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PRODUCT SPECIFICATION
| QUALITY CONTROL DEPARTMENT | |
| Product Name | BOSWELLIA EXTRACT [AKBA 30%] |
| Botanical Name | Boswellia serrata |
| Plant part | Gum exudates |
| Standardization | 3-Acetyl-11-keto- β -Boswellic acid |
| S. No. | Parameters | Specification | Method | ||||||||||||||||||
| Physical | |||||||||||||||||||||
| 1 | Description | Off white to light brown color powder | Visual | ||||||||||||||||||
| 2 | Identification | To comply by HPLC | KVN/QC/STP-IN/008 | ||||||||||||||||||
| 3 | Loss on drying | NMT 5.0% | USP <731> | ||||||||||||||||||
| 4 | Residue on Ignition | NMT 5.0% | USP <281> | ||||||||||||||||||
| 5 | Solubility | Soluble in Alcohol | KVN/QC/STP-GT/017 | ||||||||||||||||||
| 6 | Tapped Bulk density | 0.30-0.70g/ml | USP <616> | ||||||||||||||||||
| Sieve test (passes through) | |||||||||||||||||||||
| 7 |
|
USP <786> | |||||||||||||||||||
| Chemical | |||||||||||||||||||||
| 8 |
Assay by HPLC 3-Acetyl-11-keto-β-Boswellic acid[AKBA] |
NLT 30.0% w/w on dry basis |
KVN/QC/STP-IN/008 |
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| Others | |||||||||||||||||||||
| 9 |
|
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| 10 | Residual solvents | Should comply by ICH/USP | USP <467> | ||||||||||||||||||
| Microbiological Profile | |||||||||||||||||||||
| 11 |
|
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PRODUCT SPECIFICATION
| QUALITY CONTROL DEPARTMENT | |
| Product Name | BOSWELLIA EXTRACT [β-Boswellic acids 40%] |
| Botanical Name | Boswellia serrata |
| Plant part | Gum exudates |
| Standardization | Boswellic Acids |
| S. No. | Parameters | Specification | Method | ||||||||||||||||||
| Physical | |||||||||||||||||||||
| 1 | Description | Off white to brown color powder | Visual | ||||||||||||||||||
| 2 | Identification | To comply by HPLC | KVN/QC/STP-IN/008 | ||||||||||||||||||
| 3 | Loss on drying | NMT 5.0% | USP <731> | ||||||||||||||||||
| 4 | Residue on Ignition | NMT 8.0% | USP <281> | ||||||||||||||||||
| 5 | Alcohol soluble extractives | NLT 75.0% | KVN/QC/STP-GT/026 | ||||||||||||||||||
| 6 | pH (1.0%w/v suspension in water) | 4.0- 6.0 | USP | ||||||||||||||||||
| 7 | Tapped Bulk density | 0.4-0.9 g/ml | USP <616> | ||||||||||||||||||
| Sieve test (passes through) | |||||||||||||||||||||
| 8 | #60 mesh | NLT 95.0% w/w | USP <786> | ||||||||||||||||||
| Chemical | |||||||||||||||||||||
| 9 |
Assay By Titration content of Total Boswellic acids |
NLT 75.0% w/w on dry basis | KVN/QC/STP- GT/010 | ||||||||||||||||||
| 10 |
β-Boswellic acids by HPLC 11-keto-β-Boswellic acid 3-Acetyl-11-keto-β-Boswellic acid β-Boswellic acid 3-Acetyl-β-Boswellic acid |
NLT 40.0% w/w on dry basis | KVN/QC/STP-IN/008 | ||||||||||||||||||
| Others | |||||||||||||||||||||
| 11 |
|
||||||||||||||||||||
| 12 | Residual solvents | Should comply by ICH/USP | USP <467> | ||||||||||||||||||
| Microbiological Profile | |||||||||||||||||||||
| 13 |
|
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