected to further processing during the preparation of | |
injectable dosage forms. | |
Elemental Impurities (USP <(><<)>232>, EP 5.20) - Information on | |
elemental impurities for this product is available on the associated | |
Product Regulatory Data Sheet and elemental impurity profile report. |