L-(+)-Tartaric Acid, Granular, N.F., Multi-Compendial, J.T.Baker®
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l-(+)-tartaric acid, granular, n.f., multi-compendial, j.t.baker®
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L-(+)-Tartaric Acid, Granular, N.F., Multi-Compendial, J.T.Baker®
Formula: HOCO(CHOH)2COOH
Formula Weight: 150.09
| TEST |
SPECIFICATION |
| GMP Manufactured Product |
| Meets B.P. Chemical Specifications |
| Meets E.P. Chemical Specifications |
| Meets J.P. Chemical Specifications |
| Meets N.F. Requirements |
| CAUTION: For Manufacturing, processing or repackaging |
| Bulk Pharmaceutical Chemical |
| NF- Identification A |
Passes Test |
| NF- Identification B |
Passes Test |
| NF- Specific Rotation [Å]25^D(calculated on dried basis)( ) |
12.0 - 13.0 Degree |
| NF- Loss on Drying |
<= 0.5% |
| NF- Residue on Ignition |
<= 0.1% |
| NF- Oxalate (C2O4) |
Passes Test |
| NF- Sulfate (SO4) |
Passes Test |
| NF- Assay (HOCO(CHOH)2COOH) (dried basis) |
99.7 - 100.5% |
| NF- Endotoxin Concentration (EU/g) |
<= 10 |
| EP/BP- Assay (HOCO(CHOH)2COOH) (dried basis) |
99.5 - 101.0% |
| EP/BP- Identification A |
Passes Test |
| EP/BP- Identification B |
Passes Test |
| EP/BP- Appearance of Solution |
Passes Test |
| EP/BP- Specific Rotation [Å]²º^D ( ) |
12.0 - 12.8 Degree |
| EP/BP- Oxalic Acid |
<= 360 ppm |
| EP/BP- Chloride (Cl) |
<= 100 ppm |
| EP/BP- Sulfate (SO4) |
<= 150 ppm |
| EP/BP- Calcium (Ca) |
<= 200 ppm |
| EP/BP- Loss on Drying at 105°C |
<= 0.2% |
| EP/BP- Ash (sulfated) |
<= 0.1% |
| JP- Assay (HOCO(CHOH)2COOH) (dried basis) |
99.7 - 101.0% |
| JP- Identification A |
Passes Test |
| JP- Identification B |
Passes Test |
| JP- Sulfate (SO4) |
<= 0.048% |
| JP- Oxalate (C2O4) |
Passes Test |
| JP- Heavy Metals (as Pb) |
<= 10 ppm |
| JP- Calcium (Ca) |
Passes Test |
| JP- Arsenic (As) |
<= 1 ppm |
| JP- Loss on Drying |
<= 0.5% |
| JP- Residue on Ignition |
<= 0.05% |
| No Class 1,2,3 or other solvents are used or produced in the manufacturing or purification of the product. |
| |
| The USP Organic Volatile Impurities <467> requirements for this product is met by the implementation of Residual Solvents <467> as per the USP Revision Bulletin of June 15, 2007. |
| 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. |
| CAS Number |
87-69-4 |
| HTS Number |
2918120000 |
| Density |
1L = 1.76kg |
| Management of Change |
R |