- Description
- Product Details
- Additional Information
Description
This product is restricted and will only be sold and shipped to approved customers
Synonyms: Hydroxytricarballylic acid , 2-Hydroxy-1,2,3-propanetricarboxilic acid
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Formula: C₆H₈O₇.H₂O Melting Pt: 135…152 °C Density: 1.54 g/cm³ Flash Pt: 173.9 °C (closed cup) |
MDL Number: MFCD00149972 CAS Number: 5949-29-1 Merck Index: 13,02350 |
Product Details
| 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 (C₆H₈O₇) (anhydrous basis) | 99.5 - 100.5 % |
| USP - Clarity of Solution | Passes Test |
| USP - Color of Solution | Passes Test |
| USP - Identification | Passes Test |
| USP - Oxalic Acid | ≤ 0.036 % |
| USP - Readily Carbonizable Substances | Passes Test |
| USP - Residue on Ignition | ≤ 0.1 % |
| USP - Sulfate (SO₄) | ≤ 0.015 % |
| USP - Water (H₂O) | 7.5 - 9.0 % |
| EP/BP - Assay (C₆H₈O₇) (anhydrous basis) | 99.5 - 100.5 % |
| EP/BP - Appearance of Solution | Passes Test |
| EP/BP - Ash (sulfated) | ≤ 0.1 % |
| EP/BP - Endotoxin Concentration, IU/mg | ≤ 0.5 |
| EP/BP - Identification B | Passes Test |
| EP/BP - Identification E | Passes Test |
| EP/BP - Oxalic Acid | ≤ 360 ppm |
| EP/BP - Readily Carbonizable Substances | Passes Test |
| EP/BP - Sulfate (SO₄) | ≤ 150 ppm |
| EP/BP - Water (H₂O) | 7.5 - 9.0 % |
| JP - Assay (HOC(COOH)(CH₂COOH)₂H₂O) | 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 - Water (H₂O) | 7.5 - 9.0 % |
| JP - Readily Carbonizable Substances | Passes Test |
| JP - Residue on Ignition | ≤ 0.10 % |
| JP - Sulfate (SO₄) | ≤ 150 ppm |
| ACS - Iron (Fe) | ≤ 3 ppm |
| Lead (Pb) | ≤ 2 ppm |
| 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. | |
| 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. |