CAS No.: | 56038-13-2 |
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Formula: | C12h19cl3o8 |
Type: | Sorbitol |
Nutritional Value: | Nutritional |
Effect: | Stabilization |
Resource: | Natural |
Samples: |
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Customization: |
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ITEM | STANDARD | RESULT |
Identification A(IR) | Infrared spectra of standard and sample should meet each other | Pass |
Identification B (Retention time of HPLC) |
The retention time of the principal peak of the sample solution corresponds to that of the standard solution,as obtained in the Assay. | Pass |
Identification C(By TLC) |
The Rf value of the major spot in the thin-layer chromatogram of the Product Preparation is the same as that of the Standard Preparation obtained in the test for Related Substances. |
Pass |
Appearance | White crystalline powder | Pass |
Assay,% | 98.0~102.0 | 99.94 |
Specific Rotation,º | +84.0~+87.5 | +86.1 |
Moisture,% | ≤2.0 | 0.1 |
PH (10% aqucous solution) | 5.0-7.0 | 5.62 |
Ignited Residue,% | ≤0.7 | 0.1 |
Methanol,% | ≤0. 1 | 0.01 |
Heavy Metals (as lead) ,mg/kg | ≤10 | <10 |
Arsenic(As),mg/kg | ≤3 | <1 |
Lead,mg/kg | ≤1 | Not Detected |
Triphenylphosphine Oxide,mg/kg | ≤150 | <150 |
Hydrolysis Products,% | ≤0.1 | Pass |
Related Substances,% | ≤0.5 | Pass |
Total Aerobic count,cfu/g | ≤250 | 30 |
Yeasts & moulds,cfu/g | ≤50 | 10 |
Coliform,MPN/g | <3.0 | <3.0 |
E.coli | Negative | Negative |
S.aureus | Negative | Negative |
Salmonella | Negative | Negative |
Storage condition | Store in well closed container, in dry and cool place, at a temperature not exceeding 21C. |
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Conclusion | The quality in conformity with the E-955/USP 36 / FCC 8 |
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